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
  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 1

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:


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

Estimated Enrollment: 36
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 30, 2014