NCT00002402

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

Phase I/II Trial to Evaluate the Safety and Immunogenicity of AIDSVAX B/B and B/E Vaccines in the United States

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (planned)
• Sponsor: VaxGen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
BIOLOGICAL	MN rgp120/HIV-1 and A244 rgp120/HIV-1
BIOLOGICAL	Aluminum hydroxide

Timeline

• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

4 sites across 1 country: United States