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
Public ClinicalTrials.gov record NCT00865566. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00865566
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 2,504 participants
Conditions and interventions
Conditions
Interventions
- DNA plasmid vaccine Biological
- Recombinant adenoviral serotype 5 (rAD5) vector vaccine Biological
- DNA vaccine placebo Biological
- HIV-1 recombinant adenovirus vaccine placebo Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- Male
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2009 (Type not available)
- Primary completion
- Oct 6, 2017 (Actual)
- Completion
- Oct 6, 2017 (Actual)
- Last update posted
- Oct 15, 2021
2009 – 2017
United States locations
- U.S. sites
- 22
- U.S. states
- 15
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama CRS | Birmingham | Alabama | 35294 | — |
| The AIDS Research Alliance of America CRS | Los Angeles | California | 90015 | — |
| UCLA CARE Center CRS | Los Angeles | California | 90035 | — |
| Bridge HIV CRS | San Francisco | California | 94143 | — |
| University of Colorado Hospital CRS | Aurora | Colorado | 80045 | — |
| Orlando Immunology Center CRS | Orlando | Florida | 32803 | — |
| The Hope Clinic of the Emory Vaccine Center CRS | Decatur | Georgia | 30030 | — |
| UIC Project WISH CRS | Chicago | Illinois | 60612 | — |
| VRC Clinical Trials Core CRS | Bethesda | Maryland | 20816 | — |
| Brigham and Women's Hospital Vaccine CRS (BWH VCRS) | Boston | Massachusetts | 02115-6110 | — |
| Fenway Health (FH) CRS | Boston | Massachusetts | 02215-4302 | — |
| NY Univ. HIV/AIDS CRS | New York | New York | 10016 | — |
| Columbia P&S CRS | New York | New York | 10032-3732 | — |
| New York Blood Center CRS | New York | New York | 10065 | — |
| University of Rochester Vaccines to Prevent HIV Infection CRS | Rochester | New York | 14642 | — |
| Case Clinical Research Site | Cleveland | Ohio | 44106 | — |
| Penn Prevention CRS | Philadelphia | Pennsylvania | 19104 | — |
| Vanderbilt Vaccine (VV) CRS | Nashville | Tennessee | 37232-2582 | — |
| University of Texas Southwestern CRS | Dallas | Texas | 75235 | — |
| Baylor Vaccine Research Center CRS | Houston | Texas | 77030 | — |
| Care-Id Crs | Annandale | Virginia | 22003 | — |
| Seattle Vaccine and Prevention CRS | Seattle | Washington | 98109-1024 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00865566, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 15, 2021 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00865566 live on ClinicalTrials.gov.