Safety, Tolerability, and Immunogenicity Study of Homologous Ad26 Mosaic Vector Vaccine Regimens or Heterologous Ad26 Mosaic and MVA Mosaic Vector Vaccine Regimens With Glycoprotein 140 (gp140) for Human Immunodeficiency Virus (HIV) Prevention
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the safety and tolerability of various regimens containing adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV), Modified Vaccinia Ankara (MVA)-Mosaic, and/or HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) components and to compare envelope binding antibody responses between the different vaccine regimens.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
This is a multicenter (more than 1 hospital or medical school team work on a study), randomized (the study drug is assigned by chance), parallel group (each group of participants will be treated at the same time), placebo-controlled (study in which the experimental treatment or procedure is compared to a pretend treatment with no drug in it to test if the drug has a real effect), and double-blind (neither physician nor participant knows the treatment that the participant receives) study. All eligible participants will be randomly assigned to receive 1 of the 8 vaccine regimens. Participants will receive study vaccines (Ad26.Mos.HIV, MVA-Mosaic, gp140 DP, and placebo) 4 times as per assigned regimen. The study comprises a Screening Period (up to 4 weeks), a Vaccination Period (participants will be vaccinated at Baseline (Week 0), Week 12, Week 24 and Week 48), and a Follow-up Period (up to 48 weeks). A long-term follow-up period (approximately 2 years after Week 96) will continue for participants randomized to the regimen subsequently selected for future studies, based on analysis of Week 28 data. If Week 28 data are inconclusive, Week 52 data will be considered for regimen selection. If no clear decision can be made, the extended follow-up period could include participants from more than 1 group for assessing durability of immune responses. Participants' safety will be monitored throughout the study.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Group 1 Participants will receive adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) vaccine at Week 0 and 12; followed by Ad26.Mos.HIV vaccine + HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) vaccine containing 250 microgram (mcg) of total protein mixed with adjuvant (aluminum phosphate) at Week 24 and 48. |
Biological: Ad26.Mos.HIV
Recombinant replication-deficient Ad26 vectored vaccine and consists of 3 Ad26 vectors, one containing a mosaic insert of envelop (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5*10^10 viral particle per 0.5 milliliter (mL) injection administered intramuscularly.
Biological: gp140 DP High-dose
The gp140 DP vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 mL injection administered intramuscularly.
|
Experimental: Group 2 Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by Ad26.Mos.HIV vaccine + gp140 DP vaccine containing 50 mcg of total protein mixed with adjuvant at Week 24 and 48. |
Biological: Ad26.Mos.HIV
Recombinant replication-deficient Ad26 vectored vaccine and consists of 3 Ad26 vectors, one containing a mosaic insert of envelop (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5*10^10 viral particle per 0.5 milliliter (mL) injection administered intramuscularly.
Biological: gp140 DP Low-dose
The gp140 DP vaccine containing 50 mcg of total protein, mixed with aluminum phosphate adjuvant (0.425 mg aluminum), per 0.5 mL injection administered intramuscularly.
|
Experimental: Group 3 Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by Ad26.Mos.HIV vaccine + placebo injection at Week 24 and 48. |
Biological: Ad26.Mos.HIV
Recombinant replication-deficient Ad26 vectored vaccine and consists of 3 Ad26 vectors, one containing a mosaic insert of envelop (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5*10^10 viral particle per 0.5 milliliter (mL) injection administered intramuscularly.
Drug: Placebo
Normal saline, 0.5 mL injection administered intramuscularly.
|
Experimental: Group 4 Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by modified Vaccinia Ankara (MVA)-Mosaic vaccine + gp140 DP vaccine containing 250 mcg of total protein mixed with adjuvant at Week 24 and 48. |
Biological: Ad26.Mos.HIV
Recombinant replication-deficient Ad26 vectored vaccine and consists of 3 Ad26 vectors, one containing a mosaic insert of envelop (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5*10^10 viral particle per 0.5 milliliter (mL) injection administered intramuscularly.
Biological: MVA-Mosaic
Recombinant live attenuated MVA virus-vectored vaccine that has been genetically engineered to express 2 mosaic Gag, Pol, and Env sequences (Mosaic 1 and Mosaic 2). Total dose is 10^8 plaque-forming unit per 0.5 mL injection administered intramuscularly.
Biological: gp140 DP High-dose
The gp140 DP vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 mL injection administered intramuscularly.
|
Experimental: Group 5 Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by MVA-Mosaic vaccine + gp140 DP vaccine containing 50 mcg of total protein mixed with adjuvant at Week 24 and 48. |
Biological: Ad26.Mos.HIV
Recombinant replication-deficient Ad26 vectored vaccine and consists of 3 Ad26 vectors, one containing a mosaic insert of envelop (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5*10^10 viral particle per 0.5 milliliter (mL) injection administered intramuscularly.
Biological: MVA-Mosaic
Recombinant live attenuated MVA virus-vectored vaccine that has been genetically engineered to express 2 mosaic Gag, Pol, and Env sequences (Mosaic 1 and Mosaic 2). Total dose is 10^8 plaque-forming unit per 0.5 mL injection administered intramuscularly.
Biological: gp140 DP Low-dose
The gp140 DP vaccine containing 50 mcg of total protein, mixed with aluminum phosphate adjuvant (0.425 mg aluminum), per 0.5 mL injection administered intramuscularly.
|
Experimental: Group 6 Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by MVA-Mosaic vaccine + placebo injection at Week 24 and 48. |
Biological: Ad26.Mos.HIV
Recombinant replication-deficient Ad26 vectored vaccine and consists of 3 Ad26 vectors, one containing a mosaic insert of envelop (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5*10^10 viral particle per 0.5 milliliter (mL) injection administered intramuscularly.
Biological: MVA-Mosaic
Recombinant live attenuated MVA virus-vectored vaccine that has been genetically engineered to express 2 mosaic Gag, Pol, and Env sequences (Mosaic 1 and Mosaic 2). Total dose is 10^8 plaque-forming unit per 0.5 mL injection administered intramuscularly.
Drug: Placebo
Normal saline, 0.5 mL injection administered intramuscularly.
|
Experimental: Group 7 Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by gp140 DP vaccine containing 250 mcg of total protein mixed with adjuvant + placebo injection at Week 24 and 48. |
Biological: Ad26.Mos.HIV
Recombinant replication-deficient Ad26 vectored vaccine and consists of 3 Ad26 vectors, one containing a mosaic insert of envelop (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5*10^10 viral particle per 0.5 milliliter (mL) injection administered intramuscularly.
Biological: gp140 DP High-dose
The gp140 DP vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 mL injection administered intramuscularly.
Drug: Placebo
Normal saline, 0.5 mL injection administered intramuscularly.
|
Placebo Comparator: Group 8 Participants will receive 1 placebo injection at Week 0 and 12; followed by 2 placebo injections at Week 24 and 48. |
Drug: Placebo
Normal saline, 0.5 mL injection administered intramuscularly.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Solicited Local Adverse Events (AEs) Post Vaccination [Up to Week 49 (7 days post any dose)]
Solicited local AEs (at injection site) included erythema, induration, swelling, itching and warmth were collected within 7 days after vaccination.
- Percentage of Participants With Solicited Systemic Adverse Events (AEs) Post Vaccination [Up to Week 49 (7 days post any dose)]
Solicited systemic AEs included fever (defined as body temperature of 38.0-degree celsius or higher), headache, fatigue, myalgia, nausea, vomiting were collected within 7 days after vaccination.
- Percentage of Participants With Unsolicited Adverse Events Post Vaccination [Up to Week 52 (28 days post vaccination)]
Unsolicited AEs were defined as events that participants experienced but were not specifically asked about.
- Number of Participants With Serious Adverse Events (SAEs) Post Vaccination [Up to Week 96]
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. A SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product.
- Percentage of Responders for Envelop (Env) Clade A, B and C-specific Binding Antibody Titers at Week 28 [Week 28]
The Env Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012)- specific binding antibody titer were assessed using enzyme-linked immunosorbent assay (ELISA). The response was defined as post-baseline value greater than (>) lower limit of quantification (LLOQ) if baseline less than (<) LLOQ or missing or defined as post-baseline value >3-fold increase from baseline if baseline greater than or equal to (>=) LLOQ. The lower limits of quantification (LLOQs) for this assay were 625, 156.25, 625, and 156.25 endotoxin units per milliliter (EU/mL) for Clade A (92UG037.1), Clade B (1990a), Clade C (Con C), and Clade C (C97ZA.012) respectively.
Secondary Outcome Measures
- Percentage of Responders for Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) Immunoglobulin G1 (IgG1), IgG2, IgG3 and IgG4 Gylcoprotein (gp) 140 Binding Antibody [Week 28, 52 and 96]
Vaccine-induced binding antibody IgG1, IgG2, IgG3 and IgG4 subclass responses were investigated using Clade C (C97ZA.012) specific ELISAs. The response was defined as post-baseline value >LLOQ if baseline <LLOQ or missing or defined as post-baseline value >3-fold increase from baseline if baseline >=LLOQ. The LLOQs for this assay were 12.3, 28.7, 12.4, and 13.2 for IgG1, IgG2, IgG3 and IgG4 respectively. Samples taken after Week 48 (W48) from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category.
- Percentage of Responders for Env ELISA Including Consensus C and Mos1 Antigens [Week 28, 52 and 96]
The response was defined as post-baseline value >LLOQ if baseline <LLOQ or missing or defined as post-baseline value >3-fold increase from baseline if baseline >=LLOQ. The LLOQ for this assay is a 50 percent (%) inhibitory concentration (IC50) of 20 (fold-dilution). The lower limits of quantification (LLOQs) for this assay were 625 and 78.125 EU/mL for Clade C (Con C) and Mos1 respectively. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category.
- Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody [Week 16, 26, 28, 52, 78, and 96]
The functionality of vaccine-induced antibody responses was investigated by the determination of ADCP. The response was defined as post-baseline value > limit of detection (LOD) if baseline <LOD or missing or defined as post-baseline value >3-fold increase from baseline if baseline >=LOD. The lower limits of detection (LODs) for this assay were 5.16, 6.43, 6.49, 4.32 and 4.28 (phagocytic score) for Clade A (92UG037.1), Clade B (1990a), Clade C (Con C), Clade C (C97ZA.012), and Mos1, respectively. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category of Clade A, B, C and Mos 1.
- Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb) [Week 28 and 52]
The functionality of vaccine-induced antibody responses was investigated by the determination of nAb activity in a virus neutralization assay (VNA) using TZM-bl cells and Env-pseudotyped viruses. The response was defined as post-baseline value >LLOQ. The LLOQ for this assay is an inhibitory concentration (IC50) of 20 (fold-dilution). Data reported for the responses against Tier 1 HIV strain Clade C (MW965.26) was reported. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category.
- Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody [Week 16, 28, 52, 78, and 96]
The human immunodeficiency virus (HIV)-1 BAMA employs flow-cytometric-based technology that also utilizes antibody and antigen interactions to test for the presence of specific antibodies in an unknown sample with the added advantage of multiplexing the antigens of interest. Positive and negative control standards were run with each assay to ensure specificity. The positivity threshold was determined per antigen based on the plus (+) 3 standard deviation (SD) on the non-specific background. Sample values had to be greater than or equal to this value and had to be 3-fold over the baseline values with a minimum median fluorescent intensities (MFI) value of 100. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category.
- Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot) [Week 26, 50, 78 and 96]
Frozen peripheral blood mononuclear cell (PBMCs) were analyzed by interferon-gamma (IFN-gamma) (ELISpot). The response was defined as post-baseline value >P95 if baseline <P95 or missing or defined as post-baseline value >3-fold increase from baseline if baseline >=P95. The threshold for ELISpot test was based on the 95th percentile (P95) from the baseline values of participants on that test in the study. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participant must be healthy on the basis of physical examination, medical history, electrocardiogram (ECG) and laboratory criteria, and vital signs measurement performed at Screening
-
Participants are negative for human immunodeficiency virus (HIV) infection at Screening
-
All female participants of childbearing potential must have a negative serum (beta human chorionic gonadotropin) at Screening, and a negative urine pregnancy test pre-dose on Week 0, 12, 24, and 48
-
A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction until 3 months after receiving the last dose of study vaccine. A man must agree not to donate sperm until 3 months after receiving the last dose of study vaccine
-
Participants are assessed by the clinic staff as being at low risk for HIV infection
Exclusion Criteria:
-
Participant has chronic active hepatitis B or active hepatitis C, active syphilis infection, chlamydia, gonorrhea, or trichomonas. Active syphilis documented by exam or serology unless positive serology is due to past treated infection
-
In the 12 months prior to enrollment, participant has a history of newly acquired herpes simplex virus type 2 (HSV-2), syphilis, gonorrhea, non-gonococcal urethritis, chlamydia, pelvic inflammatory disease, trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranulomavenereum, chancroid, or hepatitis B
-
Participant has any clinically significant acute or chronic medical condition that in the opinion of the investigator would preclude participation (for example, history of seizure disorders, bleeding/clotting disorder, autoimmune disease, active malignancy, poorly controlled asthma, active tuberculosis or other systemic infections)
-
Participant has had major surgery within the 4 weeks prior to study entry or planned major surgery through the course of the study
-
Participant has had a thyroidectomy, or thyroid disease requiring medication during the last 12 months
-
Participant has a history of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with permanent sequelae, clinically significant arrhythmia (including any arrhythmia requiring medication, treatment, or clinical follow up)
-
Participant has an ECG (per examination and interpretation of a cardiologist) with clinically significant findings, or features that would interfere with the assessment of myo/pericarditis, including any of the following: a) conduction disturbance (complete left or complete right bundle branch block or nonspecific intraventricular conduction disturbance with QRS >=120 millisecond [ms], PR interval >=220 ms, any 2nd or 3rd degree AV block, or QTc prolongation [>450 ms]); b) significant repolarization (ST segment or T wave) abnormality; c) significant atrial or ventricular arrhythmia, frequent atrial or ventricular ectopy (for example frequent premature atrial contractions, 2 premature ventricular contractions in a row); d) ST elevation consistent with ischemia, or evidence of past or evolving myocardial infarction
-
Participant has a history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products, or neomycin or streptomycin or egg products
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Aurora | Colorado | United States | ||
2 | Miami | Florida | United States | ||
3 | Rockville | Maryland | United States | ||
4 | Boston | Massachusetts | United States | ||
5 | Austin | Texas | United States | ||
6 | Kigali | Rwanda | |||
7 | Cape Town | South Africa | |||
8 | Durban | South Africa | |||
9 | Johannesburg | South Africa | |||
10 | Bangkok | Thailand | |||
11 | Entebbe | Uganda | |||
12 | Kampala | Uganda |
Sponsors and Collaborators
- Janssen Vaccines & Prevention B.V.
