HIV Candidate Vaccine, ALVAC-HIV-1, Administration in HIV-Negative Adults

Phase 1

• Conditions: HIV Infections; HIV Seronegativity

• Registration Number: NCT00013572
• Lead Sponsor: Walter Reed Army Institute of Research (WRAIR)

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2001-03-21
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2003-03
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Walter Reed Army Institute of Research (WRAIR); 🇺🇸 Rockville, Maryland, United States