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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00013572
• Other study ID #: B011
• Secondary ID: RV 138
• Status: Active, not recruiting
• Phase: Phase 1
• First received: March 21, 2001
• Last updated: June 23, 2005

Study information

• Verified date: March 2003
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections
• HIV Seronegativity

Intervention

Biological:
• ALVAC-HIV MN120TMG (vCP205)

Locations

Country	Name	City	State
United States	Walter Reed Army Institute of Research (WRAIR)	Rockville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Walter Reed Army Institute of Research (WRAIR)

Country where clinical trial is conducted

United States,