A Study of AIDSVAX B/B and AIDSVAX B/E, Two Possible Vaccines

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002402
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 1998

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002402 on ClinicalTrials.gov Archive Site
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A Study of AIDSVAX B/B and AIDSVAX B/E, Two Possible Vaccines
Phase I/II Trial to Evaluate the Safety and Immunogenicity of AIDSVAX B/B and B/E Vaccines in the United States

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).

Interventional
Phase 1
Endpoint Classification: Safety Study
Primary Purpose: Prevention
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
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Mayer K, Judson F, Gorse G, Harro C, Peterson M, Zaharias E, Good J, Shibata R, Lee S, Eastman D, Chernow M, Francis D, Berman P. A phase I/II trial to evaluate the safety and immunogenicity of the AIDSVAX B/B vaccine in the United States (final report). 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 178)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
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Patients must:

Be HIV-uninfected men and women at low or intermediate risk for HIV-1 infection.

Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002402
VAX 002
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VaxGen
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NIH AIDS Clinical Trials Information Service
August 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP