HIV Infections
Conditions
Keywords
HIV Seronegativity, HIV Preventive Vaccine, HIV Treatment Vaccine, Adenovirus
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.
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.
Interventions
BIOLOGICALDNA plasmid vaccine
4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid
BIOLOGICALRecombinant adenoviral serotype 5 (rAD5) vector vaccine
1 x 10\^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid
BIOLOGICALDNA vaccine placebo
1 mL IM via Biojector® in either deltoid
BIOLOGICALHIV-1 recombinant adenovirus vaccine placebo
1 mL administered IM by needle and syringe in either deltoid
Sponsors
HIV Vaccine Trials Network
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
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: 1. Unprotected anal intercourse with one or more male or MTF transgender partner(s) 2. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vaccine 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 | 1,253 |
| Placebo 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 | 1,251 |
| Total | 2,504 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 11 |
| Overall Study | HIV infection | 5 | 7 |
| Overall Study | Lost to Follow-up | 314 | 315 |
| Overall Study | Other; N=245 due to early study closure | 154 | 139 |
| Overall Study | Participant relocated | 78 | 107 |
| Overall Study | Participant unable to adhere | 27 | 42 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 45 | 65 |
Baseline characteristics
| Characteristic | Vaccine | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 29 years | 30 years | 29 years |
| Age, Customized 18-20 years | 105 Participants | 108 Participants | 213 Participants |
| Age, Customized 21-30 years | 585 Participants | 569 Participants | 1154 Participants |
| Age, Customized 31-40 years | 299 Participants | 299 Participants | 598 Participants |
| Age, Customized 41-50 years | 264 Participants | 275 Participants | 539 Participants |
| Any unprotected receptive anal sex with a partner within 3 months prior to screening assessment | 589 Participants | 573 Participants | 1162 Participants |
| Body Mass Index (BMI) 18.5-24.9 kg/m^2 | 550 Participants | 586 Participants | 1136 Participants |
| Body Mass Index (BMI) <18.5 kg/m^2 | 22 Participants | 16 Participants | 38 Participants |
| Body Mass Index (BMI) 25.0-29.9 kg/m^2 | 391 Participants | 381 Participants | 772 Participants |
| Body Mass Index (BMI) 30.0-34.9 kg/m^2 | 189 Participants | 167 Participants | 356 Participants |
| Body Mass Index (BMI) 35-39.9 kg/m^2 | 64 Participants | 59 Participants | 123 Participants |
| Body Mass Index (BMI) >=40 kg/m^2 | 36 Participants | 41 Participants | 77 Participants |
| Body Mass Index (BMI) Missing/Unknown | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 125 Participants | 94 Participants | 219 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1128 Participants | 1157 Participants | 2285 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Number of male sexual partners within 3 months prior to screening assessment 0 | 59 Participants | 64 Participants | 123 Participants |
| Number of male sexual partners within 3 months prior to screening assessment 1 | 256 Participants | 243 Participants | 499 Participants |
| Number of male sexual partners within 3 months prior to screening assessment 2 | 253 Participants | 242 Participants | 495 Participants |
| Number of male sexual partners within 3 months prior to screening assessment 3-4 | 349 Participants | 367 Participants | 716 Participants |
| Number of male sexual partners within 3 months prior to screening assessment 5 or more | 330 Participants | 327 Participants | 657 Participants |
| Number of male sexual partners within 3 months prior to screening assessment Unknown | 6 Participants | 8 Participants | 14 Participants |
| Number of male sexual partners within 3 months prior to screening assessment | 3 partners | 3 partners | 3 partners |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 10 Participants | 13 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 20 Participants | 33 Participants |
| Race (NIH/OMB) Black or African American | 222 Participants | 204 Participants | 426 Participants |
| Race (NIH/OMB) More than one race | 45 Participants | 46 Participants | 91 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 6 Participants | 10 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 27 Participants | 21 Participants | 48 Participants |
| Race (NIH/OMB) White | 939 Participants | 944 Participants | 1883 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1253 Participants | 1251 Participants | 2504 Participants |
| Sex/Gender, Customized Female | 4 Participants | 4 Participants | 8 Participants |
| Sex/Gender, Customized Male | 1231 Participants | 1229 Participants | 2460 Participants |
| Sex/Gender, Customized Other | 4 Participants | 2 Participants | 6 Participants |
| Sex/Gender, Customized Transgender Female | 13 Participants | 15 Participants | 28 Participants |
| Sex/Gender, Customized Transgender Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 1,253 | 11 / 1,251 |
| other Total, other adverse events | 833 / 1,253 | 828 / 1,251 |
| serious Total, serious adverse events | 77 / 1,253 | 95 / 1,251 |
Outcome results
Primary
HIV-1 Infections Diagnosed After Day 0 Including All Available Follow-up Through the Maximum 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.
Time frame: Enrollment through Month 48 visit
Population: Modified Intent-to-Treat Cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccine | HIV-1 Infections Diagnosed After Day 0 Including All Available Follow-up Through the Maximum Month 48 Visit | 75 participants |
| Placebo | HIV-1 Infections Diagnosed After Day 0 Including All Available Follow-up Through the Maximum Month 48 Visit | 68 participants |
p-value: 0.90395% CI: [0.73, 1.42]Regression, Cox
Primary
HIV-1 Infections Diagnosed After Day 0 Through the 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.