- National Institute of Allergy and Infectious Diseases (NIAID)
- US Military HIV Research Program
- Beth Israel Deaconess Medical Center
- International AIDS Vaccine Initiative
Investigators
- Study Director: Janssen Vaccines & Prevention B.V. Clinical Trials, Janssen Vaccines & Prevention B.V.
Study Documents (Full-Text)
More Information
Publications
None provided.- CR106152
- HIV-V-A004
- IPCAVD009
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Group 1: Ad26/Ad26 + gp140 High Dose (HD) | Group 2: Ad26/Ad26 + gp140 Low Dose (LD) | Group 3: Ad26/Ad26 | Group 4: Ad26/MVA + gp140 HD | Group 5: Ad26/ MVA + gp140 LD | Group 6: Ad26/MVA | Group 7: Ad26/ gp140 HD | Group 8: Placebo/ Placebo |
---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48. |
Period Title: Overall Study | ||||||||
STARTED | 50 | 49 | 49 | 48 | 49 | 49 | 50 | 49 |
COMPLETED | 44 | 39 | 44 | 39 | 41 | 43 | 37 | 42 |
NOT COMPLETED | 6 | 10 | 5 | 9 | 8 | 6 | 13 | 7 |
Baseline Characteristics
Arm/Group Title | Group 1: Ad26/Ad26 + gp140 High Dose (HD) | Group 2: Ad26/Ad26 + gp140 Low Dose (LD) | Group 3: Ad26/Ad26 | Group 4: Ad26/MVA + gp140 HD | Group 5: Ad26/ MVA + gp140 LD | Group 6: Ad26/MVA | Group 7: Ad26/ gp140 HD | Group 8: Placebo/ Placebo | Total |
---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48. | Total of all reporting groups |
Overall Participants | 50 | 49 | 49 | 48 | 49 | 49 | 50 | 49 | 393 |
Age (years) [Mean (Standard Deviation) ] | |||||||||
Mean (Standard Deviation) [years] |
29.8
(7.77)
|
29.6
(7.49)
|
31.1
(8.22)
|
29.6
(7.67)
|
30.3
(7.61)
|
29.2
(8.73)
|
30.3
(7.65)
|
29
(8.06)
|
29.9
(7.86)
|
Sex: Female, Male (Count of Participants) | |||||||||
Female |
25
50%
|
26
53.1%
|
28
57.1%
|
19
39.6%
|
25
51%
|
19
38.8%
|
19
38%
|
20
40.8%
|
181
46.1%
|
Male |
25
50%
|
23
46.9%
|
21
42.9%
|
29
60.4%
|
24
49%
|
30
61.2%
|
31
62%
|
29
59.2%
|
212
53.9%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||||||||
Hispanic or Latino |
4
8%
|
6
12.2%
|
2
4.1%
|
6
12.5%
|
3
6.1%
|
5
10.2%
|
3
6%
|
6
12.2%
|
35
8.9%
|
Not Hispanic or Latino |
46
92%
|
43
87.8%
|
46
93.9%
|
42
87.5%
|
46
93.9%
|
44
89.8%
|
47
94%
|
43
87.8%
|
357
90.8%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
1
2%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
0.3%
|
Race/Ethnicity, Customized (Count of Participants) | |||||||||
American Indian or Alaska Native |
0
0%
|
0
0%
|
1
2%
|
0
0%
|
1
2%
|
0
0%
|
0
0%
|
0
0%
|
2
0.5%
|
Asian |
9
18%
|
7
14.3%
|
9
18.4%
|
7
14.6%
|
7
14.3%
|
8
16.3%
|
8
16%
|
9
18.4%
|
64
16.3%
|
Black or African American |
27
54%
|
29
59.2%
|
27
55.1%
|
27
56.3%
|
26
53.1%
|
26
53.1%
|
32
64%
|
25
51%
|
219
55.7%
|
More than one race |
0
0%
|
0
0%
|
1
2%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
0.3%
|
Other |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
4.1%
|
1
2%
|
0
0%
|
3
0.8%
|
White |
14
28%
|
13
26.5%
|
11
22.4%
|
14
29.2%
|
15
30.6%
|
13
26.5%
|
9
18%
|
15
30.6%
|
104
26.5%
|
Region of Enrollment (Count of Participants) | |||||||||
RWANDA |
7
14%
|
7
14.3%
|
10
20.4%
|
8
16.7%
|
9
18.4%
|
6
12.2%
|
5
10%
|
6
12.2%
|
58
14.8%
|
SOUTH AFRICA |
7
14%
|
10
20.4%
|
5
10.2%
|
7
14.6%
|
5
10.2%
|
7
14.3%
|
9
18%
|
6
12.2%
|
56
14.2%
|
THAILAND |
8
16%
|
7
14.3%
|
7
14.3%
|
7
14.6%
|
7
14.3%
|
7
14.3%
|
8
16%
|
7
14.3%
|
58
14.8%
|
UGANDA |
9
18%
|
7
14.3%
|
8
16.3%
|
8
16.7%
|
9
18.4%
|
10
20.4%
|
9
18%
|
11
22.4%
|
71
18.1%
|
UNITED STATES |
19
38%
|
18
36.7%
|
19
38.8%
|
18
37.5%
|
19
38.8%
|
19
38.8%
|
19
38%
|
19
38.8%
|
150
38.2%
|
Outcome Measures
Title | Percentage of Participants With Solicited Local Adverse Events (AEs) Post Vaccination |
---|---|
Description | Solicited local AEs (at injection site) included erythema, induration, swelling, itching and warmth were collected within 7 days after vaccination. |
Time Frame | Up to Week 49 (7 days post any dose) |
Outcome Measure Data
Analysis Population Description |
---|
The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. |
Arm/Group Title | Group 1: Ad26/Ad26 + gp140 High Dose (HD) | Group 2: Ad26/Ad26 + gp140 Low Dose (LD) | Group 3: Ad26/Ad26 | Group 4: Ad26/MVA + gp140 HD | Group 5: Ad26/ MVA + gp140 LD | Group 6: Ad26/MVA | Group 7: Ad26/ gp140 HD | Group 8: Placebo/ Placebo |
---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48. |
Measure Participants | 50 | 49 | 49 | 48 | 49 | 49 | 50 | 49 |
Number [percentage of participants] |
88.0
176%
|
83.7
170.8%
|
75.5
154.1%
|
77.1
160.6%
|
77.6
158.4%
|
77.6
158.4%
|
70.0
140%
|
57.1
116.5%
|
Title | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Post Vaccination |
---|---|
Description | Solicited systemic AEs included fever (defined as body temperature of 38.0-degree celsius or higher), headache, fatigue, myalgia, nausea, vomiting were collected within 7 days after vaccination. |
Time Frame | Up to Week 49 (7 days post any dose) |
Outcome Measure Data
Analysis Population Description |
---|
The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. |
Arm/Group Title | Group 1: Ad26/Ad26 + gp140 High Dose (HD) | Group 2: Ad26/Ad26 + gp140 Low Dose (LD) | Group 3: Ad26/Ad26 | Group 4: Ad26/MVA + gp140 HD | Group 5: Ad26/ MVA + gp140 LD | Group 6: Ad26/MVA | Group 7: Ad26/ gp140 HD | Group 8: Placebo/ Placebo |
---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48. |
Measure Participants | 50 | 49 | 49 | 48 | 49 | 49 | 50 | 49 |
Number [percentage of participants] |
88.0
176%
|
85.7
174.9%
|
73.5
150%
|
75.0
156.3%
|
87.8
179.2%
|
73.5
150%
|
62.0
124%
|
59.2
120.8%
|
Title | Percentage of Participants With Unsolicited Adverse Events Post Vaccination |
---|---|
Description | Unsolicited AEs were defined as events that participants experienced but were not specifically asked about. |
Time Frame | Up to Week 52 (28 days post vaccination) |
Outcome Measure Data
Analysis Population Description |
---|
The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. |
Arm/Group Title | Group 1: Ad26/Ad26 + gp140 High Dose (HD) | Group 2: Ad26/Ad26 + gp140 Low Dose (LD) | Group 3: Ad26/Ad26 | Group 4: Ad26/MVA + gp140 HD | Group 5: Ad26/ MVA + gp140 LD | Group 6: Ad26/MVA | Group 7: Ad26/ gp140 HD | Group 8: Placebo/ Placebo |
---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48. |
Measure Participants | 50 | 49 | 49 | 48 | 49 | 49 | 50 | 49 |
Number [percentage of participants] |
80.0
160%
|
73.5
150%
|
85.7
174.9%
|
87.5
182.3%
|
69.4
141.6%
|
83.7
170.8%
|
86.0
172%
|
77.6
158.4%
|
Title | Number of Participants With Serious Adverse Events (SAEs) Post Vaccination |
---|---|
Description | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. A SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product. |
Time Frame | Up to Week 96 |
Outcome Measure Data
Analysis Population Description |
---|
The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. |
Arm/Group Title | Group 1: Ad26/Ad26 + gp140 High Dose (HD) | Group 2: Ad26/Ad26 + gp140 Low Dose (LD) | Group 3: Ad26/Ad26 | Group 4: Ad26/MVA + gp140 HD | Group 5: Ad26/ MVA + gp140 LD | Group 6: Ad26/MVA | Group 7: Ad26/ gp140 HD | Group 8: Placebo/ Placebo |
---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48. |
Measure Participants | 50 | 49 | 49 | 48 | 49 | 49 | 50 | 49 |
Count of Participants [Participants] |
5
10%
|
2
4.1%
|
3
6.1%
|
4
8.3%
|
4
8.2%
|
5
10.2%
|
2
4%
|
5
10.2%
|
Title | Percentage of Responders for Envelop (Env) Clade A, B and C-specific Binding Antibody Titers at Week 28 |
---|---|
Description | The Env Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012)- specific binding antibody titer were assessed using enzyme-linked immunosorbent assay (ELISA). The response was defined as post-baseline value greater than (>) lower limit of quantification (LLOQ) if baseline less than (<) LLOQ or missing or defined as post-baseline value >3-fold increase from baseline if baseline greater than or equal to (>=) LLOQ. The lower limits of quantification (LLOQs) for this assay were 625, 156.25, 625, and 156.25 endotoxin units per milliliter (EU/mL) for Clade A (92UG037.1), Clade B (1990a), Clade C (Con C), and Clade C (C97ZA.012) respectively. |
Time Frame | Week 28 |
Outcome Measure Data
Analysis Population Description |
---|
Per protocol immunogenicity (PPI) analysis set: participants who received at least first 3 vaccines as scheduled, had at least 1 post-vaccination immunogenicity blood draw and not diagnosed with HIV. N(number of participants analyzed): participants who were evaluable for this OM. n(number analyzed): participants evaluable for specified categories. |
Arm/Group Title | Group 1: Ad26/Ad26 + gp140 High Dose (HD) | Group 2: Ad26/Ad26 + gp140 Low Dose (LD) | Group 3: Ad26/Ad26 | Group 4: Ad26/MVA + gp140 HD | Group 5: Ad26/ MVA + gp140 LD | Group 6: Ad26/MVA | Group 7: Ad26/ gp140 HD | Group 8: Placebo/ Placebo |
---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48. |
Measure Participants | 49 | 41 | 46 | 44 | 44 | 42 | 44 | 46 |
Clade A (92UG037.1) |
100.0
|
97.6
|
97.8
|
95.5
|
97.7
|
97.6
|
95.5
|
2.2
|
Clade B (1990a) |
100.0
|
100.0
|
100.0
|
100.0
|
100.0
|
100.0
|
100.0
|
6.5
|
Clade C (Con C) |
100.0
|
100.0
|
100.0
|
95.5
|
100.0
|
100.0
|
97.7
|
6.5
|
Clade C (C97ZA.012) |
100
|
100
|
100
|
97.7
|
100
|
100
|
100
|
2.2
|
Title | Percentage of Responders for Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) Immunoglobulin G1 (IgG1), IgG2, IgG3 and IgG4 Gylcoprotein (gp) 140 Binding Antibody |
---|---|
Description | Vaccine-induced binding antibody IgG1, IgG2, IgG3 and IgG4 subclass responses were investigated using Clade C (C97ZA.012) specific ELISAs. The response was defined as post-baseline value >LLOQ if baseline <LLOQ or missing or defined as post-baseline value >3-fold increase from baseline if baseline >=LLOQ. The LLOQs for this assay were 12.3, 28.7, 12.4, and 13.2 for IgG1, IgG2, IgG3 and IgG4 respectively. Samples taken after Week 48 (W48) from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category. |
Time Frame | Week 28, 52 and 96 |
Outcome Measure Data
Analysis Population Description |
---|
PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points. |
Arm/Group Title | Group 1: Ad26/Ad26 + gp140 High Dose (HD) | Group 2: Ad26/Ad26 + gp140 Low Dose (LD) | Group 3: Ad26/Ad26 | Group 4: Ad26/MVA + gp140 HD | Group 5: Ad26/ MVA + gp140 LD | Group 6: Ad26/MVA | Group 7: Ad26/ gp140 HD | Group 8: Placebo/ Placebo |
---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48. |
Measure Participants | 47 | 41 | 46 | 45 | 42 | 40 | 44 | 45 |
Clade C (C97ZA.012) IgG1 at Week 28 |
78.7
|
80.5
|
50.0
|
82.2
|
61.9
|
67.5
|
81.8
|
0.0
|
Clade C (C97ZA.012) IgG1 at Week 52 |
81.8
|
94.7
|
59.5
|
82.9
|
71.8
|
72.5
|
89.5
|
0
|
Clade C (C97ZA.012) IgG1 at Week 96 |
36.6
|
26.3
|
4.3
|
38.1
|
16.7
|
0
|
50.0
|
|
Clade C (C97ZA.012) IgG2 at Week 28 |
0
|
0
|
2.2
|
2.2
|
2.4
|
0
|
2.3
|
0
|
Clade C (C97ZA.012) IgG2 at Week 52 |
2.3
|
0
|
0
|
4.9
|
7.7
|
0
|
7.9
|
0
|
Clade C (C97ZA.012) IgG3 at Week 28 |
44.7
|
29.3
|
10.9
|
47.7
|
29.3
|
20.5
|
25.0
|
0
|
Clade C (C97ZA.012) IgG3 at Week 52 |
43.2
|
42.1
|
7.1
|
51.2
|
35.9
|
15.4
|
43.2
|
0
|
Clade C (C97ZA.012) IgG3 at Week 96 |
12.2
|
8.3
