Trials / Unknown
UnknownNCT01931358
Study of Boosting Strategies After Vaccination With ALVAC-HIV and AIDSVAX® B/E
Randomized, Double Blind Evaluation of Different One-Year Boosts After Sanofi Pasteur Live Recombinant ALVAC-HIV (vCP1521) and Global Solutions for Infectious Diseases (GSID) gp120 B/E (AIDSVAX® B/E) Prime-Boost Regimen in HIV-uninfected Thai Adults
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- Sponsor
- U.S. Army Medical Research and Development Command · Federal
- Sex
- All
- Age
- 20 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
The primary purpose of the study is to better define the relative contributions of AIDSVAX® B/E alone, ALVAC-HIV alone, or ALVAC-HIV plus AIDSVAX® B/E combination to the observed immune profile in the weeks and months after receiving the original prime and boost vaccine regimen from study protocol RV 144, and their booster effects in both the systemic and mucosal compartments. In addition, this study will provide more intensive and comprehensive characterization of the innate, cell-mediated and humoral immune responses than possible within the RV 144 study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ALVAC-HIV | 1 mL intramuscular injection containing 10\^6 CCID50/dose |
| BIOLOGICAL | AIDSVAX B/E | 1 mL per injection (300 ug dose/antigen for a total of 600ug/dose administered) |
| BIOLOGICAL | ALVAC-HIV Placebo | 1 mL per injection |
| BIOLOGICAL | AIDSVAX B/E Placebo | 1 mL per injection |
Timeline
- Start date
- 2013-09-24
- Primary completion
- 2021-12-01
- Completion
- 2021-12-01
- First posted
- 2013-08-29
- Last updated
- 2021-03-26
Locations
3 sites across 1 country: Thailand
Source: ClinicalTrials.gov record NCT01931358. Inclusion in this directory is not an endorsement.