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A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects

HIV Infections Clinical Trial

Official title:
A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects

Clinical Trial Summary

To evaluate an HIV synthetic lipopeptide candidate vaccine component, P3C541b, at two dose levels, administered subcutaneously (s.c.) in a randomized, double-blind, placebo controlled study.

Clinical Trial Description

The prospective volunteers will be screened and HLA typed for Class I MHC haplotypes. Only volunteers possessing HLA alleles A33, B8, B27, B35 or Bw62 or any combination thereof will be enrolled in the study. Subjects will be allocated to 1 of 2 study groups. Group 1 will receive 70 mcg of P3C541b or the placebo and Group II will receive 350 mcg of P3C541b or the placebo. NOTE: Enrollment for Group II wil not begin until at least 5 Group I participants have reached day 14 without serious adverse events. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00000845
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Completed
Phase Phase 1
View Details
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