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


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AIDS and HIV

 




Clinical Trial: HIV Candidate Vaccine, ALVAC-HIV-1, Administration in HIV-Negative Adults

This study is no longer recruiting patients.

Sponsored by: Walter Reed Army Institute of Research (WRAIR)
Information provided by: AIDS Clinical Trials Information Service

Purpose

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

Condition Treatment or Intervention Phase
HIV Infections
HIV Seronegativity
 Vaccine: ALVAC-HIV MN120TMG (vCP205)
Phase I

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: 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

Further Study Details: 

Expected Total Enrollment:  36

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   -   55 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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.

Location Information


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

Study chairs or principal investigators

Mary Marovich,  Principal Investigator

More Information

Study ID Numbers:  B011; RV 138
Record last reviewed:  March 2003
Last Updated:  October 13, 2004
Record first received:  March 21, 2001
ClinicalTrials.gov Identifier:  NCT00013572
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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December 3, 2009



Page Updated: May 11, 2006
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