Safety and Effectiveness of HIV-1 DNA Plasmid Vaccine and HIV-1 Recombinant Adenoviral Vector Vaccine in HIV-Uninfected, Circumcised Men and Male-to-Female (MTF) Transgender Persons Who Have Sex With Men
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Terminated
CT.gov ID
NCT00865566
Collaborator
HIV Vaccine Trials Network (Other)
2,504
22
2
101.2
113.8
1.1
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the safety and efficacy of a VRC DNA/rAd5 vaccine regimen in healthy, circumcised men and male-to-female (MTF) transgender persons who have sex with men.
NOTES:
As of April 2013, all vaccinations in this study have been stopped.
As of June 2017, this study has been closed.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
In 2007, the Joint United Nations Programme on HIV/AIDS estimated that 33.2 million people were living with HIV/AIDS globally. The U.S. HIV prevalence data reported in October 2008 by the Centers for Disease Control and Prevention estimate that 1.1 million adults and adolescents were living with diagnosed or undiagnosed HIV infection in the United States at the end of 2006. Nearly half of all U.S. HIV infections (48.1%) were found in men who have sex with men (MSM). Given the difficulty of maintaining behaviors that prevent HIV transmission over a lifetime and the occurrence of nonconsensual sex, the need for a safe and effective vaccine is clear. The primary purpose of this study is to determine the safety and efficacy of a VRC DNA/rAd5 vaccine regimen in healthy, at-risk, circumcised men and MTF transgender persons who have sex with men.
Participants will be randomly assigned to one of two arms. Participants in Arm 1 will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. Participants in Arm 2 will receive placebo injections at study entry and on Days 28, 56, and 168.
Participants who do not become HIV infected will be actively followed for a minimum of 24 months and will continue to be followed by the study for long-term safety surveillance for a total of 5 years following enrollment. Participants will be contacted annually during the period of long-term safety surveillance.
Participants who are found to be HIV infected prior to receiving their first injection or who receive their first injection but were HIV infected prior to study start will be followed on a modified schedule.
Participants who become HIV infected will be followed for 6 months post-diagnosis.
At most study visits, participants will undergo a physical exam and blood draw.
NOTES:
As of April 2013, all vaccinations in this study have been stopped. Participants have been notified of whether they received the study vaccines or placebo. Participants diagnosed with HIV infection will attend study visits for 6 months for health monitoring. Participants who are not diagnosed with HIV infection will attend planned study visits for 24 months and will be followed by the study clinic at least annually for a total of 5 years following study enrollment.
As of June 2017, this study has been closed. Therefore, to avoid further burden on study participants, further participant follow-up for the study is suspended.
Study Design
Study Type:
Interventional
Actual Enrollment
:
2504 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Prevention
Official Title:
Phase 2b, Randomized, Placebo-Controlled Test-of-Concept Trial to Evaluate the Safety and Efficacy of a Multiclade HIV-1 DNA Plasmid Vaccine Followed by a Multiclade HIV-1 Recombinant Adenoviral Vector Vaccine in HIV-Uninfected, Adenovirus Type 5 Neutralizing Antibody Negative, Circumcised Men and Male-to-Female (MTF) Transgender Persons, Who Have Sex With Men
Study Start Date
:
May 1, 2009
Actual Primary Completion Date
:
Oct 6, 2017
Actual Study Completion Date
:
Oct 6, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. |
Biological: DNA plasmid vaccine
4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid
Other Names:
Biological: Recombinant adenoviral serotype 5 (rAD5) vector vaccine
1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid
Other Names:
|
| Placebo Comparator: 2 Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. |
Biological: DNA vaccine placebo
1 mL IM via Biojector® in either deltoid
Other Names:
Biological: HIV-1 recombinant adenovirus vaccine placebo
1 mL administered IM by needle and syringe in either deltoid
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Participant Dropout Through Month 48 [Enrollment through Month 48 visit]
For participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match.
- Participant Dropout Prior to Unblinding [Enrollment until the date of dropout, through April 22, 2013 (up to Month 24 visit)]
The trial was unblinded on April 23, 2013, and the protocol was in version 4 at the time. For participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match.
- Participant Dropout After Unblinding [April 23, 2013 through trial closure (up to Month 48 visit)]
The trial was unblinded on April 23, 2013, and the protocol was in version 4 at the time. For participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match.
- HIV-1 Infections Diagnosed After Day 0 Including All Available Follow-up Through the Maximum Month 48 Visit [Enrollment through Month 48 visit]
For time-to-event analysis, an event is defined as HIV-1 infection and participants are censored if they dropped out early or completed the trial. HIV-1 diagnosis date is defined as the date of the earliest specimen collection yielding a positive HIV test. Participants remaining uninfected were censored at the latest specimen collection with a negative HIV-1 test.
- HIV-1 Infections Diagnosed After Day 0 Through the Month 24 Visit [Enrollment through Month 24 visit]
For time-to-event analysis, an event is defined as HIV-1 infection and participants remaining uninfected through the month 24 visit were censored. HIV-1 diagnosis date is defined as the date of the earliest specimen collection at or prior to month 24 which yielded a positive HIV test. Participants remaining uninfected through the month 24 visit were censored at the latest specimen collection with a negative HIV-1 test at or prior to the month 24 visit.
- Number of Participants Experiencing Local Reactogenicity: Pain and/or Tenderness [Through 3 days post each study vaccination, and to resolution for events present at the third day post vaccination]
For each sign or symptom, we define the maximum observed grade for each participant over all vaccinations and post-vaccination assessments. Local and systemic signs and symptoms are assessed and graded based on The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December, 2004 (Clarification dated August 2009). Local reactogenicity parameters are pain, tenderness, erythema, and induration. We present the maximum grade for pain and/or tenderness, and erythema and/or induration.
- Number of Participants Experiencing Local Reactogenicity: Erythema and/or Induration [Through 3 days post each study vaccination, and to resolution for events present at the third day post vaccination]
For each sign or symptom, we define the maximum observed grade for each participant over all vaccinations and post-vaccination assessments. Local and systemic signs and symptoms are assessed and graded based on The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December, 2004 (Clarification dated August 2009). Local reactogenicity parameters are pain, tenderness, erythema, and induration. We present the maximum grade for pain and/or tenderness, and erythema and/or induration.
- Number of Participants Experiencing Systemic Reactogenicity [Through 3 days post each study vaccination, and to resolution for events present at the third day post vaccination]
For each sign or symptom, we define the maximum observed grade for each participant over all vaccinations and post-vaccination assessments. Local and systemic signs and symptoms are assessed and graded based on The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December, 2004 (Clarification dated August 2009). Systemic reactogenicity parameters are malaise/fatigue, myalgia, headache, nausea, vomiting, chills, and arthralgia. We present the maximum grade calculated over these parameters.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 50 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
HIV-1 and -2 negative
-
Good general health
-
Fully circumcised
-
Experienced one or both of the following HIV risk criteria in the 6 months before study entry:
-
Unprotected anal intercourse with one or more male or MTF transgender partner(s)
-
Anal intercourse with two or more male or MTF transgender partners
-
Alanine aminotransferase (ALT) 2.5 or less times the upper limit of normal (ULN)
-
Ad5 neutralizing antibody (nAb) titer less than 1:18
-
Have access to a participating study site and are willing to be followed during the study
-
Demonstrate understanding of the study
-
Willing to receive HIV test results
-
Willing to discuss HIV infection risks and amenable to risk-reduction counseling
-
Agrees not to enroll in another study of an investigational research agent before unblinding of this study
-
NOTE: MTF transgender volunteers who have undergone gender reassignment surgery (GRS) are eligible to participate if they provide documentation from a health care provider confirming that they were fully circumcised prior to GRS. MTF transgender volunteers who have not undergone GRS are eligible to participate if they meet all enrollment criteria. Receipt of hormonal therapy does not make a transgender volunteer ineligible.
