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

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.