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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00013572
Recruitment Status : Unknown
Verified March 2003 by NIH AIDS Clinical Trials Information Service.
Recruitment status was:  Active, not recruiting
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

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

Condition or disease Intervention/treatment Phase
HIV Infections HIV Seronegativity Biological: ALVAC-HIV MN120TMG (vCP205) Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 36 participants
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 the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00013572


Locations
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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
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Principal Investigator: Mary Marovich
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00013572    
Other Study ID Numbers: B011
RV 138
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: March 2003
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:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
 Retroviridae Infections
RNA Virus Infections
Virus Diseases
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases