A Study of AIDSVAX B/B and AIDSVAX B/E, Two Possible Vaccines
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00002402|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1 Biological: MN rgp120/HIV-1 and A244 rgp120/HIV-1 Biological: Aluminum hydroxide||Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Official Title:||Phase I/II Trial to Evaluate the Safety and Immunogenicity of AIDSVAX B/B and B/E Vaccines in the United States|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|