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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00091416 |
The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine, VRC-HIVADV014-00-VP, when given as a vaccine booster to HIV uninfected adults who participated in HVTN 052.
Condition | Intervention | Phase |
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HIV Infections |
Biological: VRC-HIVADV014-00-VP |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Phase I Clinical Trial to Evaluate the Safety of a Multiclade Recombinant Adenoviral Vector HIV-1 Vaccine Administered to Healthy, HIV-1 Uninfected, Adult Participants Who Received DNA Plasmid Vaccine or Placebo in the HVTN 052 Clinical Trial |
Estimated Enrollment: | 70 |
The worldwide HIV epidemic highlights the importance of developing an affordable, globally successful vaccine for HIV prevention. The VRC-HIVADV014-00-VP adenoviral vector vaccine used in this study was developed to stimulate strong virus-specific CD8 cytotoxic T-lymphocyte (CTL) responses thought to be crucial in an effective preventive HIV vaccine. The purpose of this study is to determine the safety and immunogenicity of a VRC-HIVADV014-00-VP vaccine boost given to healthy, HIV uninfected individuals who participated in HVTN 052, which evaluated the VRC-HIVDNA009-00-VP DNA plasmid vaccine. In that study, participants received either 3 injections of vaccine, 2 injections of vaccine and 1 injection of placebo, or 3 injections of placebo over a 2-month period.
This study will last one year. Participants will be randomly assigned to receive vaccine boost or placebo by intramuscular injection. The injections will be given 6 to 9 months after each participant's first HVTN 052 study injection, preferably as close to 6 months after the first HVTN 052 injection as possible. After a screening visit, study visits will occur at enrollment (when the injection will be given), at Week 2, and at Months 1, 3, 6, and 12. Blood collection, physical exam, and medication assessment will occur at every study visit; urine collection will occur at selected visits.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294-2041 | |
United States, California | |
San Francisco Department of Public Health | |
San Francisco, California, United States, 94102-6033 | |
Mt. Zion Hospital - GCRC | |
San Francisco, California, United States, 94102-6033 | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21205-1901 | |
JHU-CIR/DC | |
Baltimore, Maryland, United States, 21205-1901 | |
United States, Massachusetts | |
Fenway Community Health | |
Boston, Massachusetts, United States, 02115 | |
United States, Missouri | |
St. Louis University - New Hope Bldg. | |
St Louis, Missouri, United States, 63110-2500 | |
United States, New York | |
University of Rochester | |
Rochester, New York, United States, 14642-0001 | |
New York Blood Center - Union Square | |
New York, New York, United States, 10003 | |
New York Blood Center - Bronx | |
Bronx, New York, United States, 10456 | |
Columbia University | |
New York, New York, United States, 10032 | |
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37232 | |
United States, Washington | |
FHCRC/UW - Vaccine Trials Unit | |
Seattle, Washington, United States, 98104 |
Study Chair: | Larry Peiperl, MD | San Francisco Department of Public Health / University of California - San Francisco |
Study Chair: | Julie McElrath, MD, PhD | Fred Hutchinson Cancer Research Center / University of Washington |
Study ID Numbers: | HVTN 057 |
Study First Received: | September 8, 2004 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00091416 |
Health Authority: | United States: Food and Drug Administration |
HIV Seronegativity HIV Preventive Vaccine |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Healthy Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |