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

NCT ID: NCT00002402

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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).

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

PREVENTION

Interventions

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MN rgp120/HIV-1 and GNE8 rgp120/HIV-1

Intervention Type BIOLOGICAL

MN rgp120/HIV-1 and A244 rgp120/HIV-1

Intervention Type BIOLOGICAL

Aluminum hydroxide

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

Patients must:

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VaxGen

INDUSTRY

Sponsor Role lead

Locations

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Dr Frank Judson / Director of Public Health Dept

Denver, Colorado, United States

Site Status

Johns Hopkins Bloomberg School of Public Health

Washington D.C., District of Columbia, United States

Site Status

Fenway Community Health Ctr

Boston, Massachusetts, United States

Site Status

Saint Louis Univ Health Sciences Ctr

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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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)

Reference Type BACKGROUND

Other Identifiers

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VAX 002

Identifier Type: -

Identifier Source: org_study_id