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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002402

Enrollment

120

Registered

2001-08-31

Start date

Unknown

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV-1, Dose-Response Relationship, Drug, Acquired Immunodeficiency Syndrome, AIDS Vaccines, HIV Seronegativity, Antigens, Viral, Alum Compounds

Brief 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).

Interventions

BIOLOGICALMN rgp120/HIV-1 and GNE8 rgp120/HIV-1

BIOLOGICALMN rgp120/HIV-1 and A244 rgp120/HIV-1

BIOLOGICALAluminum hydroxide

Study design

Primary purpose

PREVENTION

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026