|
4.0
|
4.5
|
13.6
|
8.3
|
16.7
|
|
Clade C (C97ZA.012) IgG4 at Week 28 |
0
|
0
|
0
|
4.4
|
0
|
0
|
0
|
0
|
Clade C (C97ZA.012) IgG4 at Week 52 |
2.3
|
2.6
|
0
|
7.3
|
0
|
0
|
5.3
|
0
|
Title | Percentage of Responders for Env ELISA Including Consensus C and Mos1 Antigens |
---|---|
Description | The response was defined as post-baseline value >LLOQ if baseline <LLOQ or missing or defined as post-baseline value >3-fold increase from baseline if baseline >=LLOQ. The LLOQ for this assay is a 50 percent (%) inhibitory concentration (IC50) of 20 (fold-dilution). The lower limits of quantification (LLOQs) for this assay were 625 and 78.125 EU/mL for Clade C (Con C) and Mos1 respectively. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category. |
Time Frame | Week 28, 52 and 96 |
Outcome Measure Data
Analysis Population Description |
---|
PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points. |
Arm/Group Title | Group 1: Ad26/Ad26 + gp140 High Dose (HD) | Group 2: Ad26/Ad26 + gp140 Low Dose (LD) | Group 3: Ad26/Ad26 | Group 4: Ad26/MVA + gp140 HD | Group 5: Ad26/ MVA + gp140 LD | Group 6: Ad26/MVA | Group 7: Ad26/ gp140 HD | Group 8: Placebo/ Placebo |
---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48. |
Measure Participants | 49 | 41 | 46 | 44 | 44 | 42 | 44 | 46 |
Consensus C (Con C) at Week 28 |
100
|
100.0
|
100.0
|
95.5
|
100.0
|
100.0
|
97.7
|
6.5
|
Consensus C (Con C) at Week 52 |
100.0
|
100.0
|
100.0
|
95.1
|
100.0
|
100.0
|
97.4
|
2.4
|
Mos1 at Week 28 |
100.0
|
100.0
|
100.0
|
97.7
|
100.0
|
100.0
|
97.7
|
4.3
|
Mos1 at Week 52 |
100.0
|
100.0
|
100.0
|
97.5
|
100.0
|
100.0
|
100.0
|
0
|
Mos1 at Week 96 |
100.0
|
100.0
|
100.0
|
97.4
|
100.0
|
100.0
|
97.1
|
0
|
Title | Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody |
---|---|
Description | The functionality of vaccine-induced antibody responses was investigated by the determination of ADCP. The response was defined as post-baseline value > limit of detection (LOD) if baseline <LOD or missing or defined as post-baseline value >3-fold increase from baseline if baseline >=LOD. The lower limits of detection (LODs) for this assay were 5.16, 6.43, 6.49, 4.32 and 4.28 (phagocytic score) for Clade A (92UG037.1), Clade B (1990a), Clade C (Con C), Clade C (C97ZA.012), and Mos1, respectively. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category of Clade A, B, C and Mos 1. |
Time Frame | Week 16, 26, 28, 52, 78, and 96 |
Outcome Measure Data
Analysis Population Description |
---|
PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points. |
Arm/Group Title | Group 1: Ad26/Ad26 + gp140 High Dose (HD) | Group 2: Ad26/Ad26 + gp140 Low Dose (LD) | Group 3: Ad26/Ad26 | Group 4: Ad26/MVA + gp140 HD | Group 5: Ad26/ MVA + gp140 LD | Group 6: Ad26/MVA | Group 7: Ad26/ gp140 HD | Group 8: Placebo/ Placebo |
---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48. |
Measure Participants | 47 | 41 | 46 | 45 | 42 | 42 | 44 | 46 |
Clade A (92UG037.1) at Week 16 |
20.0
|
20.0
|
10.0
|
66.7
|
0
|
0
|
0
|
0
|
Clade A (92UG037.1) at Week 28 |
36.2
|
29.3
|
6.5
|
46.7
|
21.4
|
22.5
|
9.1
|
0
|
Clade B (1990a) at Week 16 |
50.0
|
50.0
|
30.0
|
66.7
|
37.5
|
16.7
|
33.3
|
0
|
Clade B (1990a) at Week 28 |
78.7
|
53.7
|
37.0
|
71.1
|
61.9
|
72.5
|
36.4
|
0
|
Clade C (Con C) at Week 16 |
30.0
|
30.0
|
0
|
55.6
|
37.5
|
0
|
11.1
|
0
|
Clade C (Con C) at Week 28 |
55.3
|
39.0
|
41.3
|
53.3
|
45.2
|
47.5
|
43.2
|
8.7
|
Clade C (C97ZA.012) at Week 16 |
20.0
|
40.0
|
30.0
|
44.4
|
12.5
|
0
|
11.1
|
0
|
Clade C (C97ZA.012) at Week 26 |
93.5
|
|||||||
Clade C (C97ZA.012) at Week 28 |
72.3
|
53.7
|
19.6
|
57.8
|
50.0
|
37.5
|
45.5
|
0
|
Clade C (C97ZA.012) at Week 52 |
80.0
|
64.1
|
23.8
|
70.7
|
60.0
|
21.4
|
71.1
|
0
|
Clade C (C97ZA.012) at Week 78 |
29.5
|
15.4
|
||||||
Clade C (C97ZA.012) at Week 96 |
9.5
|
10.5
|
0
|
18.2
|
4.2
|
0
|
12.5
|
|
Mos1 at Week 16 |
90.0
|
90.0
|
70.0
|
77.8
|
100.0
|
83.3
|
88.9
|
0
|
Mos1 at Week 28 |
95.7
|
87.8
|
84.8
|
93.3
|
92.9
|
92.5
|
86.4
|
0
|
Title | Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb) |
---|---|
Description | The functionality of vaccine-induced antibody responses was investigated by the determination of nAb activity in a virus neutralization assay (VNA) using TZM-bl cells and Env-pseudotyped viruses. The response was defined as post-baseline value >LLOQ. The LLOQ for this assay is an inhibitory concentration (IC50) of 20 (fold-dilution). Data reported for the responses against Tier 1 HIV strain Clade C (MW965.26) was reported. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category. |
Time Frame | Week 28 and 52 |
Outcome Measure Data
Analysis Population Description |
---|
PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points. |
Arm/Group Title | Group 1: Ad26/Ad26 + gp140 High Dose (HD) | Group 2: Ad26/Ad26 + gp140 Low Dose (LD) | Group 3: Ad26/Ad26 | Group 4: Ad26/MVA + gp140 HD | Group 5: Ad26/ MVA + gp140 LD | Group 6: Ad26/MVA | Group 7: Ad26/ gp140 HD | Group 8: Placebo/ Placebo |
---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48. |
Measure Participants | 48 | 41 | 46 | 45 | 44 | 42 | 44 | 46 |
Clade C (MW965.26) Tier 1 at Week 28 |
54.2
|
41.5
|
21.7
|
51.1
|
43.2
|
36.6
|
29.5
|
2.2
|
Clade C (MW965.26) Tier 1 at Week 52 |
75.6
|
65.8
|
11.9
|
73.2
|
52.5
|
45.2
|
68.4
|
2.4
|
Title | Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody |
---|---|
Description | The human immunodeficiency virus (HIV)-1 BAMA employs flow-cytometric-based technology that also utilizes antibody and antigen interactions to test for the presence of specific antibodies in an unknown sample with the added advantage of multiplexing the antigens of interest. Positive and negative control standards were run with each assay to ensure specificity. The positivity threshold was determined per antigen based on the plus (+) 3 standard deviation (SD) on the non-specific background. Sample values had to be greater than or equal to this value and had to be 3-fold over the baseline values with a minimum median fluorescent intensities (MFI) value of 100. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category. |
Time Frame | Week 16, 28, 52, 78, and 96 |
Outcome Measure Data
Analysis Population Description |
---|
PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points. |
Arm/Group Title | Group 1: Ad26/Ad26 + gp140 High Dose (HD) | Group 2: Ad26/Ad26 + gp140 Low Dose (LD) | Group 3: Ad26/Ad26 | Group 4: Ad26/MVA + gp140 HD | Group 5: Ad26/ MVA + gp140 LD | Group 6: Ad26/MVA | Group 7: Ad26/ gp140 HD | Group 8: Placebo/ Placebo |
---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48. |
Measure Participants | 48 | 40 | 46 | 44 | 44 | 44 | 43 | 45 |
HIV ENV Con S gp140 CFI(Clade M)IgG1 Ab Week(W)16 |
76.6
|
|||||||
HIV ENV Con S gp140 CFI (Clade M) IgG1 Ab at W28 |
95.8
|
94.6
|
76.1
|
90.9
|
97.6
|
95.1
|
88.4
|
0
|
HIV ENV Con S gp140 CFI (Clade M) IgG1 Ab at W52 |
95.6
|
97.1
|
61.9
|
92.5
|
100.0
|
80.5
|
94.4
|
0
|
HIV ENV Con 6 gp120/B (Clade M) IgG1 Ab at W16 |
14.9
|
|||||||
HIV ENV Con 6 gp120/B (Clade M) IgG1 Ab at W28 |
60.4
|
40.5
|
15.2
|
59.1
|
39.0
|
39.0
|
23.3
|
0
|
HIV ENV Con 6 gp120/B (Clade M) IgG1 Ab at W52 |
60.0
|
44.1
|
11.9
|
62.5
|
35.1
|
19.5
|
22.2
|
0
|
HIV ENV gp41 IgG1 Ab at W16 |
59.6
|
|||||||
HIV ENV gp41 IgG1 Ab at W28 |
95.8
|
94.6
|
78.3
|
90.9
|
97.6
|
82.9
|
95.3
|
0
|
HIV ENV gp41 IgG1 Ab at W52 |
95.6
|
97.1
|
61.9
|
92.5
|
97.3
|
68.3
|
97.2
|
0
|
HIV ENV 1086C_D7 gp120 (Clade C) IgG1 Ab at W16 |
40.4
|
|||||||
HIV ENV 1086C_D7 gp120 (Clade C) IgG1 Ab at W28 |
85.4
|
70.3
|
56.5
|
79.5
|
87.8
|
70.7
|
72.1
|
0
|
HIV ENV 1086C_D7 gp120 (Clade C) IgG1 Ab at W52 |
80.0
|
79.4
|
35.7
|
82.5
|
83.8
|
46.3
|
83.3
|
0
|
HIV ENV 1086C gp140 (Clade C) IgG1 Ab at W16 |
74.5
|
|||||||
HIV ENV 1086C gp140 (Clade C) IgG1 Ab at W28 |
93.8
|
94.6
|
76.1
|
90.9
|
100.0
|
100.0
|
86.0
|
0
|
HIV ENV 1086C gp140 (Clade C) IgG1 Ab at W52 |
95.6
|
97.1
|
76.2
|
92.5
|
97.3
|
90.2
|
94.4
|
0
|
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG1 Ab at W16 |
6.4
|
|||||||
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG1 Ab at W28 |
16.7
|
10.8
|
2.2
|
18.2
|
19.5
|
4.9
|
7.0
|
0
|
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG1 Ab at W52 |
20.0
|
8.8
|
4.8
|
25.0
|
13.5
|
9.8
|
13.9
|
0
|
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG1 Ab at W16 |
14.9
|
|||||||
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG1 Ab at W28 |
29.2
|
27.0
|
10.9
|
20.5
|
22.0
|
7.3
|
7.0
|
0
|
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG1 Ab at W52 |
13.3
|
14.7
|
9.5
|
22.5
|
13.5
|
0
|
13.9
|
2.4
|
HIV ENV Con S gp140 CFI (Clade M) IgG2 Ab at W16 |
0
|
|||||||
HIV ENV Con S gp140 CFI (Clade M) IgG2 Ab at W28 |
2.1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
HIV ENV Con S gp140 CFI (Clade M) IgG2 Ab at W52 |
2.2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
HIV ENV Con 6 gp120/B (Clade M) IgG2 Ab at W16 |
0
|
|||||||
HIV ENV Con 6 gp120/B (Clade M) IgG2 Ab at W28 |
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
HIV ENV Con 6 gp120/B (Clade M) IgG2 Ab at W52 |
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
HIV ENV gp41 IgG2 Ab at W16 |
0
|
|||||||
HIV ENV gp41 IgG2 Ab at W28 |
2.1
|
0
|
0
|
2.3
|
2.4
|
0
|
0
|
0
|
HIV ENV gp41 IgG2 Ab at W52 |
0
|
2.7
|
0
|
5.0
|
0
|
0
|
0
|
0
|
HIV ENV 1086C_D7 gp120 (Clade C) IgG2 Ab at W16 |
2.1
|
|||||||
HIV ENV 1086C_D7 gp120 (Clade C) IgG2 Ab at W28 |
2.1
|
0
|
0
|
2.3
|
0
|
0
|
0
|
0
|
HIV ENV 1086C_D7 gp120 (Clade C) IgG2 Ab at W52 |
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
HIV ENV 1086C gp140 (Clade C) IgG2 Ab at W16 |
2.1
|
|||||||
HIV ENV 1086C gp140 (Clade C) IgG2 Ab at W28 |
2.1
|
0
|
0
|
2.3
|
0
|
0
|
0
|
0
|
HIV ENV 1086C gp140 (Clade C) IgG2 Ab at W52 |
2.2
|
0
|
0
|
2.5
|
2.7
|
0
|
0
|
0
|
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG2 Ab at W16 |
0
|
|||||||
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG2 Ab at W28 |
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG2 Ab at W52 |
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG2 Ab at W16 |
0
|
|||||||
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG2 Ab at W28 |
0
|
2.5
|
0
|
0
|
2.4
|
0
|
0
|
0
|
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG2 Ab at W52 |
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
HIV ENV Con S gp140 CFI (Clade M) IgG3 Ab at W16 |
61.7
|
|||||||
HIV ENV Con S gp140 CFI (Clade M) IgG3 Ab at W28 |
75.0
|
47.5
|
34.8
|
76.7
|
79.1
|
58.5
|
67.4
|
0
|
HIV ENV Con S gp140 CFI (Clade M) IgG3 Ab at W52 |
76.7
|
59.5
|
56.1
|
78.9
|
82.1
|
48.8
|
81.1
|
7.7
|
HIV ENV Con S gp140 CFI (Clade M) IgG3 Ab at W78 |
53.5
|
28.9
|
||||||
HIV ENV Con S gp140 CFI (Clade M) IgG3 Ab at W96 |
48.8
|
34.3
|
||||||
HIV ENV Con 6 gp120/B (Clade M) IgG3 Ab at W16 |
31.9
|
|||||||
HIV ENV Con 6 gp120/B (Clade M) IgG3 Ab at W28 |
31.3
|
22.5
|
10.9
|
32.6
|
23.3
|
22.0
|
11.6
|
0
|
HIV ENV Con 6 gp120/B (Clade M) IgG3 Ab at W52 |
48.8
|
27.0
|
17.1
|
47.4
|
46.2
|
31.7
|
24.3
|
2.6
|
HIV ENV Con 6 gp120/B (Clade M) IgG3 Ab at W78 |
14.0
|
7.9
|
||||||
HIV ENV Con 6 gp120/B (Clade M) IgG3 Ab at W96 |
17.1
|
8.6
|
||||||
HIV ENV gp41 IgG3 Ab at W16 |
25.5
|
|||||||
HIV ENV gp41 IgG3 Ab at W28 |
52.1
|
45.0
|
13.0
|
55.8
|
58.1
|
26.8
|
46.5
|
0
|
43HIV ENV gp41 IgG3 Ab at W52 |
67.4
|
54.1
|
14.6
|
73.7
|
79.5
|
26.8
|
67.6
|
7.7
|
HIV ENV gp41 IgG3 Ab at W78 |
34.9
|
23.7
|
||||||
HIV ENV gp41 IgG3 Ab at W96 |
31.7
|
22.9
|
||||||
HIV ENV 1086C_D7 gp120 (Clade C) IgG3 Ab at W16 |
68.1
|
|||||||
HIV ENV 1086C_D7 gp120 (Clade C) IgG3 Ab at W28 |
66.7
|
50.0
|
39.1
|
65.1
|
65.1
|
58.5
|
53.5
|
0
|
HIV ENV 1086C_D7 gp120 (Clade C) IgG3 Ab at W52 |
76.7
|
67.6
|
51.2
|
78.9
|
82.1
|
58.5
|
75.7
|
2.6
|
HIV ENV 1086C_D7 gp120 (Clade C) IgG3 Ab at W78 |
53.5
|
39.5
|
||||||
HIV ENV 1086C_D7 gp120 (Clade C) IgG3 Ab at W96 |
48.8
|
37.1
|
||||||
HIV ENV 1086C gp140 (Clade C) IgG3 Ab at W16 |
74.5
|
|||||||
HIV ENV 1086C gp140 (Clade C) IgG3 Ab at W28 |
83.3
|
60.0
|
67.4
|
86.0
|
86.0
|
75.6
|
76.7
|
0
|
HIV ENV 1086C gp140 (Clade C) IgG3 Ab at W52 |
81.4
|
70.3
|
65.9
|
86.8
|
87.2
|
61.0
|
83.8
|
2.6
|
HIV ENV 1086C gp140 (Clade C) IgG3 Ab at W78 |
55.8
|
36.8
|
||||||
HIV ENV 1086C gp140 (Clade C) IgG3 Ab at W96 |
46.3
|
31.4
|
||||||
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG3 Ab at W16 |
12.8
|
|||||||
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG3 Ab at W28 |
18.8
|
12.5
|
6.5
|
23.3
|
16.3
|
14.6
|
16.3
|
0
|
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG3 Ab at W52 |
25.6
|
10.8
|
9.8
|
28.9
|
15.4
|
9.8
|
16.2
|
2.6
|
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG3 Ab at W78 |
4.7
|
2.6
|
||||||
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG3 Ab at W96 |
9.8
|
8.6
|
||||||
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG3 Ab at W16 |
14.9
|
|||||||
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG3 Ab at W28 |
12.5
|
12.5
|
11.1
|
18.6
|
11.6
|
12.2
|
7.0
|
0
|
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG3 Ab at W52 |
18.6
|
10.8
|
5.0
|
28.9
|
7.7
|
7.5
|
10.8
|
2.6
|
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG3 Ab at W78 |
2.3
|
2.6
|
||||||
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG3 Ab at W96 |
2.4
|
2.9
|
||||||
HIV ENV Con S gp140 CFI (Clade M) IgG4 Ab at W16 |
10.4
|
|||||||
HIV ENV Con S gp140 CFI (Clade M) IgG4 Ab at W28 |
12.5
|
10.0
|
13.0
|
9.3
|
9.1
|
7.3
|
16.3
|
0
|
HIV ENV Con S gp140 CFI (Clade M) IgG4 Ab at W52 |
40.0
|
29.7
|
19.0
|
28.9
|
20.0
|
12.2
|
35.1
|
0
|
HIV ENV Con 6 gp120/B (Clade M) IgG4 Ab at W16 |
0
|
|||||||
HIV ENV Con 6 gp120/B (Clade M) IgG4 Ab at W28 |
2.1
|
2.5
|
0
|
4.7
|
0
|
0
|
7.0
|
0
|
HIV ENV Con 6 gp120/B (Clade M) IgG4 Ab at W52 |
15.6
|
10.8
|
2.4
|
18.4
|
5.0
|
0
|
8.1
|
0
|
HIV ENV gp41 IgG4 Ab at W16 |
10.4
|
|||||||
HIV ENV gp41 IgG4 Ab at W28 |
33.3
|
15.0
|
13.0
|
25.6
|
20.5
|
7.3
|
34.9
|
2.2
|
HIV ENV gp41 IgG4 Ab at W52 |
66.7
|
56.8
|
16.7
|
52.6
|
45.0
|
7.3
|
62.2
|
7.3
|
HIV ENV 1086C_D7 gp120 (Clade C) IgG4 Ab at W16 |
10.4
|
|||||||
HIV ENV 1086C_D7 gp120 (Clade C) IgG4 Ab at W28 |
14.6
|
7.5
|
6.5
|
9.3
|
6.8
|
9.8
|
14.0
|
0
|
HIV ENV 1086C_D7 gp120 (Clade C) IgG4 Ab at W52 |
31.1
|
21.6
|
9.5
|
28.9
|
20.0
|
12.2
|
27.0
|
0
|
HIV ENV 1086C gp140 (Clade C) IgG4 Ab at W16 |
12.5
|
|||||||
HIV ENV 1086C gp140 (Clade C) IgG4 Ab at W28 |
18.8
|
12.5
|
10.9
|
9.3
|
13.6
|
9.8
|
16.3
|
0
|
HIV ENV 1086C gp140 (Clade C) IgG4 Ab at W52 |
46.7
|
35.1
|
16.7
|
28.9
|
40.0
|
22.0
|
37.8
|
0
|
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG4 Ab at W16 |
0
|
|||||||
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG4 Ab at W28 |
2.1
|
2.5
|
0
|
4.7
|
2.3
|
2.4
|
2.3
|
0
|
HIV ENV 1086C_V1V2 gp70 (Clade C) IgG4 Ab at W52 |
2.2
|
5.4
|
4.8
|
2.6
|
2.5
|
2.4
|
5.4
|
0
|
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG4 Ab at W16 |
0
|
|||||||
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG4 Ab at W28 |
0
|
0
|
0
|
2.3
|
0
|
0
|
0
|
0
|
HIV ENV gp70_B.CaseA_V1V2 (Clade B) IgG4 Ab at W52 |
0
|
2.7
|
0
|
5.3
|
2.5
|
2.4
|
2.7
|
0
|
HIV ENV Con S gp140 CFI (Clade M) IgA Ab at W16 |
60.0
|
|||||||
HIV ENV Con S gp140 CFI (Clade M) IgA Ab at W28 |
76.9
|
87.1
|
77.8
|
82.9
|
85.3
|
78.9
|
83.8
|
0
|
HIV ENV Con S gp140 CFI (Clade M) IgA Ab at W52 |
77.1
|
92.0
|
61.3
|
84.6
|
69.2
|
68.8
|
86.2
|
0
|
HIV ENV Con 6 gp120/B (Clade M) IgA Ab at W16 |
52.5
|
|||||||
HIV ENV Con 6 gp120/B (Clade M) IgA Ab at W28 |
59.0
|
45.2
|
44.4
|
45.7
|
47.1
|
39.5
|
48.6
|
0
|
HIV ENV Con 6 gp120/B (Clade M) IgA Ab at W52 |
60.0
|
40.0
|
45.2
|
50.0
|
42.3
|
43.8
|
55.2
|
0
|
HIV ENV 1086C_D7 gp120 (Clade C) IgA Ab at W16 |
67.5
|
|||||||
HIV ENV 1086C_D7 gp120 (Clade C) IgA Ab at W28 |
71.8
|
77.4
|
61.1
|
74.3
|
79.4
|
68.4
|
78.4
|
0
|
HIV ENV 1086C_D7 gp120 (Clade C) IgA Ab at W52 |
74.3
|
68.0
|
41.9
|
76.9
|
73.1
|
59.4
|
65.5
|
0
|
HIV ENV ConA1 gp140 (Clade A) IgA Ab at W16 |
30.0
|
|||||||
HIV ENV ConA1 gp140 (Clade A) IgA Ab at W28 |
46.2
|
51.6
|
41.7
|
59.24
|
47.1
|
36.8
|
62.2
|
0
|
HIV ENV 00MSA gp140 (Clade A) IgA Ab at W16 |
45.0
|
|||||||
HIV ENV 00MSA gp140 (Clade A) IgA Ab at W28 |
56.4
|
64.5
|
41.7
|
51.4
|
52.9
|
47.4
|
48.6
|
0
|
HIV ENV gp41 IgA Ab at W16 |
10.0
|
|||||||
HIV ENV gp41 IgA Ab at W28 |
48.7
|
29.0
|
11.1
|
42.9
|
32.4
|
7.9
|
37.8
|
2.6
|
HIV ENV gp41 IgA Ab at W52 |
48.6
|
36.0
|
9.7
|
53.8
|
46.2
|
12.5
|
58.6
|
0
|
Clade A (51802) IgG-t Ab at W16 |
72.7
|
|||||||
Clade A (51802) IgG-t Ab at W28 |
91.3
|
94.3
|
88.4
|
87.5
|
85.7
|
94.7
|
85.7
|
0
|
Clade A (51802) IgG-t Ab at W52 |
100.0
|
100.0
|
87.2
|
97.1
|
100.0
|
86.8
|
90.9
|
5.6
|
Clade A (51802) IgG-t Ab at W78 |
79.5
|
81.8
|
||||||
Clade A (51802) IgG-t Ab at W96 |
68.4
|
74.2
|
||||||
Clade AE (254008) IgG-t Ab at W16 |
84.1
|
|||||||
Clade AE (254008) IgG-t Ab at W28 |
89.1
|
97.1
|
88.4
|
85.0
|
85.7
|
97.4
|
88.1
|
0
|
Clade AE (254008) IgG-t Ab at W52 |
100.0
|
100.0
|
87.2
|
97.1
|
100.0
|
92.1
|
93.9
|
0
|
Clade AE (254008) IgG-t Ab at W78 |
97.4
|
97.0
|
||||||
Clade AE (254008) IgG-t Ab at W96 |
94.7
|
90.3
|
||||||
Clade AE (A244) IgG-t Ab at W16 |
75.0
|
|||||||
Clade AE (A244) IgG-t Ab at W28 |
91.3
|
91.4
|
81.4
|
90.0
|
85.7
|
94.7
|
88.1
|
0
|
Clade AE (A244) IgG-t Ab at W52 |
100.0
|
100.0
|
89.7
|
91.2
|
97.0
|
89.5
|
90.9
|
0
|
Clade AE (A244) IgG-t Ab at W78 |
84.6
|
84.8
|
||||||
Clade AE (A244) IgG-t Ab at W96 |
71.1
|
71.0
|
||||||
Clade B (B.6240) IgG-t Ab at W16 |
86.4
|
|||||||
Clade B (B.6240) IgG-t Ab at W28 |
95.7
|
97.1
|
97.7
|
92.5
|
85.7
|
97.4
|
90.5
|
0
|
Clade B (B.6240) IgG-t Ab at W52 |
100.0
|
100.0
|
92.3
|
94.1
|
100.0
|
97.4
|
93.9
|
0
|
Clade B (B.6240) IgG-t Ab at W78 |
84.6
|
93.9
|
||||||
Clade B (B.6240) IgG-t Ab at W96 |
86.8
|
93.5
|
||||||
Clade B (BORI) IgG-t Ab at W16 |
95.5
|
|||||||
Clade B (BORI) IgG-t Ab at W28 |
95.7
|
97.1
|
93.0
|
90.0
|
88.6
|
97.4
|
90.5
|
0
|
Clade B (BORI) IgG-t Ab at Week 52 |
100.0
|
100.0
|
97.4
|
97.1
|
100.0
|
97.4
|
93.9
|
0
|
Clade B (BORI) IgG-t Ab at W78 |
84.6
|
84.8
|
||||||
Clade B (BORI) IgG-t Ab at W96 |
73.7
|
74.2
|
||||||
Clade B (TT31P) gp120 IgG-t Ab at W16 |
90.9
|
|||||||
Clade B (TT31P) gp120 IgG-t Ab at W28 |
95.7
|
91.4
|
90.7
|
92.5
|
88.6
|
100.0
|
88.1
|
0
|
Clade B (TT31P) gp120 IgG-t Ab at W52 |
100.0
|
100.0
|
94.9
|
94.1
|
100.0
|
100.0
|
90.9
|
0
|
Clade B (TT31P) gp120 IgG-t Ab at W78 |
87.2
|
93.9
|
||||||
Clade B (TT31P) gp120 IgG-t Ab at W96 |
86.8
|
87.1
|
||||||
Clade BC (CNE20) IgG-t Ab at W16 |
90.9
|
|||||||
Clade BC (CNE20) IgG-t Ab at W28 |
93.5
|
94.3
|
90.7
|
90.0
|
88.6
|
97.4
|
92.9
|
0
|
Clade BC (CNE20) IgG-t Ab at W52 |
100.0
|
100.0
|
97.4
|
97.1
|
100.0
|
94.7
|
93.9
|
0
|
Clade BC (CNE20) IgG-t Ab at W78 |
84.6
|
93.9
|
||||||
Clade BC (CNE20) IgG-t Ab at W96 |
78.9
|
87.1
|
||||||
Clade BC(BJOX002) IgG-t Ab at W16 |
75.0
|
|||||||
Clade BC(BJOX002) IgG-t Ab at W28 |
87.0
|
94.3
|
88.4
|
85.0
|
82.9
|
89.5
|
90.5
|
0
|
Clade BC(BJOX002) IgG-t Ab at W52 |
100.0
|
100.0
|
89.7
|
97.1
|
97.0
|
94.7
|
93.9
|
0
|
Clade BC(BJOX002) IgG-t Ab at W78 |
74.4
|
75.8
|
||||||
Clade BC(BJOX002) IgG-t Ab at W96 |
68.4
|
74.2
|
||||||
Clade C(1086C_D7) IgG-t Ab at W16 |
97.7
|
|||||||
Clade C(1086C_D7) IgG-t Ab at W28 |
100.0
|
97.1
|
100.0
|
97.5
|
88.6
|
100.0
|
90.75
|
0
|
Clade C(1086C_D7) IgG-t Ab at W52 |
100.0
|
100.0
|
100.0
|
97.1
|
100.0
|
100.0
|
97.0
|
0
|
Clade C(1086C_D7) IgG-t Ab at W78 |
100.0
|
100.0
|
||||||
Clade C(1086C_D7) IgG-t Ab at Week 96 |
97.4
|
96.8
|
||||||
B Clade M (Con 6) IgG-t Ab at W16 |
97.7
|
|||||||
B Clade M (Con 6) IgG-t Ab at W28 |
97.8
|
97.1
|
97.7
|
92.5
|
88.6
|
100.0
|
92.9
|
0
|
B Clade M (Con 6) IgG-t Ab at W52 |
100.0
|
100.0
|
97.4
|
97.1
|
100.0
|
100.0
|
97.0
|
0
|
B Clade M (Con 6) IgG-t Ab at W78 |
97.4
|
97.0
|
||||||
B Clade M (Con 6) IgG-t Ab at W96 |
92.1
|
93.5
|
||||||
Clade B (SC42261) IgG-t Ab at W16 |
95.5
|
|||||||
Clade B (SC42261) IgG-t Ab at W28 |
97.8
|
97.1
|
100.0
|
95.0
|
88.6
|
100.0
|
95.2
|
0
|
Clade B (SC42261) IgG-t Ab at W52 |
100.0
|
100.0
|
100.0
|
97.1
|
100.0
|
100.0
|
97.0
|
0
|
Clade B (SC42261) IgG-t Ab at W78 |
92.3
|
97.0
|
||||||
Clade B (SC42261) IgG-t Ab at W96 |
92.1
|
93.5
|
||||||
Clade C (CH505TF) IgG-t Ab at W16 |
88.6
|
|||||||
Clade C (CH505TF) IgG-t Ab at W28 |
93.5
|
97.1
|
93.0
|
92.5
|
85.7
|
97.4
|
95.2
|
0
|
Clade C (CH505TF) IgG-t Ab at W52 |
100.0
|
100.0
|
92.3
|
97.1
|
100.0
|
100.0
|
97.0
|
0
|
Clade C (CH505TF) IgG-t Ab at W78 |
84.2
|
90.9
|
||||||
Clade C (CH505TF) IgG-t Ab at W96 |
81.6
|
77.4
|
||||||
C Clade A (9004S) IgG-t Ab at W16 |
84.1
|
|||||||
C Clade A (9004S) IgG-t Ab at W28 |
91.3
|
94.3
|
90.7
|
90.0
|
85.7
|
97.4
|
88.1
|
0
|
C Clade A (9004S) IgG-t Ab at W52 |
100.0
|
100.0
|
94.9
|
100.0
|
100.0
|
100.0
|
93.9
|
0
|
C Clade A (9004S) IgG-t Ab at W78 |
87.2
|
84.8
|
||||||
C Clade A (9004S) IgG-t Ab at W96 |
86.8
|
87.1
|
||||||
C Clade B (RHPA) IgG-t Ab at W16 |
97.7
|
|||||||
C Clade B (RHPA) IgG-t Ab at W28 |
97.8
|
97.1
|
100.0
|
92.5
|
88.6
|
100.0
|
95.2
|
0
|
C Clade B (RHPA) IgG-t Ab at Week 52 |
100.0
|
100.0
|
100.0
|
97.1
|
100.0
|
100.0
|
97.0
|
2.8
|
C Clade B (RHPA) IgG-t Ab at W78 |
92.3
|
97.0
|
||||||
C Clade B (RHPA) IgG-t Ab at W96 |
92.1
|
93.5
|
||||||
C Clade B (WITO) IgG-t Ab at W16 |
93.2
|
|||||||
C Clade B (WITO) IgG-t Ab at W28 |
97.8
|
97.1
|
97.7
|
92.5
|
88.6
|
100.0
|
95.2
|
0
|
C Clade B (WITO) IgG-t Ab at W52 |
100.0
|
100.0
|
97.4
|
97.1
|
100.0
|
100.0
|
97.0
|
0
|
C Clade B (WITO) IgG-t Ab at W78 |
87.2
|
97.0
|
||||||
C Clade B (WITO) IgG-t Ab at W96 |
92.1
|
93.5
|
||||||
C Clade C (1086C) IgG-t Ab at W16 |
97.7
|
|||||||
C Clade C (1086C) IgG-t Ab at W28 |
100.0
|
97.1
|
100.0
|
97.5
|
88.6
|
100.0
|
97.6
|
2.5
|
C Clade C (1086C) IgG-t Ab at W52 |
100.0
|
100.0
|
100.0
|
97.1
|
100.0
|
100.0
|
97.0
|
0
|
C Clade C (1086C) IgG-t Ab at W78 |
100.0
|
100.0
|
||||||
C Clade C (1086C) IgG-t Ab at W96 |
100.0
|
96.8
|
||||||
C Clade C (BF1266) IgG-t Ab at W16 |
93.2
|
|||||||
C Clade C (BF1266) IgG-t Ab at W28 |
95.7
|
97.1
|
97.7
|
92.5
|
88.6
|
100.0
|
92.9
|
2.5
|
C Clade C (BF1266) IgG-t Ab at W52 |
100.0
|
100.0
|
100.0
|
100.0
|
100.0
|
100.0
|
97.0
|
2.8
|
C Clade C (BF1266) IgG-t Ab at W78 |
