Overview

This trial is active, not recruiting.

Conditions hiv infections, hiv seronegativity
Treatment alvac-hiv mn120tmg (vcp205)
Phase phase 1
Sponsor Walter Reed Army Institute of Research (WRAIR)
Trial size 36 participants
Trial identifier NCT00013572, B011, RV 138

Summary

The purpose of this study is to determine the best way to administer the candidate HIV vaccine, ALVAC HIV-1 (vCP205).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose prevention

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria Volunteers may be eligible for this study if they: - Are legal US residents. - Are healthy adults from 18 to 55 years of age. Exclusion Criteria Volunteers will not be eligible for this study if they: - Are HIV-positive. - Are at highest risk for HIV infection. - Are pregnant or breast-feeding. - Are allergic to eggs or neomycin. - Use certain prescription medications.

Additional Information

Official title A Phase I Study of Aventis Pasteur Live Recombinant ALVAC-HIV (vCP205, HIV-1 Env/Gag/Pol) in Seronegative Adults Administered (1) Subcutaneously Via Ex Vivo Transfected, Autologous Dendritic Cells, (2) Intradermally, or (3) Intramuscularly
Principal investigator Mary Marovich
Description Healthy adult volunteers are assigned randomly to either a vaccine or placebo group. Injections are received either intramuscularly, intradermally, or by delivery under the skin of the volunteer's own white blood cells which have had dendritic cell reinfusion. Volunteers are vaccinated at 0, 1, 3, and 6 month time points. Volunteers are closely monitored for 1 hour after vaccination and keep a diary of symptoms for 1 week post-immunization. Volunteers undergo leukopheresis at the start of the study and after the last vaccination at Walter Reed Army Medical Center. Volunteers receive compensation benefits.
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by NIH AIDS Clinical Trials Information Service.