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
  Purpose

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.


Condition Intervention 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

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 120
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Patients must:

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002402

Locations
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
Sponsors and Collaborators
VaxGen
  More Information

Publications:
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)

ClinicalTrials.gov Identifier: NCT00002402     History of Changes
Other Study ID Numbers: VAX 002
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1
Dose-Response Relationship, Drug
Acquired Immunodeficiency Syndrome
AIDS Vaccines
HIV Seronegativity
Antigens, Viral
Alum Compounds

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Aluminum Hydroxide
Adjuvants, Immunologic
Antacids
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014