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A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults

HIV Infections Clinical Trial

Official title:
A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults

Clinical Trial Summary

To evaluate the safety and tolerability of the Chiron vaccine human immunodeficiency virus (HIV) p24(25 or 50 micrograms)/MF59 in healthy HIV-1 seronegative adults. To evaluate the immunogenicity of the HIV p24(50 micrograms)/MF59 vaccine.

Clinical Trial Description

This study evaluates the safety and immunogenicity of the Chiron vaccine HIV p24/MF59. In Part A, 15 volunteers are randomly assigned to receive either HIV p24/MF59 or a placebo at 0, 1, and 6 months. 10 volunteers receive the vaccine and 5 volunteers receive the placebo. If no serious adverse events are observed within 1 week after the first injection in these first 15 patients, Part B is initiated. In Part B, 25 volunteers are randomly assigned to receive HIV p24/MF59 or a placebo at 0, 1, and 6 months. 20 volunteers receive the vaccine and 5 volunteers receive the placebo. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00002204
Study type Interventional
Source NIH AIDS Clinical Trials Information Service
Contact
Status Completed
Phase Phase 1
View Details
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