A Study of AIDSVAX B/B and AIDSVAX B/E, Two Possible Vaccines
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.
Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
Biological: MN rgp120/HIV-1 and A244 rgp120/HIV-1
Biological: Aluminum hydroxide
|Study Design:||Endpoint Classification: Safety Study
Primary Purpose: Prevention
|Official Title:||Phase I/II Trial to Evaluate the Safety and Immunogenicity of AIDSVAX B/B and B/E Vaccines in the United States|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002402
|United States, Colorado|
|Dr Frank Judson / Director of Public Health Dept|
|Denver, Colorado, United States, 80204|
|United States, District of Columbia|
|Johns Hopkins Bloomberg School of Public Health|
|Washington, District of Columbia, United States, 20037|
|United States, Massachusetts|
|Fenway Community Health Ctr|
|Boston, Massachusetts, United States, 02115|
|United States, Missouri|
|Saint Louis Univ Health Sciences Ctr|
|Saint Louis, Missouri, United States, 63110|