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A Phase I Safety and Immunogenicity Trial of UBI SynVac (HIV-1 MN Octameric V3 Peptide Vaccine)

HIV Infections Clinical Trial

Official title:
A Phase I Safety and Immunogenicity Trial of UBI SynVac (HIV-1 MN Octameric V3 Peptide Vaccine)

Clinical Trial Summary

To determine the safety, immunogenicity, and optimal dose of rgp120/HIV-1MN octameric V3 peptide vaccine (SynVac) in healthy volunteers.

It is likely that the ultimate control of AIDS will depend on the development of safe and effective vaccines against HIV-1. SynVac is a synthetic candidate vaccine based on eight V3-derived peptides attached to a heptalysyl core to form radial octamers. In animal studies, the vaccine appears safe and demonstrates the capability for producing immune responses.

Clinical Trial Description

It is likely that the ultimate control of AIDS will depend on the development of safe and effective vaccines against HIV-1. SynVac is a synthetic candidate vaccine based on eight V3-derived peptides attached to a heptalysyl core to form radial octamers. In animal studies, the vaccine appears safe and demonstrates the capability for producing immune responses.

Twelve volunteers are entered at one of three dose levels of SynVac. At each dose level, 10 volunteers receive vaccine and two receive placebo. At least eight volunteers at each dose level must be monitored for 1 week before subsequent volunteers are entered at the next higher level. Intramuscular injections are given on day 0, 28, and 168. Approximately 12 clinic visits are required. ;

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00000775
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Completed
Phase Phase 1
View Details
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