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

Sponsor
Janssen Vaccines & Prevention B.V. (Industry)
Overall Status
Completed
CT.gov ID
NCT02315703
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) (NIH), US Military HIV Research Program (Other), Beth Israel Deaconess Medical Center (Other), International AIDS Vaccine Initiative (Other)
393
12
8
87
32.8
0.4

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
  • Biological: Ad26.Mos.HIV
  • Biological: MVA-Mosaic
  • Biological: gp140 DP Low-dose
  • Biological: gp140 DP High-dose
  • Drug: Placebo
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

Study Type:
Interventional
Actual Enrollment :
393 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
A Phase 1/2a Trial to Evaluate the Safety/Tolerability and Immunogenicity of Homologous Ad26 Mosaic Vector Regimens or Ad26 Mosaic and MVA Mosaic Heterologous Vector Regimens, With High-Dose, Low-Dose or no Clade C gp140 Protein Plus Adjuvant for HIV Prevention
Actual Study Start Date :
Dec 1, 2014
Actual Primary Completion Date :
Aug 1, 2017
Actual Study Completion Date :
Mar 1, 2022

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
Responsible Party:
Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier:
NCT02315703
Other Study ID Numbers:
  • CR106152
  • HIV-V-A004
  • IPCAVD009
First Posted:
Dec 12, 2014
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Janssen Vaccines & Prevention B.V.

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

1. Primary Outcome
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%
2. Primary Outcome
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%
3. Primary Outcome
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%
4. Primary Outcome
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%
5. Primary Outcome
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
6. Secondary Outcome
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
7. Secondary Outcome
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
8. Secondary Outcome
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
9. Secondary Outcome
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
10. Secondary Outcome
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
11. Secondary Outcome
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
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
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
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

[Not Specified]

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
Email ClinicalTrialDisclosure@its.jnj.com
Responsible Party:
Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier:
NCT02315703
Other Study ID Numbers:
  • CR106152
  • HIV-V-A004
  • IPCAVD009
First Posted:
Dec 12, 2014
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022