92.3
|
100.0
|
||||||
C Clade C (BF1266) IgG-t Ab at Week 96 |
92.1
|
93.5
|
||||||
CF Clade AE (conAE) IgG-t Ab at 16 |
88.6
|
|||||||
CF Clade AE (conAE) IgG-t Ab at W28 |
95.7
|
97.1
|
93.0
|
90.0
|
85.7
|
97.4
|
95.2
|
0
|
CF Clade AE (conAE) IgG-t Ab at W52 |
100.0
|
100.0
|
92.3
|
97.1
|
100.0
|
97.4
|
97.0
|
0
|
CF Clade AE (conAE) IgG-t Ab at W78 |
92.3
|
97.0
|
||||||
CF Clade AE (conAE) IgG-t Ab at W96 |
84.2
|
87.1
|
||||||
CFI Clade M(Con S) IgG-t Ab at W16 |
97.7
|
|||||||
CFI Clade M(Con S) IgG-t Ab at W28 |
100.0
|
97.1
|
100.0
|
97.5
|
88.6
|
100.0
|
97.6
|
0
|
CFI Clade M(Con S) IgG-t Ab at W52 |
100.0
|
100.0
|
100.0
|
97.1
|
100.0
|
100.0
|
100.0
|
0
|
CFI Clade M(Con S) IgG-t Ab at W78 |
100.0
|
100.0
|
||||||
CFI Clade M(Con S) IgG-t Ab at Week 96 |
100.0
|
96.8
|
||||||
IgG-t Ab at W16 |
72.7
|
|||||||
IgG-t Ab at W28 |
95.7
|
88.6
|
79.1
|
87.5
|
85.7
|
89.5
|
90.5
|
0
|
IgG-t Ab at W52 |
100.0
|
100.0
|
89.7
|
97.1
|
97.0
|
92.1
|
97.0
|
5.6
|
IgG-t Ab at W78 |
87.2
|
81.8
|
||||||
IgG-t Ab at W96 |
81.6
|
67.7
|
||||||
Clade A (191084) IgG-t Ab at W16 |
47.7
|
|||||||
Clade A (191084) IgG-t Ab at W28 |
65.2
|
45.7
|
46.5
|
60.0
|
42.9
|
47.4
|
38.1
|
0
|
Clade A (191084) IgG-t Ab at W52 |
81.1
|
62.5
|
59.0
|
73.5
|
75.8
|
57.9
|
51.5
|
0
|
Clade A (191084) IgG-t Ab at W78 |
28.2
|
18.2
|
||||||
Clade A (191084) IgG-t Ab at W96 |
21.1
|
16.1
|
||||||
Clade AE (C2101) IgG-t Ab at W16 |
47.7
|
|||||||
Clade AE (C2101) IgG-t Ab at W28 |
58.7
|
45.7
|
48.8
|
62.5
|
48.6
|
52.6
|
28.6
|
0
|
Clade AE (C2101) IgG-t Ab at W52 |
73.0
|
59.4
|
61.5
|
79.4
|
69.7
|
55.3
|
36.4
|
2.8
|
Clade AE (C2101) IgG-t Ab at W78 |
28.2
|
30.3
|
||||||
Clade AE (C2101) IgG-t Ab at W96 |
21.1
|
32.3
|
||||||
Clade AE (CM244) IgG-t Ab at W16 |
47.7
|
|||||||
Clade AE (CM244) IgG-t Ab at W28 |
58.7
|
37.1
|
46.5
|
57.5
|
29.4
|
42.1
|
28.6
|
0
|
Clade AE (CM244) IgG-t Ab at W52 |
83.8
|
56.3
|
56.4
|
76.5
|
57.6
|
57.9
|
42.4
|
0
|
Clade AE (CM244) IgG-t Ab at W78 |
23.1
|
12.1
|
||||||
Clade AE (CM244) IgG-t Ab at W96 |
21.1
|
16.1
|
||||||
Clade B (62357.14) IgG-t Ab at W16 |
22.7
|
|||||||
Clade B (62357.14) IgG-t Ab at W28 |
41.3
|
17.1
|
16.3
|
37.5
|
20.0
|
23.7
|
19.0
|
0
|
Clade B (62357.14) IgG-t Ab at W52 |
59.5
|
34.4
|
20.5
|
61.8
|
45.5
|
26.3
|
36.4
|
0
|
Clade B (62357.14) IgG-t Ab at W78 |
20.5
|
9.1
|
||||||
Clade B (62357.14) IgG-t Ab at W96 |
10.5
|
12.9
|
||||||
Clade B (CaseA) IgG-t Ab at W16 |
59.1
|
|||||||
Clade B (CaseA) IgG-t Ab at W28 |
67.4
|
51.4
|
62.8
|
65.0
|
42.9
|
63.2
|
45.2
|
0
|
Clade B (CaseA) IgG-t Ab at W52 |
86.5
|
75.0
|
71.8
|
70.6
|
81.8
|
71.1
|
60.6
|
13.9
|
Clade B (CaseA) IgG-t Ab at W78 |
42.1
|
30.3
|
||||||
Clade B (CaseA) IgG-t Ab at W96 |
28.9
|
29.0
|
||||||
Clade B (RHPA4259) IgG-t Ab at W16 |
50.0
|
|||||||
Clade B (RHPA4259) IgG-t Ab at W28 |
69.6
|
48.6
|
51.2
|
60.0
|
47.1
|
50.0
|
35.7
|
0
|
Clade B (RHPA4259) IgG-t Ab at W52 |
83.8
|
59.4
|
59.0
|
67.6
|
75.8
|
57.9
|
48.5
|
0
|
Clade B (RHPA4259) IgG-t Ab at W78 |
33.3
|
18.2
|
||||||
Clade B (RHPA4259) IgG-t Ab at W96 |
28.9
|
22.6
|
||||||
Clade B (TT31P) gp70 IgG-t Ab at W16 |
59.1
|
|||||||
Clade B (TT31P) gp70 IgG-t Ab at W28 |
69.6
|
45.7
|
51.2
|
62.5
|
37.1
|
50.0
|
50.0
|
0
|
Clade B (TT31P) gp70 IgG-t Ab at W52 |
86.5
|
62.5
|
66.7
|
73.5
|
75.8
|
57.9
|
57.6
|
2.8
|
Clade B (TT31P) gp70 IgG-t Ab at W78 |
36.8
|
24.2
|
||||||
Clade B (TT31P) gp70 IgG-t Ab at W96 |
31.6
|
22.6
|
||||||
Clade B(700010058) IgG-t Ab at W16 |
50.0
|
|||||||
Clade B(700010058) IgG-t Ab at W28 |
60.9
|
45.7
|
53.5
|
62.5
|
37.1
|
50.0
|
26.2
|
0
|
Clade B(700010058) IgG-t Ab at W52 |
64.9
|
62.5
|
64.1
|
70.6
|
66.7
|
57.9
|
33.3
|
0
|
Clade B(700010058) IgG-t Ab at W78 |
28.2
|
30.3
|
||||||
Clade B(700010058) IgG-t Ab at W96 |
27.0
|
23.3
|
||||||
Clade BC (BJOX) IgG-t Ab at W16 |
52.3
|
|||||||
Clade BC (BJOX) IgG-t Ab at W28 |
67.4
|
48.6
|
55.8
|
62.5
|
40.0
|
47.4
|
35.7
|
0
|
Clade BC (BJOX) IgG-t Ab at W52 |
81.1
|
62.5
|
66.7
|
70.6
|
66.7
|
60.5
|
54.5
|
2.8
|
Clade BC (BJOX) IgG-t Ab at W78 |
23.1
|
18.2
|
||||||
Clade BC (BJOX) IgG-t Ab at W96 |
21.1
|
22.6
|
||||||
Clade C (96ZM651) IgG-t Ab at W16 |
13.6
|
|||||||
Clade C (96ZM651) IgG-t Ab at W28 |
28.3
|
17.1
|
4.7
|
32.5
|
20.0
|
18.4
|
14.3
|
0
|
Clade C (96ZM651) IgG-t Ab at W52 |
54.1
|
40.6
|
20.5
|
61.8
|
36.4
|
36.8
|
30.3
|
2.8
|
Clade C (96ZM651) IgG-t Ab at W78 |
10.3
|
9.1
|
||||||
Clade C (96ZM651) IgG-t Ab at W96 |
10.5
|
6.5
|
||||||
Clade C (BF1266) IgG-t Ab at W16 |
43.2
|
|||||||
Clade C (BF1266) IgG-t Ab at W28 |
58.7
|
31.4
|
30.2
|
50.0
|
34.3
|
34.2
|
31.0
|
0
|
Clade C (BF1266) IgG-t Ab at W52 |
78.4
|
43.8
|
43.6
|
70.6
|
51.5
|
42.1
|
48.5
|
0
|
Clade C (BF1266) IgG-t Ab at W78 |
17.9
|
18.2
|
||||||
Clade C (BF1266) IgG-t Ab at W96 |
18.4
|
22.6
|
||||||
Clade C (CAP210) IgG-t Ab at W16 |
34.1
|
|||||||
Clade C (CAP210) IgG-t Ab at W28 |
47.8
|
42.9
|
32.6
|
50.0
|
25.7
|
21.1
|
26.2
|
0
|
Clade C (CAP210) IgG-t Ab at W52 |
67.6
|
53.1
|
43.6
|
67.6
|
51.5
|
39.5
|
48.5
|
0
|
Clade C (CAP210) IgG-t Ab at W78 |
25.6
|
18.2
|
||||||
Clade C (CAP210) IgG-t Ab at W96 |
21.1
|
16.1
|
||||||
Clade C(Ce1086) IgG-t Ab at W16 |
47.7
|
|||||||
Clade C(Ce1086) IgG-t Ab at W28 |
65.2
|
48.6
|
55.8
|
60.0
|
41.2
|
50.0
|
35.7
|
0
|
Clade C(Ce1086) IgG-t Ab at W52 |
81.1
|
65.6
|
64.1
|
85.3
|
72.7
|
68.4
|
54.5
|
0
|
Clade C(Ce1086) IgG-t Ab at W78 |
28.2
|
18.2
|
||||||
Clade C(Ce1086) IgG-t Ab at W96 |
23.7
|
22.6
|
||||||
Clade C(TV1.21)IgG-t Ab at W16 |
56.8
|
|||||||
Clade C(TV1.21)IgG-t Ab at W28 |
78.3
|
54.3
|
48.8
|
62.5
|
48.6
|
39.5
|
50.0
|
0
|
Clade C(TV1.21)IgG-t Ab at W52 |
89.2
|
68.8
|
64.1
|
79.4
|
78.8
|
50.0
|
66.7
|
2.8
|
Clade C(TV1.21)IgG-t Ab at W78 |
38.5
|
27.3
|
||||||
Clade C(TV1.21)IgG-t Ab at W96 |
29.7
|
26.7
|
||||||
Clade C (001428)IgG-t Ab at W16 |
45.5
|
|||||||
Clade C (001428)IgG-t Ab at W28 |
56.5
|
40.0
|
37.2
|
57.5
|
28.6
|
31.6
|
35.7
|
0
|
Clade C (001428)IgG-t Ab at W52 |
81.1
|
68.8
|
53.8
|
73.5
|
66.7
|
42.1
|
57.6
|
0
|
Clade C (001428)IgG-t Ab at W78 |
35.0
|
25.0
|
||||||
Clade C (001428)IgG-t Ab at W96 |
28.2
|
26.7
|
||||||
Clade C (7060101641)IgG-t Ab at W16 |
47.7
|
|||||||
Clade C (7060101641)IgG-t Ab at W28 |
63.0
|
42.9
|
48.8
|
57.5
|
34.3
|
42.1
|
33.3
|
0
|
Clade C (7060101641)IgG-t Ab at W52 |
81.1
|
62.5
|
59.0
|
67.6
|
66.7
|
44.7
|
51.5
|
0
|
Clade C (7060101641)IgG-t Ab at W78 |
38.5
|
15.2
|
||||||
Clade C (7060101641)IgG-t Ab at W96 |
18.4
|
16.1
|
Title | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot) |
---|---|
Description | Frozen peripheral blood mononuclear cell (PBMCs) were analyzed by interferon-gamma (IFN-gamma) (ELISpot). The response was defined as post-baseline value >P95 if baseline <P95 or missing or defined as post-baseline value >3-fold increase from baseline if baseline >=P95. The threshold for ELISpot test was based on the 95th percentile (P95) from the baseline values of participants on that test in the study. Samples taken after W48 from PPI set, who missed 4th vaccine or deviated schedule were excluded. As planned, the data reported for this endpoint at specified time points only for each reported category. |
Time Frame | Week 26, 50, 78 and 96 |
Outcome Measure Data
Analysis Population Description |
---|
PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points. |
Arm/Group Title | Group 1: Ad26/Ad26 + gp140 High Dose (HD) | Group 2: Ad26/Ad26 + gp140 Low Dose (LD) | Group 3: Ad26/Ad26 | Group 4: Ad26/MVA + gp140 HD | Group 5: Ad26/ MVA + gp140 LD | Group 6: Ad26/MVA | Group 7: Ad26/ gp140 HD | Group 8: Placebo/ Placebo |
---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48. |
Measure Participants | 47 | 39 | 45 | 44 | 43 | 38 | 43 | 46 |
ENV peptide pool Mos1 at Week (W) 26 |
91.5
|
79.5
|
75.0
|
95.5
|
97.7
|
92.1
|
86.0
|
4.3
|
ENV peptide pool Mos1 at W 50 |
87.8
|
84.2
|
78.0
|
94.9
|
97.1
|
97.3
|
76.5
|
2.6
|
ENV peptide pool Mos2 at W 26 |
72.3
|
41.0
|
34.1
|
72.7
|
72.1
|
71.1
|
53.5
|
2.2
|
ENV peptide pool Mos2 at W 50 |
84.6
|
62.9
|
37.5
|
92.1
|
87.9
|
80.6
|
60.0
|
2.8
|
ENV peptide pool potential T-cell epitopes(PTE)W26 |
76.6
|
59.0
|
61.4
|
72.7
|
93.0
|
81.6
|
69.8
|
2.2
|
ENV peptide pool PTE at W 50 |
80.5
|
63.2
|
58.5
|
79.5
|
88.2
|
81.1
|
67.6
|
0
|
ENV peptide pool PTE at W 78 |
61.0
|
50.0
|
||||||
ENV peptide pool PTE at W 96 |
64.1
|
40.6
|
40.0
|
50.0
|
73.9
|
62.5
|
47.6
|
|
Gag peptide pool Mos1 at W 26 |
44.7
|
38.5
|
36.4
|
54.5
|
55.8
|
50.0
|
34.9
|
0
|
Gag peptide pool Mos1 at W 50 |
46.3
|
47.4
|
24.4
|
61.5
|
73.5
|
61.1
|
23.5
|
2.6
|
Gag peptide pool Mos2 at W 26 |
48.9
|
35.9
|
43.2
|
56.8
|
55.8
|
68.4
|
39.5
|
2.2
|
Gag peptide pool Mos2 at W 50 |
59.0
|
47.1
|
35.0
|
71.1
|
78.8
|
66.7
|
43.3
|
0
|
Gag peptide pool PTE at W 26 |
38.3
|
30.8
|
38.6
|
47.7
|
55.8
|
50.0
|
30.2
|
0
|
Gag peptide pool PTE at W 50 |
43.6
|
47.2
|
34.1
|
50.0
|
64.7
|
63.9
|
21.9
|
5.6
|
Gag peptide pool PTE at W 78 |
29.3
|
33.3
|
||||||
Gag peptide pool PTE at W 96 |
20.5
|
25.0
|
20.0
|
27.3
|
30.4
|
33.3
|
23.8
|
|
Pol peptide pool Mos1 at W 26 |
80.9
|
53.8
|
56.8
|
70.5
|
81.4
|
89.5
|
58.1
|
4.3
|
Pol peptide pool Mos1 at W 50 |
72.5
|
55.6
|
65.9
|
76.3
|
85.3
|
91.7
|
39.4
|
2.6
|
Pol peptide pool Mos2 at W 26 |
85.1
|
76.9
|
68.2
|
79.5
|
86.0
|
94.7
|
69.8
|
0
|
Pol peptide pool Mos2 at W 50 |
84.6
|
70.6
|
79.5
|
92.1
|
97.0
|
100.0
|
55.2
|
0
|
Pol peptide pool PTE at W 26 |
83.0
|
56.4
|
61.4
|
68.2
|
86.0
|
92.1
|
67.4
|
0
|
Pol peptide pool PTE at W 50 |
82.1
|
54.3
|
73.2
|
86.8
|
90.9
|
94.4
|
53.1
|
0
|
Pol peptide pool PTE at W 78 |
78.0
|
52.8
|
||||||
Pol peptide pool PTE at W 96 |
71.8
|
40.6
|
60.0
|
36.4
|
56.5
|
62.5
|
33.3
|
Adverse Events
Time Frame | Serious adverse events (SAEs) are reported for entire study period up to Week 96 and other AEs are reported for treatment period up to Week 52. | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. | |||||||||||||||
Arm/Group Title | Group 1: Ad26/Ad26 + gp140 High Dose (HD) | Group 2: Ad26/Ad26 + gp140 Low Dose (LD) | Group 3: Ad26/Ad26 | Group 4: Ad26/MVA + gp140 HD | Group 5: Ad26/ MVA + gp140 LD | Group 6: Ad26/MVA | Group 7: Ad26/ gp140 HD | Group 8: Placebo/ Placebo | ||||||||
Arm/Group Description | Participants received 5*10^10 viral particle (vp) of adenovirus serotype 26- Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) Intramuscular (IM) vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) IM high dose vaccine containing 250 microgram (mcg) of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV vaccine and gp140 DP IM low dose vaccine containing 50 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 5*10^10 vp Ad26.Mos.HIV IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 plaque-forming unit (pfu) modified Vaccinia Ankara (MVA)-Mosaic IM vaccine and gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and gp140 DP IM low dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received 10^8 pfu MVA-Mosaic IM vaccine and matched placebo IM vaccine. | Participants received 5*10^10 vp of Ad26.Mos.HIV IM vaccine at Week 0 and 12. At Week 24 and 48, participants received gp140 DP IM high dose vaccine containing 250 mcg of total glycoprotein mixed with adjuvant (aluminum phosphate). | Participants received matched placebo sterile 0.9% saline IM vaccine at Week 0, 12, 24 and 48. | ||||||||
All Cause Mortality |
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Group 1: Ad26/Ad26 + gp140 High Dose (HD) | Group 2: Ad26/Ad26 + gp140 Low Dose (LD) | Group 3: Ad26/Ad26 | Group 4: Ad26/MVA + gp140 HD | Group 5: Ad26/ MVA + gp140 LD | Group 6: Ad26/MVA | Group 7: Ad26/ gp140 HD | Group 8: Placebo/ Placebo | |||||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Serious Adverse Events |
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Group 1: Ad26/Ad26 + gp140 High Dose (HD) | Group 2: Ad26/Ad26 + gp140 Low Dose (LD) | Group 3: Ad26/Ad26 | Group 4: Ad26/MVA + gp140 HD | Group 5: Ad26/ MVA + gp140 LD | Group 6: Ad26/MVA | Group 7: Ad26/ gp140 HD | Group 8: Placebo/ Placebo | |||||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 5/50 (10%) | 2/49 (4.1%) | 3/49 (6.1%) | 4/48 (8.3%) | 4/49 (8.2%) | 5/49 (10.2%) | 2/50 (4%) | 5/49 (10.2%) | ||||||||
Cardiac disorders | ||||||||||||||||
Myocardial infarction | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 1/48 (2.1%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Gastrointestinal disorders | ||||||||||||||||
Mallory-Weiss syndrome | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
General disorders | ||||||||||||||||
Non-cardiac chest pain | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Local swelling | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Hepatobiliary disorders | ||||||||||||||||
Cholecystitis acute | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Immune system disorders | ||||||||||||||||
Hypersensitivity | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Infections and infestations | ||||||||||||||||
HIV infection | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 1/48 (2.1%) | 1/49 (2%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Pyelonephritis | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 1/48 (2.1%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Cellulitis | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Gastroenteritis | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Pharyngitis | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Pneumonia | 0/50 (0%) | 1/49 (2%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Sepsis | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Staphylococcal infection | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Tonsillitis bacterial | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Tubo-ovarian abscess | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Injury, poisoning and procedural complications | ||||||||||||||||
Stab wound | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Foot fracture | 0/50 (0%) | 1/49 (2%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Joint dislocation | 0/50 (0%) | 1/49 (2%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Lumbar vertebral fracture | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Soft tissue injury | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Musculoskeletal and connective tissue disorders | ||||||||||||||||
Arthralgia | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||
Intraductal proliferative breast lesion | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Pregnancy, puerperium and perinatal conditions | ||||||||||||||||
Abortion spontaneous | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Blighted ovum | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Complication of pregnancy | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Foetal death | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Psychiatric disorders | ||||||||||||||||
Adjustment disorder | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Anxiety | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Depression | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Generalised anxiety disorder | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 1/48 (2.1%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Major depression | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 1/48 (2.1%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Social circumstances | ||||||||||||||||
Pregnancy of partner | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Other (Not Including Serious) Adverse Events |
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Group 1: Ad26/Ad26 + gp140 High Dose (HD) | Group 2: Ad26/Ad26 + gp140 Low Dose (LD) | Group 3: Ad26/Ad26 | Group 4: Ad26/MVA + gp140 HD | Group 5: Ad26/ MVA + gp140 LD | Group 6: Ad26/MVA | Group 7: Ad26/ gp140 HD | Group 8: Placebo/ Placebo | |||||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 50/50 (100%) | 48/49 (98%) | 48/49 (98%) | 47/48 (97.9%) | 47/49 (95.9%) | 46/49 (93.9%) | 47/50 (94%) | 46/49 (93.9%) | ||||||||
Blood and lymphatic system disorders | ||||||||||||||||
Anaemia | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Hypochromic anaemia | 0/50 (0%) | 1/49 (2%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Leukopenia | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Lymphadenopathy | 0/50 (0%) | 1/49 (2%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 2/49 (4.1%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Neutropenia | 1/50 (2%) | 2/49 (4.1%) | 3/49 (6.1%) | 1/48 (2.1%) | 2/49 (4.1%) | 2/49 (4.1%) | 4/50 (8%) | 1/49 (2%) | ||||||||
Cardiac disorders | ||||||||||||||||
Atrioventricular block first degree | 0/50 (0%) | 1/49 (2%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Bundle branch block right | 0/50 (0%) | 1/49 (2%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Conduction disorder | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Palpitations | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 1/50 (2%) | 1/49 (2%) | ||||||||
Tachycardia | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Ear and labyrinth disorders | ||||||||||||||||
Deafness unilateral | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Ear pain | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 1/48 (2.1%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Vertigo | 1/50 (2%) | 1/49 (2%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Endocrine disorders | ||||||||||||||||
Thyroid mass | 0/50 (0%) | 1/49 (2%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Eye disorders | ||||||||||||||||
Blepharitis | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 1/48 (2.1%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Conjunctivitis allergic | 0/50 (0%) | 1/49 (2%) | 0/49 (0%) | 1/48 (2.1%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Eye irritation | 0/50 (0%) | 1/49 (2%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Eye pain | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 2/49 (4.1%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Eye swelling | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Eyelid pain | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Hypermetropia | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 1/48 (2.1%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Ocular discomfort | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 1/48 (2.1%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Photophobia | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Gastrointestinal disorders | ||||||||||||||||
Abdominal discomfort | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Abdominal distension | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Abdominal pain | 0/50 (0%) | 1/49 (2%) | 1/49 (2%) | 1/48 (2.1%) | 2/49 (4.1%) | 2/49 (4.1%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Abdominal pain lower | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 2/48 (4.2%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Abdominal pain upper | 0/50 (0%) | 0/49 (0%) | 2/49 (4.1%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Abdominal tenderness | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Constipation | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Dental caries | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 1/48 (2.1%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Diarrhoea | 4/50 (8%) | 1/49 (2%) | 2/49 (4.1%) | 2/48 (4.2%) | 3/49 (6.1%) | 0/49 (0%) | 4/50 (8%) | 0/49 (0%) | ||||||||
Dry mouth | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Dyspepsia | 0/50 (0%) | 1/49 (2%) | 2/49 (4.1%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Enteritis | 2/50 (4%) | 0/49 (0%) | 2/49 (4.1%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Flatulence | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Food poisoning | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Gastritis | 2/50 (4%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Haemorrhoids | 1/50 (2%) | 0/49 (0%) | 2/49 (4.1%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Lip blister | 0/50 (0%) | 1/49 (2%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Mouth ulceration | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Nausea | 13/50 (26%) | 10/49 (20.4%) | 15/49 (30.6%) | 15/48 (31.3%) | 10/49 (20.4%) | 12/49 (24.5%) | 11/50 (22%) | 8/49 (16.3%) | ||||||||
Peptic ulcer | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Salivary hypersecretion | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Stomatitis | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 2/49 (4.1%) | ||||||||
Tongue dry | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Tooth impacted | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 1/48 (2.1%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Toothache | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 2/49 (4.1%) | 1/50 (2%) | 1/49 (2%) | ||||||||
Vomiting | 6/50 (12%) | 1/49 (2%) | 3/49 (6.1%) | 2/48 (4.2%) | 1/49 (2%) | 3/49 (6.1%) | 0/50 (0%) | 2/49 (4.1%) | ||||||||
General disorders | ||||||||||||||||
Adverse drug reaction | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Asthenia | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Chest discomfort | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Chills | 16/50 (32%) | 12/49 (24.5%) | 21/49 (42.9%) | 18/48 (37.5%) | 12/49 (24.5%) | 18/49 (36.7%) | 12/50 (24%) | 4/49 (8.2%) | ||||||||
Face oedema | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Fatigue | 35/50 (70%) | 23/49 (46.9%) | 26/49 (53.1%) | 25/48 (52.1%) | 24/49 (49%) | 26/49 (53.1%) | 22/50 (44%) | 20/49 (40.8%) | ||||||||
Feeling cold | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Feeling hot | 0/50 (0%) | 0/49 (0%) | 2/49 (4.1%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Influenza like illness | 2/50 (4%) | 1/49 (2%) | 0/49 (0%) | 1/48 (2.1%) | 0/49 (0%) | 1/49 (2%) | 1/50 (2%) | 4/49 (8.2%) | ||||||||
Injection site bruising | 1/50 (2%) | 2/49 (4.1%) | 2/49 (4.1%) | 0/48 (0%) | 5/49 (10.2%) | 2/49 (4.1%) | 2/50 (4%) | 0/49 (0%) | ||||||||
Injection site haemorrhage | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Injection site hypersensitivity | 0/50 (0%) | 1/49 (2%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Injection site pain | 44/50 (88%) | 37/49 (75.5%) | 34/49 (69.4%) | 37/48 (77.1%) | 36/49 (73.5%) | 38/49 (77.6%) | 35/50 (70%) | 24/49 (49%) | ||||||||
Malaise | 0/50 (0%) | 1/49 (2%) | 1/49 (2%) | 3/48 (6.3%) | 1/49 (2%) | 1/49 (2%) | 1/50 (2%) | 1/49 (2%) | ||||||||
Non-cardiac chest pain | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 2/50 (4%) | 0/49 (0%) | ||||||||
Pain | 0/50 (0%) | 2/49 (4.1%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Peripheral swelling | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Pyrexia | 13/50 (26%) | 12/49 (24.5%) | 18/49 (36.7%) | 15/48 (31.3%) | 12/49 (24.5%) | 11/49 (22.4%) | 13/50 (26%) | 5/49 (10.2%) | ||||||||
Tenderness | 1/50 (2%) | 1/49 (2%) | 0/49 (0%) | 1/48 (2.1%) | 1/49 (2%) | 1/49 (2%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Axillary pain | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Induration | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Infusion site pain | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Injection site discolouration | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Injection site erythema | 12/50 (24%) | 7/49 (14.3%) | 8/49 (16.3%) | 7/48 (14.6%) | 11/49 (22.4%) | 10/49 (20.4%) | 6/50 (12%) | 3/49 (6.1%) | ||||||||
Injection site induration | 7/50 (14%) | 5/49 (10.2%) | 7/49 (14.3%) | 3/48 (6.3%) | 10/49 (20.4%) | 8/49 (16.3%) | 2/50 (4%) | 1/49 (2%) | ||||||||
Injection site oedema | 1/50 (2%) | 2/49 (4.1%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Injection site pruritus | 6/50 (12%) | 7/49 (14.3%) | 9/49 (18.4%) | 8/48 (16.7%) | 11/49 (22.4%) | 9/49 (18.4%) | 7/50 (14%) | 5/49 (10.2%) | ||||||||
Injection site rash | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Injection site swelling | 4/50 (8%) | 6/49 (12.2%) | 5/49 (10.2%) | 4/48 (8.3%) | 7/49 (14.3%) | 5/49 (10.2%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Injection site warmth | 12/50 (24%) | 10/49 (20.4%) | 8/49 (16.3%) | 8/48 (16.7%) | 10/49 (20.4%) | 8/49 (16.3%) | 6/50 (12%) | 7/49 (14.3%) | ||||||||
Swelling | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 1/48 (2.1%) | 2/49 (4.1%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Vaccination site joint discomfort | 0/50 (0%) | 1/49 (2%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Hepatobiliary disorders | ||||||||||||||||
Cholelithiasis | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Immune system disorders | ||||||||||||||||
Anaphylactic reaction | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Food allergy | 0/50 (0%) | 1/49 (2%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Hypersensitivity | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Infections and infestations | ||||||||||||||||
Abscess | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Acarodermatitis | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 1/48 (2.1%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Acute HIV infection | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 1/48 (2.1%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Acute sinusitis | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Amoebiasis | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Ascariasis | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Bacteraemia | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Bacterial vaginosis | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Body tinea | 1/50 (2%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Candida infection | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Chlamydial infection | 1/50 (2%) | 0/49 (0%) | 2/49 (4.1%) | 2/48 (4.2%) | 1/49 (2%) | 1/49 (2%) | 3/50 (6%) | 2/49 (4.1%) | ||||||||
Cystitis | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Dermatitis infected | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Ear infection | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 1/48 (2.1%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Escherichia urinary tract infection | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Fungal infection | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Fungal skin infection | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Gastroenteritis | 3/50 (6%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 2/49 (4.1%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Genital herpes simplex | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Gingivitis | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 2/50 (4%) | 2/49 (4.1%) | ||||||||
Gonorrhoea | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 1/48 (2.1%) | 1/49 (2%) | 0/49 (0%) | 1/50 (2%) | 1/49 (2%) | ||||||||
Herpes simplex | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 1/48 (2.1%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Hookworm infection | 0/50 (0%) | 1/49 (2%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Hordeolum | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Influenza | 5/50 (10%) | 3/49 (6.1%) | 5/49 (10.2%) | 5/48 (10.4%) | 5/49 (10.2%) | 1/49 (2%) | 6/50 (12%) | 5/49 (10.2%) | ||||||||
Localised infection | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 1/48 (2.1%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Malaria | 2/50 (4%) | 2/49 (4.1%) | 3/49 (6.1%) | 1/48 (2.1%) | 1/49 (2%) | 3/49 (6.1%) | 2/50 (4%) | 2/49 (4.1%) | ||||||||
Oophoritis | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Oral herpes | 0/50 (0%) | 1/49 (2%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Otitis externa | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Parasitic gastroenteritis | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Pharyngitis | 0/50 (0%) | 1/49 (2%) | 0/49 (0%) | 1/48 (2.1%) | 0/49 (0%) | 1/49 (2%) | 1/50 (2%) | 3/49 (6.1%) | ||||||||
Pharyngitis streptococcal | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Pulpitis dental | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 1/49 (2%) | ||||||||
Pyuria | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Rash pustular | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Rhinitis | 1/50 (2%) | 1/49 (2%) | 2/49 (4.1%) | 2/48 (4.2%) | 1/49 (2%) | 1/49 (2%) | 1/50 (2%) | 1/49 (2%) | ||||||||
Sinusitis | 0/50 (0%) | 1/49 (2%) | 0/49 (0%) | 1/48 (2.1%) | 2/49 (4.1%) | 2/49 (4.1%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Skin infection | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Syphilis | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Tinea infection | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Tinea versicolour | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 1/48 (2.1%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Tonsillitis | 1/50 (2%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Tooth abscess | 0/50 (0%) | 1/49 (2%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Tooth infection | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Trichomoniasis | 2/50 (4%) | 0/49 (0%) | 1/49 (2%) | 1/48 (2.1%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Typhoid fever | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Upper respiratory tract infection | 5/50 (10%) | 6/49 (12.2%) | 2/49 (4.1%) | 6/48 (12.5%) | 5/49 (10.2%) | 7/49 (14.3%) | 6/50 (12%) | 9/49 (18.4%) | ||||||||
Urethritis | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Urethritis chlamydial | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Urinary tract infection | 2/50 (4%) | 2/49 (4.1%) | 5/49 (10.2%) | 5/48 (10.4%) | 3/49 (6.1%) | 3/49 (6.1%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Urogenital trichomoniasis | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Varicella | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Viral infection | 2/50 (4%) | 1/49 (2%) | 3/49 (6.1%) | 1/48 (2.1%) | 0/49 (0%) | 3/49 (6.1%) | 3/50 (6%) | 1/49 (2%) | ||||||||
Viral upper respiratory tract infection | 0/50 (0%) | 1/49 (2%) | 1/49 (2%) | 0/48 (0%) | 3/49 (6.1%) | 2/49 (4.1%) | 1/50 (2%) | 1/49 (2%) | ||||||||
Vulvovaginal candidiasis | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 1/48 (2.1%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Vulvovaginal mycotic infection | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Vulvovaginitis trichomonal | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Injury, poisoning and procedural complications | ||||||||||||||||
Arthropod bite | 0/50 (0%) | 1/49 (2%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Contusion | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 1/48 (2.1%) | 2/49 (4.1%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Gun shot wound | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Laceration | 0/50 (0%) | 2/49 (4.1%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Ligament sprain | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 1/48 (2.1%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Limb injury | 0/50 (0%) | 1/49 (2%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Muscle contusion | 1/50 (2%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Muscle strain | 0/50 (0%) | 1/49 (2%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Post procedural haematoma | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Post procedural haemorrhage | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 1/48 (2.1%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Procedural dizziness | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Procedural headache | 4/50 (8%) | 3/49 (6.1%) | 5/49 (10.2%) | 2/48 (4.2%) | 4/49 (8.2%) | 1/49 (2%) | 2/50 (4%) | 2/49 (4.1%) | ||||||||
Procedural pain | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Skin abrasion | 1/50 (2%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Soft tissue injury | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 1/48 (2.1%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Stress fracture | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Thermal burn | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 1/48 (2.1%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Wound | 0/50 (0%) | 1/49 (2%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Procedural nausea | 1/50 (2%) | 2/49 (4.1%) | 2/49 (4.1%) | 3/48 (6.3%) | 2/49 (4.1%) | 1/49 (2%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Procedural vomiting | 0/50 (0%) | 0/49 (0%) | 2/49 (4.1%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Investigations | ||||||||||||||||
Alanine aminotransferase increased | 6/50 (12%) | 3/49 (6.1%) | 2/49 (4.1%) | 2/48 (4.2%) | 4/49 (8.2%) | 3/49 (6.1%) | 3/50 (6%) | 1/49 (2%) | ||||||||
Aspartate aminotransferase increased | 4/50 (8%) | 1/49 (2%) | 4/49 (8.2%) | 1/48 (2.1%) | 2/49 (4.1%) | 3/49 (6.1%) | 3/50 (6%) | 2/49 (4.1%) | ||||||||
Blood creatine increased | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Blood creatinine decreased | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Blood creatinine increased | 3/50 (6%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 2/49 (4.1%) | 2/50 (4%) | 1/49 (2%) | ||||||||