Exclusion Criteria:
-
HIV vaccines in prior HIV vaccine trial. Participants who can provide documentation that they received a placebo in a prior HIV trial may be eligible.
-
Used antiretroviral (ARV) drugs for the purpose of HIV-1 prophylaxis for greater than or equal to 50% of days during the 3 months prior to first vaccination or for 30 consecutive days within the 60 days prior to first vaccination
-
Circumcised within 90 days prior to first vaccination or displays evidence that surgical site is not fully healed
-
Immunosuppressive medications within 168 days prior to first study vaccination. Participants who have used corticosteroid nasal sprays for allergic rhinitis; topical corticosteroids for mild, uncomplicated dermatitis; or oral/parenteral corticosteroids for nonchronic conditions are not excluded.
-
Blood products within 90 days prior to first study vaccination
-
Immunoglobulin within 90 days prior to first study vaccination
-
Live attenuated vaccines other than influenza vaccine within 30 days prior to first study vaccination
-
Investigational research agents within 90 days prior to first study vaccination
-
Influenza vaccine or any vaccines that are not live attenuated within 14 days prior to first study vaccination
-
Allergy treatment with antigen injections within 30 days prior to first study vaccination or that are scheduled within 14 days after first vaccination
-
Clinically significant medical condition, physical examination findings, abnormal laboratory results, or past medical history that, in the judgment of the investigator, has significant implications for current health
-
Any medical, psychiatric, or job-related responsibility that would interfere with the study. More information about this criterion can be found in the protocol.
-
Any concern that, in the opinion of the investigator, may interfere with a participant's completion of the post-vaccination symptom log
-
History of serious adverse reactions to vaccinations, including anaphylaxis or allergy to any of the vaccine's components
-
Current anti-tuberculosis prophylaxis or therapy
-
Autoimmune disease. People with mild, stable, and uncomplicated autoimmune disease that does not require immunosuppressive medication and that, in the judgment of the site investigator, is likely not subject to exacerbation and likely not to complicate reactogenicity and adverse event assessments are not excluded.
-
Immunodeficiency
-
Bleeding disorder
-
History of malignancy
-
Seizure disorder. People with a history of seizures who have had no seizures within the 3 years prior to study entry are not excluded.
-
Asthma other than mild, well-controlled asthma
-
Hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic angioedema
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alabama CRS | Birmingham | Alabama | United States | 35294 |
| 2 | The AIDS Research Alliance of America CRS | Los Angeles | California | United States | 90015 |
| 3 | UCLA CARE Center CRS | Los Angeles | California | United States | 90035 |
| 4 | Bridge HIV CRS | San Francisco | California | United States | 94143 |
| 5 | University of Colorado Hospital CRS | Aurora | Colorado | United States | 80045 |
| 6 | Orlando Immunology Center CRS | Orlando | Florida | United States | 32803 |
| 7 | The Hope Clinic of the Emory Vaccine Center CRS | Decatur | Georgia | United States | 30030 |
| 8 | UIC Project WISH CRS | Chicago | Illinois | United States | 60612 |
| 9 | VRC Clinical Trials Core CRS | Bethesda | Maryland | United States | 20816 |
| 10 | Brigham and Women's Hospital Vaccine CRS (BWH VCRS) | Boston | Massachusetts | United States | 02115-6110 |
| 11 | Fenway Health (FH) CRS | Boston | Massachusetts | United States | 02215-4302 |
| 12 | NY Univ. HIV/AIDS CRS | New York | New York | United States | 10016 |
| 13 | Columbia P&S CRS | New York | New York | United States | 10032-3732 |
| 14 | New York Blood Center CRS | New York | New York | United States | 10065 |
| 15 | University of Rochester Vaccines to Prevent HIV Infection CRS | Rochester | New York | United States | 14642 |
| 16 | Case Clinical Research Site | Cleveland | Ohio | United States | 44106 |
| 17 | Penn Prevention CRS | Philadelphia | Pennsylvania | United States | 19104 |
| 18 | Vanderbilt Vaccine (VV) CRS | Nashville | Tennessee | United States | 37232-2582 |
| 19 | University of Texas Southwestern CRS | Dallas | Texas | United States | 75235 |
| 20 | Baylor Vaccine Research Center CRS | Houston | Texas | United States | 77030 |
| 21 | Care-Id Crs | Annandale | Virginia | United States | 22003 |
| 22 | Seattle Vaccine and Prevention CRS | Seattle | Washington | United States | 98109-1024 |
Sponsors and Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- HIV Vaccine Trials Network
Investigators
- Study Chair: Scott Hammer, Columbia University
- Study Chair: Magdalena Sobieszczyk, Columbia University
- Study Chair: Michael Yin, Columbia University
Study Documents (Full-Text)
More Information
Publications
- Lu S. Immunogenicity of DNA vaccines in humans: it takes two to tango. Hum Vaccin. 2008 Nov-Dec;4(6):449-52. Epub 2008 Nov 28. Review.
- Patterson S, Papagatsias T, Benlahrech A. Use of adenovirus in vaccines for HIV. Handb Exp Pharmacol. 2009;(188):275-93. doi: 10.1007/978-3-540-71029-5_13. Review.
Responsible Party:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00865566
Other Study ID Numbers:
- HVTN 505
- 10753
- NCT00919789
First Posted:
Mar 19, 2009
Last Update Posted:
Oct 15, 2021
Last Verified:
Oct 1, 2021
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Vaccine | Placebo |
|---|---|---|
| Arm/Group Description | Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid | Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid |
| Period Title: Overall Study | ||
| STARTED | 1253 | 1251 |
| Modified Intent-to-Treat Population | 1251 | 1245 |
| COMPLETED | 629 | 564 |
| NOT COMPLETED | 624 | 687 |
Baseline Characteristics
| Arm/Group Title | Vaccine | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid | Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid | Total of all reporting groups |
| Overall Participants | 1253 | 1251 | 2504 |
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
29
|
30
|
29
|
| Age, Customized (Count of Participants) | |||
| 18-20 years |
105
8.4%
|
108
8.6%
|
213
8.5%
|
| 21-30 years |
585
46.7%
|
569
45.5%
|
1154
46.1%
|
| 31-40 years |
299
23.9%
|
299
23.9%
|
598
23.9%
|
| 41-50 years |
264
21.1%
|
275
22%
|
539
21.5%
|
| Sex/Gender, Customized (Count of Participants) | |||
| Male |
1231
98.2%
|
1229
98.2%
|
2460
98.2%
|
| Female |
4
0.3%
|
4
0.3%
|
8
0.3%
|
| Transgender Male |
1
0.1%
|
1
0.1%
|
2
0.1%
|
| Transgender Female |
13
1%
|
15
1.2%
|
28
1.1%
|
| Other |
4
0.3%
|
2
0.2%
|
6
0.2%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
0
0%
|
0
0%
|
0
0%
|
| Male |
1253
100%
|
1251
100%
|
2504
100%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
125
10%
|
94
7.5%
|
219
8.7%
|
| Not Hispanic or Latino |
1128
90%
|
1157
92.5%
|
2285
91.3%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
3
0.2%
|
10
0.8%
|
13
0.5%
|
| Asian |
13
1%
|
20
1.6%
|
33
1.3%
|
| Native Hawaiian or Other Pacific Islander |
4
0.3%
|
6
0.5%
|
10
0.4%
|
| Black or African American |
222
17.7%
|
204
16.3%
|
426
17%
|
| White |
939
74.9%
|
944
75.5%
|
1883
75.2%
|
| More than one race |
45
3.6%
|
46
3.7%
|
91
3.6%
|
| Unknown or Not Reported |
27
2.2%
|
21
1.7%
|
48
1.9%
|
| Body Mass Index (BMI) (Count of Participants) | |||
| <18.5 kg/m^2 |
22
1.8%
|
16
1.3%
|
38
1.5%
|
| 18.5-24.9 kg/m^2 |
550
43.9%
|
586
46.8%
|
1136
45.4%
|
| 25.0-29.9 kg/m^2 |
391
31.2%
|
381
30.5%
|
772
30.8%
|
| 30.0-34.9 kg/m^2 |
189
15.1%
|
167
13.3%
|
356
14.2%
|
| 35-39.9 kg/m^2 |
64
5.1%
|
59
4.7%
|
123
4.9%
|
| >=40 kg/m^2 |
36
2.9%
|
41
3.3%
|
77
3.1%
|
| Missing/Unknown |
1
0.1%
|
1
0.1%
|
2
0.1%
|
| Number of male sexual partners within 3 months prior to screening assessment (Count of Participants) | |||
| 0 |
59
4.7%
|
64
5.1%
|
123
4.9%
|
| 1 |
256
20.4%
|
243
19.4%
|
499
19.9%
|
| 2 |
253
20.2%
|
242
19.3%
|
495
19.8%
|
| 3-4 |
349
27.9%
|
367
29.3%
|
716
28.6%
|
| 5 or more |
330
26.3%
|
327
26.1%
|
657
26.2%
|
| Unknown |
6
0.5%
|
8
0.6%
|
14
0.6%
|
| Number of male sexual partners within 3 months prior to screening assessment (partners) [Median (Full Range) ] | |||
| Median (Full Range) [partners] |
3
|
3
|
3
|
| Any unprotected receptive anal sex with a partner within 3 months prior to screening assessment (Count of Participants) | |||
| Count of Participants [Participants] |
589
47%
|
573
45.8%
|
1162
46.4%
|
Outcome Measures
| Title | Participant Dropout Through Month 48 |
|---|---|
| Description | For participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match. |
| Time Frame | Enrollment through Month 48 visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population |
| Arm/Group Title | Vaccine | Placebo |
|---|---|---|
| Arm/Group Description | Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid | Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid |
| Measure Participants | 1251 | 1245 |
| Count of Participants [Participants] |
340
27.1%
|
436
34.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Vaccine, Placebo |
|---|---|---|
| Comments | Cox proportional hazards model to assess the association between treatment assignment and dropout | |
| Type of Statistical Test | Other | |
| Comments | Score test | |
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.73 | |
| Confidence Interval |
(2-Sided) 95% 0.63 to 0.84 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | HR is vaccine / placebo | |
| Title | Participant Dropout Prior to Unblinding |
|---|---|
| Description | The trial was unblinded on April 23, 2013, and the protocol was in version 4 at the time. For participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match. |
| Time Frame | Enrollment until the date of dropout, through April 22, 2013 (up to Month 24 visit) |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population |
| Arm/Group Title | Vaccine | Placebo |
|---|---|---|
| Arm/Group Description | Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid | Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid |
| Measure Participants | 1251 | 1245 |
| Count of Participants [Participants] |
99
7.9%
|
127
10.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Vaccine, Placebo |
|---|---|---|
| Comments | Cox PH model to assess the association between treatment assignment and dropout | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.05 |
| Comments | Score test | |
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.77 | |
| Confidence Interval |
(2-Sided) 95% 0.59 to 1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | HR is vaccine / placebo | |
| Title | Participant Dropout After Unblinding |
|---|---|
| Description | The trial was unblinded on April 23, 2013, and the protocol was in version 4 at the time. For participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match. |
| Time Frame | April 23, 2013 through trial closure (up to Month 48 visit) |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT population participants who were HIV-uninfected and on-study as of April 23, 2013 |
| Arm/Group Title | Vaccine | Placebo |
|---|---|---|
| Arm/Group Description | Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid | Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid |
| Measure Participants | 1036 | 999 |
| Count of Participants [Participants] |
241
19.2%
|
309
24.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Vaccine, Placebo |
|---|---|---|
| Comments | Assess the association between treatment assignment and dropout | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Score test | |
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 0.71 | |
| Confidence Interval |
(2-Sided) 95% 0.60 to 0.84 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | HR is vaccine / placebo | |
| Title | HIV-1 Infections Diagnosed After Day 0 Including All Available Follow-up Through the Maximum Month 48 Visit |
|---|---|
| Description | For time-to-event analysis, an event is defined as HIV-1 infection and participants are censored if they dropped out early or completed the trial. HIV-1 diagnosis date is defined as the date of the earliest specimen collection yielding a positive HIV test. Participants remaining uninfected were censored at the latest specimen collection with a negative HIV-1 test. |
| Time Frame | Enrollment through Month 48 visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified Intent-to-Treat Cohort |
| Arm/Group Title | Vaccine | Placebo |
|---|---|---|
| Arm/Group Description | Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid | Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid |
| Measure Participants | 1251 | 1245 |
| Number [participants] |
75
6%
|
68
5.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Vaccine, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.903 |
| Comments | Score test | |
| Method | Regression, Cox | |
| Comments | Adjusted for age, behavioral risk score, square of behavioral risk score, race, and BMI | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.02 | |
| Confidence Interval |
(2-Sided) 95% 0.73 to 1.42 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | HR is vaccine / placebo | |
| Title | HIV-1 Infections Diagnosed After Day 0 Through the Month 24 Visit |
|---|---|
| Description | For time-to-event analysis, an event is defined as HIV-1 infection and participants remaining uninfected through the month 24 visit were censored. HIV-1 diagnosis date is defined as the date of the earliest specimen collection at or prior to month 24 which yielded a positive HIV test. Participants remaining uninfected through the month 24 visit were censored at the latest specimen collection with a negative HIV-1 test at or prior to the month 24 visit. |
| Time Frame | Enrollment through Month 24 visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified Intent-to-Treat Cohort |
| Arm/Group Title | Vaccine | Placebo |
|---|---|---|
| Arm/Group Description | Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid | Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid |
| Measure Participants | 1251 | 1245 |
| Number [participants] |
49
3.9%
|
46
3.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Vaccine, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.783 |
| Comments | Adjusted for ave, behavioral risk score, square of behavioral risk score, and BMI | |
| Method | Regression, Cox | |
| Comments | Score test | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.06 | |
| Confidence Interval |
(2-Sided) 95% 0.71 to 1.58 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | HR is vaccine / placebo | |
| Title | Number of Participants Experiencing Local Reactogenicity: Pain and/or Tenderness |
|---|---|
| Description | For each sign or symptom, we define the maximum observed grade for each participant over all vaccinations and post-vaccination assessments. Local and systemic signs and symptoms are assessed and graded based on The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December, 2004 (Clarification dated August 2009). Local reactogenicity parameters are pain, tenderness, erythema, and induration. We present the maximum grade for pain and/or tenderness, and erythema and/or induration. |
| Time Frame | Through 3 days post each study vaccination, and to resolution for events present at the third day post vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| All Enrolled Participants |
| Arm/Group Title | Vaccine | Placebo |
|---|---|---|
| Arm/Group Description | Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid | Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid |
| Measure Participants | 1253 | 1251 |
| None |
138
11%
|
415
33.2%
|
| Mild |
723
57.7%
|
744
59.5%
|
| Moderate |
370
29.5%
|
90
7.2%
|
| Severe |
22
1.8%
|
2
0.2%
|
| Potentially life-threatening |
0
0%
|
0
0%
|
| Title | Number of Participants Experiencing Local Reactogenicity: Erythema and/or Induration |
|---|---|
| Description | For each sign or symptom, we define the maximum observed grade for each participant over all vaccinations and post-vaccination assessments. Local and systemic signs and symptoms are assessed and graded based on The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December, 2004 (Clarification dated August 2009). Local reactogenicity parameters are pain, tenderness, erythema, and induration. We present the maximum grade for pain and/or tenderness, and erythema and/or induration. |
| Time Frame | Through 3 days post each study vaccination, and to resolution for events present at the third day post vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants |
| Arm/Group Title | Vaccine | Placebo |
|---|---|---|
| Arm/Group Description | Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid | Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid |
| Measure Participants | 1253 | 1251 |
| None |
717
57.2%
|
980
78.3%
|
| >0 to 25 square cm |
498
39.7%
|
268
21.4%
|
| >25 to 81 square cm (grade 1) |
15
1.2%
|
2
0.2%
|
| >9 cm any diameter (grade 2) |
6
0.5%
|
0
0%
|
| >81 square cm (grade 2) |
17
1.4%
|
1
0.1%
|
| Title | Number of Participants Experiencing Systemic Reactogenicity |
|---|---|
| Description | For each sign or symptom, we define the maximum observed grade for each participant over all vaccinations and post-vaccination assessments. Local and systemic signs and symptoms are assessed and graded based on The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December, 2004 (Clarification dated August 2009). Systemic reactogenicity parameters are malaise/fatigue, myalgia, headache, nausea, vomiting, chills, and arthralgia. We present the maximum grade calculated over these parameters. |
| Time Frame | Through 3 days post each study vaccination, and to resolution for events present at the third day post vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants |
| Arm/Group Title | Vaccine | Placebo |
|---|---|---|
| Arm/Group Description | Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid | Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid |
| Measure Participants | 1253 | 1251 |
| None |
563
44.9%
|
667
53.3%
|
| Mild |
408
32.6%
|
406
32.5%
|
| Moderate |
240
19.2%
|
169
13.5%
|
| Severe |
42
3.4%
|
9
0.7%
|
| Potentially life-threatening |
0
0%
|
0
0%
|
Adverse Events
| Time Frame | Reporting of all AEs occurred during 2 periods for each participant: 1) from enrollment through 28 days after the third vaccination, and 2) from the fourth vaccination through 28 days after the fourth vaccination. Between and after these time periods, only SAEs, new chronic conditions requiring medical intervention of more than 30 days, and newly diagnosed/treated STIs were reported. Events requiring expedited reporting (protocol section 12.3) were reported through the study, up to 60 months. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Vaccine | Placebo | ||
| Arm/Group Description | Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid | Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid | ||
All Cause Mortality |
||||
| Vaccine | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/1253 (0.1%) | 11/1251 (0.9%) | ||
Serious Adverse Events |
||||
| Vaccine | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 77/1253 (6.1%) | 95/1251 (7.6%) | ||
| Blood and lymphatic system disorders | ||||
| Any event in SOC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Anaemias NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Cardiac disorders | ||||
| Any event in SOC | 1/1253 (0.1%) | 6/1251 (0.5%) | ||
| Ischaemic coronary artery disorders | 1/1253 (0.1%) | 2/1251 (0.2%) | ||
| Coronary artery disorders NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Heart failures NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Supraventricular arrhythmias | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Ventricular arrhythmias and cardiac arrest | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Congenital, familial and genetic disorders | ||||
| Any event in SOC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Haemoglobinopathies congenital | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Gastrointestinal disorders | ||||
| Any event in SOC | 2/1253 (0.2%) | 15/1251 (1.2%) | ||
| Colitis (excl infective) | 1/1253 (0.1%) | 3/1251 (0.2%) | ||
| Acute and chronic pancreatitis | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Duodenal ulcers and perforation | 0/1253 (0%) | 2/1251 (0.2%) | ||
| Intestinal ulcers and perforation NEC | 0/1253 (0%) | 2/1251 (0.2%) | ||
| Abdominal hernias NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Gastric ulcers and perforation | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Gastrointestinal atonic and hypomotility disorders NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Gastrointestinal disorders NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Gastrointestinal stenosis and obstruction NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Non-site specific gastrointestinal haemorrhages | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Oesophageal ulcers and perforation | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Rectal inflammations NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| General disorders | ||||
| Any event in SOC | 2/1253 (0.2%) | 5/1251 (0.4%) | ||
| Pain and discomfort NEC | 1/1253 (0.1%) | 3/1251 (0.2%) | ||
| Death and sudden death | 0/1253 (0%) | 2/1251 (0.2%) | ||
| Withdrawal and rebound effects | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Immune system disorders | ||||
| Any event in SOC | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Acute and chronic sarcoidosis | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Allergies to foods, food additives, drugs and other chemicals | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Infections and infestations | ||||
| Any event in SOC | 25/1253 (2%) | 26/1251 (2.1%) | ||
| Abdominal and gastrointestinal infections | 8/1253 (0.6%) | 11/1251 (0.9%) | ||
| Bacterial infections NEC | 5/1253 (0.4%) | 4/1251 (0.3%) | ||
| Infections NEC | 2/1253 (0.2%) | 3/1251 (0.2%) | ||
| Lower respiratory tract and lung infections | 3/1253 (0.2%) | 1/1251 (0.1%) | ||
| Upper respiratory tract infections | 1/1253 (0.1%) | 2/1251 (0.2%) | ||
| Clostridia infections | 2/1253 (0.2%) | 0/1251 (0%) | ||
| Sepsis, bacteraemia, viraemia and fungaemia NEC | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Skin structures and soft tissue infections | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Staphylococcal infections | 2/1253 (0.2%) | 0/1251 (0%) | ||
| Streptococcal infections | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Bone and joint infections | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Borrelial infections | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Breast infections | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Herpes viral infections | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Infectious disorders carrier | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Urinary tract infections | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Viral infections NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Injury, poisoning and procedural complications | ||||
| Any event in SOC | 15/1253 (1.2%) | 15/1251 (1.2%) | ||
| Limb fractures and dislocations | 4/1253 (0.3%) | 2/1251 (0.2%) | ||
| Skull fractures, facial bone fractures and dislocations | 2/1253 (0.2%) | 3/1251 (0.2%) | ||
| Non-site specific injuries NEC | 2/1253 (0.2%) | 2/1251 (0.2%) | ||
| Overdoses NEC | 1/1253 (0.1%) | 2/1251 (0.2%) | ||
| Poisoning and toxicity | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Site specific injuries NEC | 2/1253 (0.2%) | 0/1251 (0%) | ||
| Skin injuries NEC | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Spinal fractures and dislocations | 0/1253 (0%) | 2/1251 (0.2%) | ||
| Abdominal injuries NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Cardiac and vascular procedural complications | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Cardiovascular injuries | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Cerebral injuries NEC | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Muscle, tendon and ligament injuries | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Pathways and sources of exposure | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Thermal burns | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Investigations | ||||
| Any event in SOC | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Liver function analyses | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Metabolism tests NEC | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Any event in SOC | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Potassium imbalance | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Any event in SOC | 1/1253 (0.1%) | 3/1251 (0.2%) | ||
| Bursal disorders | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Intervertebral disc disorders NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Muscle weakness conditions | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Myopathies | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Any event in SOC | 4/1253 (0.3%) | 3/1251 (0.2%) | ||
| Prostatic neoplasms malignant | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Colorectal neoplasms malignant | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Gastric neoplasms malignant | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Leukaemias acute lymphocytic | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Testicular neoplasms malignant | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Thyroid neoplasms malignant | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Nervous system disorders | ||||
| Any event in SOC | 7/1253 (0.6%) | 2/1251 (0.2%) | ||
| Seizures and seizure disorders NEC | 3/1253 (0.2%) | 0/1251 (0%) | ||
| Central nervous system haemorrhages and cerebrovascular accidents | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Encephalopathies NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Mononeuropathies | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Neurological signs and symptoms NEC | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Optic nerve disorders NEC | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Transient cerebrovascular events | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Product Issues | ||||
| Any event in SOC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Device malfunction events NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Psychiatric disorders | ||||
| Any event in SOC | 23/1253 (1.8%) | 22/1251 (1.8%) | ||
| Suicidal and self-injurious behaviour | 13/1253 (1%) | 11/1251 (0.9%) | ||
| Depressive disorders | 4/1253 (0.3%) | 3/1251 (0.2%) | ||
| Substance related and addictive disorders | 5/1253 (0.4%) | 2/1251 (0.2%) | ||
| Bipolar disorders | 0/1253 (0%) | 3/1251 (0.2%) | ||
| Anxiety symptoms | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Psychotic disorder NEC | 0/1253 (0%) | 2/1251 (0.2%) | ||
| Confusion and disorientation | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Mental disorders NEC | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Schizoaffective and schizophreniform disorders | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Schizophrenia NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Somatic symptom disorders | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Renal and urinary disorders | ||||
| Any event in SOC | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Renal failure and impairment | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Renal lithiasis | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Reproductive system and breast disorders | ||||
| Any event in SOC | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Testicular and epididymal disorders NEC | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Any event in SOC | 3/1253 (0.2%) | 2/1251 (0.2%) | ||
| Pulmonary thrombotic and embolic conditions | 2/1253 (0.2%) | 1/1251 (0.1%) | ||
| Pneumothorax and pleural effusions NEC | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Any event in SOC | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Skin and subcutaneous tissue ulcerations | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Vascular disorders | ||||
| Any event in SOC | 4/1253 (0.3%) | 1/1251 (0.1%) | ||
| Peripheral embolism and thrombosis | 2/1253 (0.2%) | 0/1251 (0%) | ||
| Non-site specific necrosis and vascular insufficiency NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Vascular hypertensive disorders NEC | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Vascular hypotensive disorders | 1/1253 (0.1%) | 0/1251 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Vaccine | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 833/1253 (66.5%) | 828/1251 (66.2%) | ||
| Blood and lymphatic system disorders | ||||
| Any event in SOC | 22/1253 (1.8%) | 17/1251 (1.4%) | ||
| Lymphatic system disorders NEC | 20/1253 (1.6%) | 15/1251 (1.2%) | ||
| Anaemias NEC | 2/1253 (0.2%) | 0/1251 (0%) | ||
| Leukocytoses NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Red blood cell abnormal findings NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Spleen disorders | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Cardiac disorders | ||||
| Any event in SOC | 2/1253 (0.2%) | 5/1251 (0.4%) | ||
| Supraventricular arrhythmias | 1/1253 (0.1%) | 2/1251 (0.2%) | ||
| Cardiac signs and symptoms NEC | 0/1253 (0%) | 2/1251 (0.2%) | ||
| Rate and rhythm disorders NEC | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Congenital, familial and genetic disorders | ||||
| Any event in SOC | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Male reproductive tract disorders congenital | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Ear and labyrinth disorders | ||||
| Any event in SOC | 10/1253 (0.8%) | 7/1251 (0.6%) | ||
| Ear disorders NEC | 3/1253 (0.2%) | 5/1251 (0.4%) | ||
| Inner ear signs and symptoms | 3/1253 (0.2%) | 1/1251 (0.1%) | ||
| External ear disorders NEC | 1/1253 (0.1%) | 2/1251 (0.2%) | ||
| Middle ear disorders NEC | 2/1253 (0.2%) | 0/1251 (0%) | ||
| Eustachian tube disorders | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Hearing losses | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Tympanic membrane disorders (excl infections) | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Endocrine disorders | ||||
| Any event in SOC | 8/1253 (0.6%) | 2/1251 (0.2%) | ||
| Thyroid hypofunction disorders | 4/1253 (0.3%) | 2/1251 (0.2%) | ||
| Endocrine abnormalities of gonadal function NEC | 2/1253 (0.2%) | 0/1251 (0%) | ||
| Male gonadal function disorders | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Thyroid hyperfunction disorders | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Eye disorders | ||||
| Any event in SOC | 17/1253 (1.4%) | 11/1251 (0.9%) | ||
| Lid, lash and lacrimal infections, irritations and inflammations | 4/1253 (0.3%) | 1/1251 (0.1%) | ||
| Ocular disorders NEC | 2/1253 (0.2%) | 2/1251 (0.2%) | ||
| Conjunctival and corneal bleeding and vascular disorders | 2/1253 (0.2%) | 1/1251 (0.1%) | ||
| Ocular sensation disorders | 0/1253 (0%) | 3/1251 (0.2%) | ||
| Visual disorders NEC | 3/1253 (0.2%) | 0/1251 (0%) | ||
