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

Tracking Information

First Received Date ^ICMJE

March 21, 2001

Last Updated Date

June 23, 2005

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00013572 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention

Condition ^ICMJE

HIV Infections
HIV Seronegativity

Intervention ^ICMJE

Biological: ALVAC-HIV MN120TMG (vCP205)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00013572

Responsible Party

Study ID Numbers ^ICMJE

B011, RV 138

Study Sponsor ^ICMJE

Walter Reed Army Institute of Research (WRAIR)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Mary Marovich

Information Provided By

NIH AIDS Clinical Trials Information Service

Verification Date

March 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP