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.
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).
Study Type
INTERVENTIONAL
Purpose
PREVENTION
Enrollment
120
Dr Frank Judson / Director of Public Health Dept
Denver, Colorado, United States
Johns Hopkins Bloomberg School of Public Health
Washington D.C., District of Columbia, United States
Fenway Community Health Ctr
Boston, Massachusetts, United States
Saint Louis Univ Health Sciences Ctr
St Louis, Missouri, United States
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