| Conjunctival infections, irritations and inflammations | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Eyelid movement disorders | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Lacrimation disorders | 2/1253 (0.2%) | 0/1251 (0%) | ||
| Ocular infections, inflammations and associated manifestations | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Blindness (excl colour blindness) | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Glaucomas (excl congenital) | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Refractive and accommodative disorders | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Retinal, choroid and vitreous infections and inflammations | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Gastrointestinal disorders | ||||
| Any event in SOC | 149/1253 (11.9%) | 146/1251 (11.7%) | ||
| Diarrhoea (excl infective) | 53/1253 (4.2%) | 53/1251 (4.2%) | ||
| Nausea and vomiting symptoms | 28/1253 (2.2%) | 21/1251 (1.7%) | ||
| Gastrointestinal and abdominal pains (excl oral and throat) | 22/1253 (1.8%) | 13/1251 (1%) | ||
| Stomatitis and ulceration | 11/1253 (0.9%) | 6/1251 (0.5%) | ||
| Gastrointestinal atonic and hypomotility disorders NEC | 6/1253 (0.5%) | 9/1251 (0.7%) | ||
| Haemorrhoids and gastrointestinal varices (excl oesophageal) | 5/1253 (0.4%) | 9/1251 (0.7%) | ||
| Anal and rectal disorders NEC | 5/1253 (0.4%) | 8/1251 (0.6%) | ||
| Gastrointestinal signs and symptoms NEC | 7/1253 (0.6%) | 6/1251 (0.5%) | ||
| Gastrointestinal disorders NEC | 7/1253 (0.6%) | 4/1251 (0.3%) | ||
| Dental pain and sensation disorders | 6/1253 (0.5%) | 4/1251 (0.3%) | ||
| Dyspeptic signs and symptoms | 1/1253 (0.1%) | 6/1251 (0.5%) | ||
| Intestinal haemorrhages | 2/1253 (0.2%) | 5/1251 (0.4%) | ||
| Gastritis (excl infective) | 3/1253 (0.2%) | 3/1251 (0.2%) | ||
| Colitis (excl infective) | 0/1253 (0%) | 4/1251 (0.3%) | ||
| Non-site specific gastrointestinal haemorrhages | 2/1253 (0.2%) | 2/1251 (0.2%) | ||
| Abdominal hernias NEC | 2/1253 (0.2%) | 1/1251 (0.1%) | ||
| Anal and rectal signs and symptoms | 2/1253 (0.2%) | 1/1251 (0.1%) | ||
| Dental and periodontal infections and inflammations | 2/1253 (0.2%) | 1/1251 (0.1%) | ||
| Diaphragmatic hernias | 2/1253 (0.2%) | 1/1251 (0.1%) | ||
| Flatulence, bloating and distension | 1/1253 (0.1%) | 2/1251 (0.2%) | ||
| Gingival disorders NEC | 2/1253 (0.2%) | 1/1251 (0.1%) | ||
| Gingival haemorrhages | 2/1253 (0.2%) | 1/1251 (0.1%) | ||
| Oesophageal ulcers and perforation | 2/1253 (0.2%) | 1/1251 (0.1%) | ||
| Tongue disorders | 3/1253 (0.2%) | 0/1251 (0%) | ||
| Tongue signs and symptoms | 1/1253 (0.1%) | 2/1251 (0.2%) | ||
| Benign neoplasms gastrointestinal (excl oral cavity) | 0/1253 (0%) | 2/1251 (0.2%) | ||
| Gastrointestinal inflammatory disorders NEC | 2/1253 (0.2%) | 0/1251 (0%) | ||
| Oral dryness and saliva altered | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Abdominal findings abnormal | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Anal and rectal pains | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Dental disorders NEC | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Faecal abnormalities NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Gastrointestinal dyskinetic disorders | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Gastrointestinal fistulae | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Inguinal hernias | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Oral soft tissue pain and paraesthesia | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Peptic ulcers and perforation | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Rectal inflammations NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| General disorders | ||||
| Any event in SOC | 138/1253 (11%) | 104/1251 (8.3%) | ||
| Injection site reactions | 65/1253 (5.2%) | 33/1251 (2.6%) | ||
| Asthenic conditions | 41/1253 (3.3%) | 27/1251 (2.2%) | ||
| Febrile disorders | 17/1253 (1.4%) | 15/1251 (1.2%) | ||
| Feelings and sensations NEC | 10/1253 (0.8%) | 9/1251 (0.7%) | ||
| General signs and symptoms NEC | 6/1253 (0.5%) | 10/1251 (0.8%) | ||
| Pain and discomfort NEC | 6/1253 (0.5%) | 5/1251 (0.4%) | ||
| Administration site reactions NEC | 3/1253 (0.2%) | 6/1251 (0.5%) | ||
| Oedema NEC | 2/1253 (0.2%) | 5/1251 (0.4%) | ||
| Therapeutic and nontherapeutic responses | 2/1253 (0.2%) | 4/1251 (0.3%) | ||
| Vaccination site reactions | 5/1253 (0.4%) | 1/1251 (0.1%) | ||
| Mass conditions NEC | 0/1253 (0%) | 3/1251 (0.2%) | ||
| Withdrawal and rebound effects | 2/1253 (0.2%) | 1/1251 (0.1%) | ||
| Inflammations | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Hepatobiliary disorders | ||||
| Any event in SOC | 3/1253 (0.2%) | 3/1251 (0.2%) | ||
| Hepatocellular damage and hepatitis NEC | 2/1253 (0.2%) | 1/1251 (0.1%) | ||
| Cholecystitis and cholelithiasis | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Cholestasis and jaundice | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Hepatobiliary signs and symptoms | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Immune system disorders | ||||
| Any event in SOC | 25/1253 (2%) | 14/1251 (1.1%) | ||
| Atopic disorders | 10/1253 (0.8%) | 7/1251 (0.6%) | ||
| Allergies to foods, food additives, drugs and other chemicals | 9/1253 (0.7%) | 5/1251 (0.4%) | ||
| Allergic conditions NEC | 6/1253 (0.5%) | 1/1251 (0.1%) | ||
| Anaphylactic and anaphylactoid responses | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Infections and infestations | ||||
| Any event in SOC | 531/1253 (42.4%) | 549/1251 (43.9%) | ||
| Upper respiratory tract infections | 275/1253 (21.9%) | 254/1251 (20.3%) | ||
| Neisseria infections | 79/1253 (6.3%) | 83/1251 (6.6%) | ||
| Viral infections NEC | 75/1253 (6%) | 72/1251 (5.8%) | ||
| Chlamydial infections | 72/1253 (5.7%) | 72/1251 (5.8%) | ||
| Treponema infections | 32/1253 (2.6%) | 41/1251 (3.3%) | ||
| Abdominal and gastrointestinal infections | 37/1253 (3%) | 29/1251 (2.3%) | ||
| Herpes viral infections | 31/1253 (2.5%) | 30/1251 (2.4%) | ||
| Streptococcal infections | 22/1253 (1.8%) | 31/1251 (2.5%) | ||
| Urinary tract infections | 20/1253 (1.6%) | 24/1251 (1.9%) | ||
| Lower respiratory tract and lung infections | 16/1253 (1.3%) | 14/1251 (1.1%) | ||
| Papilloma viral infections | 12/1253 (1%) | 17/1251 (1.4%) | ||
| Bacterial infections NEC | 15/1253 (1.2%) | 11/1251 (0.9%) | ||
| Eye and eyelid infections | 9/1253 (0.7%) | 17/1251 (1.4%) | ||
| Skin structures and soft tissue infections | 11/1253 (0.9%) | 14/1251 (1.1%) | ||
| Dental and oral soft tissue infections | 9/1253 (0.7%) | 14/1251 (1.1%) | ||
| Ectoparasitic infestations | 8/1253 (0.6%) | 15/1251 (1.2%) | ||
| Ear infections | 8/1253 (0.6%) | 10/1251 (0.8%) | ||
| Staphylococcal infections | 10/1253 (0.8%) | 5/1251 (0.4%) | ||
| Tinea infections | 6/1253 (0.5%) | 8/1251 (0.6%) | ||
| Influenza viral infections | 5/1253 (0.4%) | 5/1251 (0.4%) | ||
| Infections NEC | 5/1253 (0.4%) | 4/1251 (0.3%) | ||
| Male reproductive tract infections | 3/1253 (0.2%) | 5/1251 (0.4%) | ||
| Fungal infections NEC | 5/1253 (0.4%) | 1/1251 (0.1%) | ||
| Hepatitis viral infections | 1/1253 (0.1%) | 4/1251 (0.3%) | ||
| Candida infections | 1/1253 (0.1%) | 2/1251 (0.2%) | ||
| Molluscum contagiosum viral infections | 1/1253 (0.1%) | 2/1251 (0.2%) | ||
| Epstein-Barr viral infections | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Giardia infections | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Tuberculous infections | 0/1253 (0%) | 2/1251 (0.2%) | ||
