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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2003 by NIH AIDS Clinical Trials Information Service. Recruitment status was Active, not recruiting

First Received on March 21, 2001. Last Updated on June 23, 2005 History of Changes

Sponsor:	Walter Reed Army Institute of Research (WRAIR)
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00013572

Purpose

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

Condition	Intervention	Phase
HIV Infections HIV Seronegativity	Biological: ALVAC-HIV MN120TMG (vCP205)	Phase I

Study Type:	Interventional
Study Design:	Primary Purpose: Prevention
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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency Help Me Understand Genetics

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00013572

Locations

United States, Maryland
Walter Reed Army Institute of Research (WRAIR)
Rockville, Maryland, United States, 20850

Sponsors and Collaborators

Walter Reed Army Institute of Research (WRAIR)

Investigators

Principal Investigator:

Mary Marovich

More Information

No publications provided by NIH AIDS Clinical Trials Information Service

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Eller MA, Slike BM, Cox JH, Lesho E, Wang Z, Currier JR, Darden JM, Polonis VR, Vahey MT, Peel S, Robb ML, Michael NL, Marovich MA. A double-blind randomized phase I clinical trial targeting ALVAC-HIV vaccine to human dendritic cells. PLoS One. 2011;6(9):e24254. Epub 2011 Sep 16.

ClinicalTrials.gov Identifier:	NCT00013572 History of Changes
Other Study ID Numbers:	B011, RV 138
Study First Received:	March 21, 2001
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Injections, Intramuscular
Injections, Intradermal
Injections, Subcutaneous
HIV-1
AIDS Vaccines
Dendritic Cells

HIV Seronegativity
Genes, env
Genes, pol
Genes, gag
Transfection
HIV Preventive Vaccine

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases

Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on February 12, 2012