NCT00223080

HIV Vaccine Trial in Thai Adults

A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC-HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX B/E) Boosting in HIV-uninfected Thai Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 16,402 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether immunizations with an integrated combination of ALVAC-HIV (vCP1521) boosted by AIDSVAX gp120 B/E prevent HIV infection in healthy Thai volunteers.

Detailed description

A vaccine for the prevention of HIV infection remains an urgent need as part of the efforts to control the HIV pandemic. In this phase III efficacy trial, a 'prime-boost' vaccine strategy is evaluated for prevention of infection and amelioration of disease course. ALVAC-HIV (vCP1521) from sanofi pasteur is given as the 'prime' vaccine at months 0, 1, 3 and 6; AIDSVAX gp120 B/E from VaxGen is given as the 'boost' at months 3 and 6. This regimen will be given to 8,000 adult Thai subjects, while another 8,000 will be given placebos in a double-blinded, randomized manner. Following the completion of each subjects immunization phase, he/she will be followed for 3 years with clinic visits every 6 months with HIV testing, pre- and post-test counseling. Subjects who become HIV infected will be counseled, referred to HIV treatment facilities for management according to national guidelines, and offered enrollment in a protocol for extended follow-up.

Conditions

• HIV Infection

Interventions

Type	Name	Description
BIOLOGICAL	ALVAC-HIV vCP1521 + AIDSVAX	Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL
OTHER	ALVAC Placebo + AIDSVAX Placebo	ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection

Timeline

• Start date: 2003-10-01
• Primary completion: 2006-07-01
• Completion: 2009-06-01
• First posted: 2005-09-22
• Last updated: 2019-04-24
• Results posted: 2018-10-19

Locations

8 sites across 1 country: Thailand