NCT00002441

Effectiveness of an HIV Vaccine in HIV-Negative Adults in North America Who Are at Risk of HIV Infection

A Phase III Trial to Determine the Efficacy of Bivalent AIDSVAX B/B Vaccine in Adults at Risk of Sexually Transmitted HIV-1 Infection in North America

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,000 (planned)
• Sponsor: VaxGen · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to see if an HIV vaccine, AIDSVAX B/B, can protect adults who are at risk from becoming infected with HIV. Patients who become infected despite immunization will be studied to see if receiving the vaccine before becoming infected will help keep HIV levels (viral load) low.

Detailed description

Volunteers receive 7 blinded, intramuscular vaccinations (at Months 0, 1, 6, 12, 18, 24, 30) containing either the AIDSVAX B/B vaccine or a placebo (aluminum adjuvant only). Volunteers are randomized in a 2 to 1 vaccine-to-placebo ratio. HIV-uninfected persons are followed for a total of 16 visits beginning at screening and continuing until Month 36. Patients who become HIV infected during study are followed every 4 months for at least 24 months.

Conditions

• HIV Infections
• HIV Seronegativity

Interventions

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

Timeline

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

Locations

67 sites across 4 countries: United States, Canada, Netherlands, Puerto Rico