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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
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00013572
First received: March 21, 2001
Last updated: June 23, 2005
Last verified: March 2003

March 21, 2001
June 23, 2005
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Complete list of historical versions of study NCT00013572 on ClinicalTrials.gov Archive Site
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HIV Candidate Vaccine, ALVAC-HIV-1, Administration in HIV-Negative Adults
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

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

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.

Interventional
Phase 1
Primary Purpose: Prevention
  • HIV Infections
  • HIV Seronegativity
Biological: ALVAC-HIV MN120TMG (vCP205)
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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. doi: 10.1371/journal.pone.0024254. Epub 2011 Sep 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
36
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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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00013572
B011, RV 138
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Walter Reed Army Institute of Research (WRAIR)
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Principal Investigator: Mary Marovich
NIH AIDS Clinical Trials Information Service
March 2003

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