Time frame: Enrollment through Month 24 visit
Population: Modified Intent-to-Treat Cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccine | HIV-1 Infections Diagnosed After Day 0 Through the Month 24 Visit | 49 participants |
| Placebo | HIV-1 Infections Diagnosed After Day 0 Through the Month 24 Visit | 46 participants |
p-value: 0.78395% CI: [0.71, 1.58]Regression, Cox
Primary
Number of Participants Experiencing Local Reactogenicity: Erythema and/or Induration
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
Population: All enrolled participants
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine | Number of Participants Experiencing Local Reactogenicity: Erythema and/or Induration | >0 to 25 square cm | 498 Participants |
| Vaccine | Number of Participants Experiencing Local Reactogenicity: Erythema and/or Induration | >9 cm any diameter (grade 2) | 6 Participants |
| Vaccine | Number of Participants Experiencing Local Reactogenicity: Erythema and/or Induration | None | 717 Participants |
| Vaccine | Number of Participants Experiencing Local Reactogenicity: Erythema and/or Induration | >81 square cm (grade 2) | 17 Participants |
| Vaccine | Number of Participants Experiencing Local Reactogenicity: Erythema and/or Induration | >25 to 81 square cm (grade 1) | 15 Participants |
| Placebo | Number of Participants Experiencing Local Reactogenicity: Erythema and/or Induration | >81 square cm (grade 2) | 1 Participants |
| Placebo | Number of Participants Experiencing Local Reactogenicity: Erythema and/or Induration | >0 to 25 square cm | 268 Participants |
| Placebo | Number of Participants Experiencing Local Reactogenicity: Erythema and/or Induration | >25 to 81 square cm (grade 1) | 2 Participants |
| Placebo | Number of Participants Experiencing Local Reactogenicity: Erythema and/or Induration | >9 cm any diameter (grade 2) | 0 Participants |
| Placebo | Number of Participants Experiencing Local Reactogenicity: Erythema and/or Induration | None | 980 Participants |
Primary
Number of Participants Experiencing Local Reactogenicity: Pain and/or Tenderness
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
Population: All Enrolled Participants
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine | Number of Participants Experiencing Local Reactogenicity: Pain and/or Tenderness | Moderate | 370 Participants |
| Vaccine | Number of Participants Experiencing Local Reactogenicity: Pain and/or Tenderness | Severe | 22 Participants |
| Vaccine | Number of Participants Experiencing Local Reactogenicity: Pain and/or Tenderness | None | 138 Participants |
| Vaccine | Number of Participants Experiencing Local Reactogenicity: Pain and/or Tenderness | Mild | 723 Participants |
| Vaccine | Number of Participants Experiencing Local Reactogenicity: Pain and/or Tenderness | Potentially life-threatening | 0 Participants |
| Placebo | Number of Participants Experiencing Local Reactogenicity: Pain and/or Tenderness | Potentially life-threatening | 0 Participants |
| Placebo | Number of Participants Experiencing Local Reactogenicity: Pain and/or Tenderness | Moderate | 90 Participants |
| Placebo | Number of Participants Experiencing Local Reactogenicity: Pain and/or Tenderness | Mild | 744 Participants |
| Placebo | Number of Participants Experiencing Local Reactogenicity: Pain and/or Tenderness | Severe | 2 Participants |
| Placebo | Number of Participants Experiencing Local Reactogenicity: Pain and/or Tenderness | None | 415 Participants |
Primary
Number of Participants Experiencing Systemic Reactogenicity
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
Population: All enrolled participants
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine | Number of Participants Experiencing Systemic Reactogenicity | Mild | 408 Participants |
| Vaccine | Number of Participants Experiencing Systemic Reactogenicity | Severe | 42 Participants |
| Vaccine | Number of Participants Experiencing Systemic Reactogenicity | Moderate | 240 Participants |
| Vaccine | Number of Participants Experiencing Systemic Reactogenicity | Potentially life-threatening | 0 Participants |
| Vaccine | Number of Participants Experiencing Systemic Reactogenicity | None | 563 Participants |
| Placebo | Number of Participants Experiencing Systemic Reactogenicity | Potentially life-threatening | 0 Participants |
| Placebo | Number of Participants Experiencing Systemic Reactogenicity | None | 667 Participants |
| Placebo | Number of Participants Experiencing Systemic Reactogenicity | Mild | 406 Participants |
| Placebo | Number of Participants Experiencing Systemic Reactogenicity | Moderate | 169 Participants |
| Placebo | Number of Participants Experiencing Systemic Reactogenicity | Severe | 9 Participants |
Primary
Participant Dropout After Unblinding
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)
Population: MITT population participants who were HIV-uninfected and on-study as of April 23, 2013
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vaccine | Participant Dropout After Unblinding | 241 Participants |
| Placebo | Participant Dropout After Unblinding | 309 Participants |
Comparison: Assess the association between treatment assignment and dropoutp-value: <0.00195% CI: [0.6, 0.84]Regression, Cox
Primary
Participant Dropout Prior to Unblinding
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)
Population: MITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vaccine | Participant Dropout Prior to Unblinding | 99 Participants |
| Placebo | Participant Dropout Prior to Unblinding | 127 Participants |
Comparison: Cox PH model to assess the association between treatment assignment and dropoutp-value: 0.0595% CI: [0.59, 1]Regression, Cox
Primary
Participant Dropout Through Month 48
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
Population: MITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vaccine | Participant Dropout Through Month 48 | 340 Participants |
| Placebo | Participant Dropout Through Month 48 | 436 Participants |
Comparison: Cox proportional hazards model to assess the association between treatment assignment and dropoutp-value: <0.00195% CI: [0.63, 0.84]Regression, Cox