Trial · NCT00865566
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
NCT00865566, Phase 2, Terminated, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2019-02-27
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ConductScience Library. 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. Trials, record NCT00865566. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00865566
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT00865566
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 2,504 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- HIV Infections
- Interventions
- DNA plasmid vaccine, Recombinant adenoviral serotype 5 (rAD5) vector vaccine, DNA vaccine placebo, HIV-1 recombinant adenovirus vaccine placebo
- First posted
- 2009-03-19
- Last updated
- 2021-10-15
- Results first posted
- 2019-02-27
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participant Dropout Through Month 48 | Enrollment through Month 48 visit | MITT population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Participant Dropout Prior to Unblinding | Enrollment until the date of dropout, through April 22, 2013 (up to Month 24 visit) | MITT population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Participant Dropout After Unblinding | April 23, 2013 through trial closure (up to Month 48 visit) | MITT population participants who were HIV-uninfected and on-study as of April 23, 2013 | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | HIV-1 Infections Diagnosed After Day 0 Including All Available Follow-up Through the Maximum Month 48 Visit | Enrollment through Month 48 visit | Modified Intent-to-Treat Cohort | participants | NUMBER |
| PRIMARY | HIV-1 Infections Diagnosed After Day 0 Through the Month 24 Visit | Enrollment through Month 24 visit | Modified Intent-to-Treat Cohort | participants | NUMBER |
| PRIMARY | 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 | All Enrolled Participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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 | All enrolled participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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 | All enrolled participants | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participant Dropout Through Month 48 | Vaccine | 340 | Participants | ||
| Participant Dropout Through Month 48 | Placebo | 436 | Participants | ||
| Participant Dropout Prior to Unblinding | Vaccine | 99 | Participants | ||
| Participant Dropout Prior to Unblinding | Placebo | 127 | Participants | ||
| Participant Dropout After Unblinding | Vaccine | 241 | Participants | ||
| Participant Dropout After Unblinding | Placebo | 309 | Participants | ||
| HIV-1 Infections Diagnosed After Day 0 Including All Available Follow-up Through the Maximum Month 48 Visit | Vaccine | 75 | participants | ||
| HIV-1 Infections Diagnosed After Day 0 Including All Available Follow-up Through the Maximum Month 48 Visit | Placebo | 68 | participants | ||
| HIV-1 Infections Diagnosed After Day 0 Through the Month 24 Visit | Vaccine | 49 | participants | ||
| HIV-1 Infections Diagnosed After Day 0 Through the Month 24 Visit | Placebo | 46 | participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vaccine | 1,253 | |
| Overall Study | STARTED | Placebo | 1,251 | |
| Overall Study | Modified Intent-to-Treat Population | Vaccine | 1,251 | |
| Overall Study | Modified Intent-to-Treat Population | Placebo | 1,245 | |
| Overall Study | COMPLETED | Vaccine | 629 | |
| Overall Study | COMPLETED | Placebo | 564 | |
| Overall Study | NOT COMPLETED | Vaccine | 624 | |
| Overall Study | NOT COMPLETED | Placebo | 687 |
Source ClinicalTrials.gov
Adverse events916
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Any event in SOC | Blood and lymphatic system disorders | Vaccine | 22 | 1,253 | |
| other | Any event in SOC | Blood and lymphatic system disorders | Placebo | 17 | 1,251 | |
| other | Lymphatic system disorders NEC | Blood and lymphatic system disorders | Vaccine | 20 | 1,253 | |
| other | Lymphatic system disorders NEC | Blood and lymphatic system disorders | Placebo | 15 | 1,251 | |
| other | Anaemias NEC | Blood and lymphatic system disorders | Vaccine | 2 | 1,253 | |
| other | Anaemias NEC | Blood and lymphatic system disorders | Placebo | 0 | 1,251 | |
| other | Leukocytoses NEC | Blood and lymphatic system disorders | Vaccine | 0 | 1,253 | |
| other | Leukocytoses NEC | Blood and lymphatic system disorders | Placebo | 1 | 1,251 | |
| other | Red blood cell abnormal findings NEC | Blood and lymphatic system disorders | Vaccine | 0 | 1,253 | |
| other | Red blood cell abnormal findings NEC | Blood and lymphatic system disorders | Placebo | 1 | 1,251 |
1 to 10 of 916Source ClinicalTrials.gov
See all 916 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vaccine | 1 | 1,253 |
| Total, all-cause mortality | Placebo | 11 | 1,251 |
| Total, other adverse events | Vaccine | 833 | 1,253 |
| Total, other adverse events | Placebo | 828 | 1,251 |
| Total, serious adverse events | Vaccine | 77 | 1,253 |
| Total, serious adverse events | Placebo | 95 | 1,251 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vaccine vs Placebo: Participant Dropout Through Month 48 | Trial comparisons |
| Vaccine vs Placebo: HIV-1 Infections Diagnosed After Day 0 Including All Available Follow-up Through the Maximum Month 48 Visit | Trial comparisons |
| Vaccine vs Placebo: Participant Dropout Prior to Unblinding | Trial comparisons |
| Vaccine vs Placebo: Participant Dropout After Unblinding | Trial comparisons |
| Vaccine vs Placebo: HIV-1 Infections Diagnosed After Day 0 Through the Month 24 Visit | Trial comparisons |
| Vaccine vs Placebo: deaths from any cause | Trial comparisons |
| Vaccine vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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