| Amoebic infections | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Bone and joint infections | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Caliciviral infections | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Clostridia infections | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Coxsackie viral infections | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Cytomegaloviral infections | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Escherichia infections | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Haemophilus infections | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Helicobacter infections | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Nematode infections | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Injury, poisoning and procedural complications | ||||
| Any event in SOC | 108/1253 (8.6%) | 101/1251 (8.1%) | ||
| Skin injuries NEC | 28/1253 (2.2%) | 20/1251 (1.6%) | ||
| Muscle, tendon and ligament injuries | 24/1253 (1.9%) | 23/1251 (1.8%) | ||
| Non-site specific injuries NEC | 13/1253 (1%) | 9/1251 (0.7%) | ||
| Non-site specific procedural complications | 12/1253 (1%) | 8/1251 (0.6%) | ||
| Limb fractures and dislocations | 9/1253 (0.7%) | 10/1251 (0.8%) | ||
| Site specific injuries NEC | 8/1253 (0.6%) | 8/1251 (0.6%) | ||
| Neurological and psychiatric procedural complications | 10/1253 (0.8%) | 3/1251 (0.2%) | ||
| Bone and joint injuries NEC | 4/1253 (0.3%) | 5/1251 (0.4%) | ||
| Thermal burns | 2/1253 (0.2%) | 7/1251 (0.6%) | ||
| Exposures to agents or circumstances NEC | 4/1253 (0.3%) | 2/1251 (0.2%) | ||
| Radiation injuries | 3/1253 (0.2%) | 3/1251 (0.2%) | ||
| Cerebral injuries NEC | 3/1253 (0.2%) | 2/1251 (0.2%) | ||
| Fractures and dislocations NEC | 1/1253 (0.1%) | 4/1251 (0.3%) | ||
| Eye injuries NEC | 2/1253 (0.2%) | 1/1251 (0.1%) | ||
| Skull fractures, facial bone fractures and dislocations | 0/1253 (0%) | 3/1251 (0.2%) | ||
| Thoracic cage fractures and dislocations | 1/1253 (0.1%) | 2/1251 (0.2%) | ||
| Chest and lung injuries NEC | 2/1253 (0.2%) | 0/1251 (0%) | ||
| Gastrointestinal and hepatobiliary procedural complications | 0/1253 (0%) | 2/1251 (0.2%) | ||
| Ear injuries NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Overdoses NEC | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Poisoning and toxicity | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Reproductive system and breast injuries | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Spinal fractures and dislocations | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Vaccination related complications | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Investigations | ||||
| Any event in SOC | 39/1253 (3.1%) | 63/1251 (5%) | ||
| Vascular tests NEC (incl blood pressure) | 28/1253 (2.2%) | 47/1251 (3.8%) | ||
| Reproductive hormone analyses | 3/1253 (0.2%) | 7/1251 (0.6%) | ||
| Liver function analyses | 3/1253 (0.2%) | 3/1251 (0.2%) | ||
| Red blood cell analyses | 2/1253 (0.2%) | 2/1251 (0.2%) | ||
| Carbohydrate tolerance analyses (incl diabetes) | 2/1253 (0.2%) | 1/1251 (0.1%) | ||
| Digestive enzymes | 2/1253 (0.2%) | 0/1251 (0%) | ||
| Mineral and electrolyte analyses | 2/1253 (0.2%) | 0/1251 (0%) | ||
| Platelet analyses | 0/1253 (0%) | 2/1251 (0.2%) | ||
| Bacteria identification and serology (excl mycobacteria) | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Cardiac auscultatory investigations | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Coagulation and bleeding analyses | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Heart rate and pulse investigations | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Investigations NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Musculoskeletal and soft tissue tests NEC | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Mycobacteria identification and serology | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Tissue enzyme analyses NEC | 1/1253 (0.1%) | 0/1251 (0%) | ||
| White blood cell analyses | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Metabolism and nutrition disorders | ||||
| Any event in SOC | 27/1253 (2.2%) | 20/1251 (1.6%) | ||
| Diabetes mellitus (incl subtypes) | 7/1253 (0.6%) | 3/1251 (0.2%) | ||
| Fat soluble vitamin deficiencies and disorders | 3/1253 (0.2%) | 5/1251 (0.4%) | ||
| Appetite disorders | 5/1253 (0.4%) | 1/1251 (0.1%) | ||
| Elevated cholesterol | 2/1253 (0.2%) | 3/1251 (0.2%) | ||
| Disorders of purine metabolism | 3/1253 (0.2%) | 0/1251 (0%) | ||
| General nutritional disorders NEC | 2/1253 (0.2%) | 1/1251 (0.1%) | ||
| Potassium imbalance | 2/1253 (0.2%) | 1/1251 (0.1%) | ||
| Fluid intake increased | 2/1253 (0.2%) | 0/1251 (0%) | ||
| Food malabsorption and intolerance syndromes (excl sugar intolerance) | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Lipid metabolism and deposit disorders NEC | 2/1253 (0.2%) | 0/1251 (0%) | ||
| Water soluble vitamin deficiencies | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Elevated triglycerides | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Hyperlipidaemias NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Hypoglycaemic conditions NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Magnesium metabolism disorders | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Protein metabolism disorders NEC | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Sugar intolerance (excl glucose intolerance) | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Any event in SOC | 97/1253 (7.7%) | 107/1251 (8.6%) | ||
| Musculoskeletal and connective tissue pain and discomfort | 47/1253 (3.8%) | 49/1251 (3.9%) | ||
| Muscle pains | 25/1253 (2%) | 24/1251 (1.9%) | ||
| Joint related signs and symptoms | 17/1253 (1.4%) | 19/1251 (1.5%) | ||
| Muscle related signs and symptoms NEC | 7/1253 (0.6%) | 2/1251 (0.2%) | ||
| Tendon disorders | 3/1253 (0.2%) | 3/1251 (0.2%) | ||
| Bone related signs and symptoms | 2/1253 (0.2%) | 3/1251 (0.2%) | ||
| Arthropathies NEC | 1/1253 (0.1%) | 2/1251 (0.2%) | ||
| Bone disorders NEC | 1/1253 (0.1%) | 2/1251 (0.2%) | ||
| Bursal disorders | 1/1253 (0.1%) | 2/1251 (0.2%) | ||
| Intervertebral disc disorders NEC | 1/1253 (0.1%) | 2/1251 (0.2%) | ||
| Muscle weakness conditions | 0/1253 (0%) | 3/1251 (0.2%) | ||
| Muscle tone abnormalities | 0/1253 (0%) | 2/1251 (0.2%) | ||
| Cartilage disorders | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Extremity deformities | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Joint related disorders NEC | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Musculoskeletal and connective tissue infections and inflammations NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Osteoarthropathies | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Rheumatoid arthropathies | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Soft tissue disorders NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Synovial disorders | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Any event in SOC | 18/1253 (1.4%) | 17/1251 (1.4%) | ||
| Skin neoplasms benign | 13/1253 (1%) | 14/1251 (1.1%) | ||
| Lip and oral cavity neoplasms benign | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Skin neoplasms malignant and unspecified (excl melanoma) | 2/1253 (0.2%) | 0/1251 (0%) | ||
| Soft tissue neoplasms benign NEC | 2/1253 (0.2%) | 0/1251 (0%) | ||
| Nervous system neoplasms benign NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Reproductive neoplasms male benign NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Nervous system disorders | ||||
| Any event in SOC | 103/1253 (8.2%) | 88/1251 (7%) | ||
| Headaches NEC | 39/1253 (3.1%) | 41/1251 (3.3%) | ||
| Neurological signs and symptoms NEC | 30/1253 (2.4%) | 22/1251 (1.8%) | ||
| Paraesthesias and dysaesthesias | 10/1253 (0.8%) | 11/1251 (0.9%) | ||
| Migraine headaches | 8/1253 (0.6%) | 2/1251 (0.2%) | ||
| Sensory abnormalities NEC | 8/1253 (0.6%) | 1/1251 (0.1%) | ||
| Disturbances in consciousness NEC | 7/1253 (0.6%) | 1/1251 (0.1%) | ||
| Mononeuropathies | 2/1253 (0.2%) | 3/1251 (0.2%) | ||
| Peripheral neuropathies NEC | 4/1253 (0.3%) | 1/1251 (0.1%) | ||
| Lumbar spinal cord and nerve root disorders | 2/1253 (0.2%) | 1/1251 (0.1%) | ||
| Narcolepsy and hypersomnia | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Seizures and seizure disorders NEC | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Cervical spinal cord and nerve root disorders | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Coordination and balance disturbances | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Disturbances in sleep phase rhythm | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Facial cranial nerve disorders | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Memory loss (excl dementia) | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Mental impairment (excl dementia and memory loss) | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Neurologic visual problems NEC | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Sleep disturbances NEC | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Psychiatric disorders | ||||
| Any event in SOC | 72/1253 (5.7%) | 65/1251 (5.2%) | ||
| Depressive disorders | 25/1253 (2%) | 22/1251 (1.8%) | ||
| Anxiety symptoms | 20/1253 (1.6%) | 17/1251 (1.4%) | ||
| Disturbances in initiating and maintaining sleep | 8/1253 (0.6%) | 12/1251 (1%) | ||
| Substance related and addictive disorders | 9/1253 (0.7%) | 4/1251 (0.3%) | ||
| Attention deficit and disruptive behaviour disorders | 3/1253 (0.2%) | 4/1251 (0.3%) | ||
| Anxiety disorders NEC | 5/1253 (0.4%) | 1/1251 (0.1%) | ||
| Bipolar disorders | 2/1253 (0.2%) | 3/1251 (0.2%) | ||
| Panic attacks and disorders | 3/1253 (0.2%) | 2/1251 (0.2%) | ||
| Sexual desire disorders | 3/1253 (0.2%) | 2/1251 (0.2%) | ||
| Stress disorders | 2/1253 (0.2%) | 1/1251 (0.1%) | ||
| Emotional and mood disturbances NEC | 0/1253 (0%) | 2/1251 (0.2%) | ||
| Schizophrenia NEC | 2/1253 (0.2%) | 0/1251 (0%) | ||
| Behaviour and socialisation disturbances | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Fear symptoms and phobic disorders (incl social phobia) | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Fluctuating mood symptoms | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Mental disorders NEC | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Mood alterations with depressive symptoms | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Mood disorders NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Schizoaffective and schizophreniform disorders | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Sleep disorders NEC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Somatic symptom disorders | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Suicidal and self-injurious behaviour | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Renal and urinary disorders | ||||
| Any event in SOC | 19/1253 (1.5%) | 23/1251 (1.8%) | ||
| Bladder and urethral symptoms | 11/1253 (0.9%) | 12/1251 (1%) | ||
| Renal lithiasis | 4/1253 (0.3%) | 6/1251 (0.5%) | ||
| Urethral disorders NEC | 1/1253 (0.1%) | 4/1251 (0.3%) | ||
| Urinary abnormalities | 1/1253 (0.1%) | 2/1251 (0.2%) | ||
| Urinary tract signs and symptoms NEC | 2/1253 (0.2%) | 1/1251 (0.1%) | ||
| Bladder neoplasms | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Reproductive system and breast disorders | ||||
| Any event in SOC | 27/1253 (2.2%) | 26/1251 (2.1%) | ||
| Penile disorders NEC (excl erection and ejaculation) | 12/1253 (1%) | 7/1251 (0.6%) | ||
| Reproductive tract signs and symptoms NEC | 5/1253 (0.4%) | 4/1251 (0.3%) | ||
| Erection and ejaculation conditions and disorders | 1/1253 (0.1%) | 5/1251 (0.4%) | ||
| Prostate and seminal vesicles infections and inflammations | 2/1253 (0.2%) | 4/1251 (0.3%) | ||
| Reproductive tract disorders NEC (excl neoplasms) | 3/1253 (0.2%) | 1/1251 (0.1%) | ||
| Testicular and epididymal disorders NEC | 3/1253 (0.2%) | 1/1251 (0.1%) | ||
| Breast signs and symptoms | 0/1253 (0%) | 2/1251 (0.2%) | ||
| Scrotal disorders NEC | 0/1253 (0%) | 2/1251 (0.2%) | ||
| Breast disorders NEC | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Pelvic prolapse conditions | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Sexual function and fertility disorders NEC | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Spermatogenesis and semen disorders | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Testicular and epididymal neoplasms | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Any event in SOC | 123/1253 (9.8%) | 95/1251 (7.6%) | ||
| Upper respiratory tract signs and symptoms | 49/1253 (3.9%) | 44/1251 (3.5%) | ||
| Coughing and associated symptoms | 34/1253 (2.7%) | 24/1251 (1.9%) | ||
| Nasal congestion and inflammations | 22/1253 (1.8%) | 17/1251 (1.4%) | ||
| Paranasal sinus disorders (excl infections and neoplasms) | 15/1253 (1.2%) | 10/1251 (0.8%) | ||
| Bronchospasm and obstruction | 7/1253 (0.6%) | 6/1251 (0.5%) | ||
| Pharyngeal disorders (excl infections and neoplasms) | 5/1253 (0.4%) | 4/1251 (0.3%) | ||
| Breathing abnormalities | 5/1253 (0.4%) | 3/1251 (0.2%) | ||
| Nasal disorders NEC | 2/1253 (0.2%) | 4/1251 (0.3%) | ||
| Respiratory tract disorders NEC | 3/1253 (0.2%) | 1/1251 (0.1%) | ||
| Laryngeal and adjacent sites disorders NEC (excl infections and neoplasms) | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Pulmonary oedemas | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Respiratory failures (excl neonatal) | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Any event in SOC | 112/1253 (8.9%) | 86/1251 (6.9%) | ||
| Dermatitis and eczema | 29/1253 (2.3%) | 17/1251 (1.4%) | ||
| Rashes, eruptions and exanthems NEC | 21/1253 (1.7%) | 25/1251 (2%) | ||
| Apocrine and eccrine gland disorders | 17/1253 (1.4%) | 11/1251 (0.9%) | ||
| Dermal and epidermal conditions NEC | 11/1253 (0.9%) | 11/1251 (0.9%) | ||
| Pruritus NEC | 14/1253 (1.1%) | 8/1251 (0.6%) | ||
| Erythemas | 7/1253 (0.6%) | 2/1251 (0.2%) | ||
| Psoriatic conditions | 6/1253 (0.5%) | 3/1251 (0.2%) | ||
| Acnes | 3/1253 (0.2%) | 3/1251 (0.2%) | ||
| Angioedemas | 2/1253 (0.2%) | 1/1251 (0.1%) | ||
| Bullous conditions | 2/1253 (0.2%) | 1/1251 (0.1%) | ||
| Papulosquamous conditions | 1/1253 (0.1%) | 2/1251 (0.2%) | ||
| Pilar disorders NEC | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Purpura and related conditions | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Skin and subcutaneous tissue ulcerations | 2/1253 (0.2%) | 0/1251 (0%) | ||
| Skin cysts and polyps | 1/1253 (0.1%) | 1/1251 (0.1%) | ||
| Skin preneoplastic conditions NEC | 2/1253 (0.2%) | 0/1251 (0%) | ||
| Alopecias | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Dermatitis ascribed to specific agent | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Hyperkeratoses | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Hyperpigmentation disorders | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Photosensitivity and photodermatosis conditions | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Rosaceas | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Social circumstances | ||||
| Any event in SOC | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Crime victims | 0/1253 (0%) | 1/1251 (0.1%) | ||
| Vascular disorders | ||||
| Any event in SOC | 33/1253 (2.6%) | 49/1251 (3.9%) | ||
| Vascular hypertensive disorders NEC | 25/1253 (2%) | 42/1251 (3.4%) | ||
| Peripheral vascular disorders NEC | 5/1253 (0.4%) | 4/1251 (0.3%) | ||
| Haemorrhages NEC | 2/1253 (0.2%) | 2/1251 (0.2%) | ||
| Lymphoedemas | 1/1253 (0.1%) | 0/1251 (0%) | ||
| Peripheral embolism and thrombosis | 0/1253 (0%) | 1/1251 (0.1%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations |
|---|---|
| Organization | Fred Hutchinson Cancer Research Center |
| Phone | 206-667-5812 |
| jandries@fredhutch.org |
Responsible Party:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00865566
Other Study ID Numbers:
- HVTN 505
- 10753
- NCT00919789
First Posted:
Mar 19, 2009
Last Update Posted:
Oct 15, 2021
Last Verified:
Oct 1, 2021