A Study of AIDSVAX B/B and AIDSVAX B/E, Two Possible Vaccines
- Conditions
- HIV Infections
- Registration Number
- NCT00002402
- Lead Sponsor
- VaxGen
- Brief Summary
The purpose of this study is to see if it is safe and effective to give AIDSVAX B/B or AIDSVAX B/E, two potential HIV vaccines, to HIV-negative volunteers.
- Detailed Description
Patients are randomized to 1 of the 2 following arms and administered 1 or 2 injections into the deltoid muscle at 0, 1, 6, and 12 months:
Arm A: Patients receive 1 of 3 doses of AIDSVAX B/B vaccine (MN rgp120/HIV-1 plus GNE8 rgp120/HIV-1) in alum adjuvant.
Arm B: Patients receive AIDSVAX B/E (MN rgp120/HIV-1 plus A244 rgp120/HIV-1) vaccine in alum adjuvant.
Patients are evaluated at 1 hr, 3 days, and 14 days after each immunization and at 18 months after the first immunization.
An interim analysis is performed after all patients receive the second dose (at 1 month).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Fenway Community Health Ctr
🇺🇸Boston, Massachusetts, United States
Dr Frank Judson / Director of Public Health Dept
🇺🇸Denver, Colorado, United States
Saint Louis Univ Health Sciences Ctr
🇺🇸Saint Louis, Missouri, United States
Johns Hopkins Bloomberg School of Public Health
🇺🇸Washington, District of Columbia, United States