A Study of AIDSVAX B/B and AIDSVAX B/E, Two Possible Vaccines - Full Text View

Sponsor:	VaxGen
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002402

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 I

Study Type:	Interventional
Study Design:	Prevention, Dose Comparison, Safety Study
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:

MedlinePlus related topics: AIDS

Drug Information available for: Aluminum hydroxide Algeldrate Aluminum

U.S. FDA Resources

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

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)

Study ID Numbers:	VAX 002
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002402 History of Changes
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:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Physiological Effects of Drugs
Acquired Immunodeficiency Syndrome
Adjuvants, Immunologic
Infection

Pharmacologic Actions
Immunologic Deficiency Syndromes
Aluminum Hydroxide
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Antacids
Retroviridae Infections

ClinicalTrials.gov processed this record on November 22, 2009