Blood glucose increased | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Blood pressure diastolic increased | 0/50 (0%) | 1/49 (2%) | 0/49 (0%) | 2/48 (4.2%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Blood pressure increased | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 2/48 (4.2%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 2/49 (4.1%) | ||||||||
Blood pressure systolic | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Blood pressure systolic increased | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 2/48 (4.2%) | 1/49 (2%) | 0/49 (0%) | 1/50 (2%) | 2/49 (4.1%) | ||||||||
Blood urine present | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Electrocardiogram QT prolonged | 2/50 (4%) | 1/49 (2%) | 3/49 (6.1%) | 3/48 (6.3%) | 0/49 (0%) | 4/49 (8.2%) | 2/50 (4%) | 2/49 (4.1%) | ||||||||
Eosinophil percentage increased | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Haemoglobin decreased | 1/50 (2%) | 2/49 (4.1%) | 4/49 (8.2%) | 4/48 (8.3%) | 0/49 (0%) | 3/49 (6.1%) | 2/50 (4%) | 0/49 (0%) | ||||||||
Neutrophil count decreased | 1/50 (2%) | 1/49 (2%) | 2/49 (4.1%) | 0/48 (0%) | 1/49 (2%) | 3/49 (6.1%) | 1/50 (2%) | 1/49 (2%) | ||||||||
Platelet count decreased | 0/50 (0%) | 2/49 (4.1%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Protein urine | 2/50 (4%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 2/49 (4.1%) | 2/49 (4.1%) | 1/50 (2%) | 3/49 (6.1%) | ||||||||
Red blood cells urine | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
White blood cells urine | 0/50 (0%) | 1/49 (2%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Body temperature increased | 0/50 (0%) | 2/49 (4.1%) | 2/49 (4.1%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Metabolism and nutrition disorders | ||||||||||||||||
Abnormal loss of weight | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Decreased appetite | 1/50 (2%) | 1/49 (2%) | 1/49 (2%) | 0/48 (0%) | 2/49 (4.1%) | 1/49 (2%) | 3/50 (6%) | 0/49 (0%) | ||||||||
Musculoskeletal and connective tissue disorders | ||||||||||||||||
Arthralgia | 19/50 (38%) | 18/49 (36.7%) | 15/49 (30.6%) | 11/48 (22.9%) | 19/49 (38.8%) | 11/49 (22.4%) | 11/50 (22%) | 10/49 (20.4%) | ||||||||
Back pain | 2/50 (4%) | 3/49 (6.1%) | 3/49 (6.1%) | 4/48 (8.3%) | 1/49 (2%) | 2/49 (4.1%) | 2/50 (4%) | 1/49 (2%) | ||||||||
Bursitis | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Muscle spasms | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Muscular weakness | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Musculoskeletal chest pain | 1/50 (2%) | 1/49 (2%) | 1/49 (2%) | 1/48 (2.1%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Musculoskeletal pain | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 1/49 (2%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Myalgia | 24/50 (48%) | 20/49 (40.8%) | 20/49 (40.8%) | 17/48 (35.4%) | 20/49 (40.8%) | 24/49 (49%) | 16/50 (32%) | 16/49 (32.7%) | ||||||||
Neck pain | 1/50 (2%) | 0/49 (0%) | 1/49 (2%) | 1/48 (2.1%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Pain in extremity | 2/50 (4%) | 0/49 (0%) | 0/49 (0%) | 2/48 (4.2%) | 2/49 (4.1%) | 1/49 (2%) | 1/50 (2%) | 1/49 (2%) | ||||||||
Rhabdomyolysis | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Musculoskeletal stiffness | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 2/48 (4.2%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Nervous system disorders | ||||||||||||||||
Burning sensation | 0/50 (0%) | 1/49 (2%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Dizziness | 1/50 (2%) | 1/49 (2%) | 0/49 (0%) | 1/48 (2.1%) | 2/49 (4.1%) | 1/49 (2%) | 1/50 (2%) | 1/49 (2%) | ||||||||
Dizziness exertional | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Dizziness postural | 1/50 (2%) | 1/49 (2%) | 3/49 (6.1%) | 1/48 (2.1%) | 1/49 (2%) | 2/49 (4.1%) | 1/50 (2%) | 2/49 (4.1%) | ||||||||
Dysgeusia | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Headache | 29/50 (58%) | 32/49 (65.3%) | 27/49 (55.1%) | 26/48 (54.2%) | 28/49 (57.1%) | 26/49 (53.1%) | 23/50 (46%) | 20/49 (40.8%) | ||||||||
Hyperaesthesia | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Hypoaesthesia | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Paraesthesia | 0/50 (0%) | 1/49 (2%) | 1/49 (2%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 2/49 (4.1%) | ||||||||
Parosmia | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Presyncope | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 2/50 (4%) | 0/49 (0%) | ||||||||
Somnolence | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Syncope | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Migraine | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Psychiatric disorders | ||||||||||||||||
Affective disorder | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Anxiety | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 1/48 (2.1%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Confusional state | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 1/48 (2.1%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Depression | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 1/48 (2.1%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Insomnia | 0/50 (0%) | 1/49 (2%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Libido disorder | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Renal and urinary disorders | ||||||||||||||||
Chronic kidney disease | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Dysuria | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Haematuria | 1/50 (2%) | 1/49 (2%) | 2/49 (4.1%) | 3/48 (6.3%) | 0/49 (0%) | 2/49 (4.1%) | 1/50 (2%) | 2/49 (4.1%) | ||||||||
Ketonuria | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Nephrolithiasis | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Pollakiuria | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Proteinuria | 4/50 (8%) | 4/49 (8.2%) | 2/49 (4.1%) | 3/48 (6.3%) | 1/49 (2%) | 4/49 (8.2%) | 6/50 (12%) | 4/49 (8.2%) | ||||||||
Renal impairment | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Reproductive system and breast disorders | ||||||||||||||||
Balanoposthitis | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Breast tenderness | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Dysmenorrhoea | 0/50 (0%) | 0/49 (0%) | 2/49 (4.1%) | 2/48 (4.2%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Erectile dysfunction | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Genital discharge | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Genital rash | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Genital ulceration | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Menorrhagia | 0/50 (0%) | 0/49 (0%) | 2/49 (4.1%) | 1/48 (2.1%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Metrorrhagia | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Premenstrual syndrome | 0/50 (0%) | 1/49 (2%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Vaginal discharge | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Vaginal haemorrhage | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
Allergic sinusitis | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Cough | 2/50 (4%) | 1/49 (2%) | 0/49 (0%) | 4/48 (8.3%) | 2/49 (4.1%) | 2/49 (4.1%) | 4/50 (8%) | 1/49 (2%) | ||||||||
Dry throat | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Dyspnoea exertional | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 1/48 (2.1%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Nasal congestion | 2/50 (4%) | 1/49 (2%) | 0/49 (0%) | 2/48 (4.2%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 1/49 (2%) | ||||||||
Oropharyngeal pain | 2/50 (4%) | 1/49 (2%) | 0/49 (0%) | 0/48 (0%) | 3/49 (6.1%) | 2/49 (4.1%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Pleurisy | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Pleuritic pain | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Rhinalgia | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 1/48 (2.1%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Rhinitis allergic | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Rhinorrhoea | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 2/48 (4.2%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Sinus congestion | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Sneezing | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 2/49 (4.1%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Skin and subcutaneous tissue disorders | ||||||||||||||||
Acne | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Cold sweat | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Dermatitis allergic | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Dermatitis atopic | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Dermatitis contact | 1/50 (2%) | 1/49 (2%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Dermatosis | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Dry skin | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Eczema | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Hyperhidrosis | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 1/48 (2.1%) | 0/49 (0%) | 1/49 (2%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Night sweats | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 1/48 (2.1%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Pruritus | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 3/48 (6.3%) | 2/49 (4.1%) | 3/49 (6.1%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Rash | 1/50 (2%) | 3/49 (6.1%) | 1/49 (2%) | 1/48 (2.1%) | 1/49 (2%) | 1/49 (2%) | 1/50 (2%) | 2/49 (4.1%) | ||||||||
Rash generalised | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 1/49 (2%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Rash maculo-papular | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Rash papular | 1/50 (2%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Urticaria | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Erythema | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 2/49 (4.1%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Pruritus generalised | 4/50 (8%) | 2/49 (4.1%) | 2/49 (4.1%) | 2/48 (4.2%) | 3/49 (6.1%) | 2/49 (4.1%) | 4/50 (8%) | 7/49 (14.3%) | ||||||||
Rash macular | 0/50 (0%) | 1/49 (2%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Rash pruritic | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) | ||||||||
Social circumstances | ||||||||||||||||
Pregnancy of partner | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 1/49 (2%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Vascular disorders | ||||||||||||||||
Hypertension | 1/50 (2%) | 1/49 (2%) | 1/49 (2%) | 1/48 (2.1%) | 0/49 (0%) | 2/49 (4.1%) | 1/50 (2%) | 0/49 (0%) | ||||||||
Hypotension | 0/50 (0%) | 0/49 (0%) | 1/49 (2%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 0/49 (0%) | ||||||||
Systolic hypertension | 0/50 (0%) | 0/49 (0%) | 0/49 (0%) | 0/48 (0%) | 0/49 (0%) | 0/49 (0%) | 0/50 (0%) | 1/49 (2%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
Name/Title | Senior Director |
---|---|
Organization | Janssen Vaccines & Prevention B.V. |
Phone | 844-434-4210 |
ClinicalTrialDisclosure@its.jnj.com |
- CR106152
- HIV-V-A004
- IPCAVD009