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

V

VaxGen

Status and phase

Completed
Phase 1

Conditions

HIV Infections

Treatments

Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
Biological: Aluminum hydroxide
Biological: MN rgp120/HIV-1 and A244 rgp120/HIV-1

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002402
VAX 002

Details and patient eligibility

About

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.

Full 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).

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Patients must:

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

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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