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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Larry Peiperl, MD
Study Chair
San Francisco Department of Public Health / University of California - San Francisco
United States: Food and Drug Administration
HVTN 057
NCT00091416
May 2006
Name | Location |
---|---|
Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore | Baltimore, Maryland 21205 |
Fenway Community Health Clinical Research Site (FCHCRS) | Boston, Massachusetts 02215 |
HIV Prevention & Treatment CRS | New York, New York 10032 |
Univ. of Rochester HVTN CRS | Rochester, New York 14642 |
Miriam Hospital's HVTU | Providence, Rhode Island 02906 |
Vanderbilt Vaccine CRS | Nashville, Tennessee 37232 |
FHCRC/UW Vaccine CRS | Seattle, Washington 98104 |
Saint Louis Univ. School of Medicine, HVTU | St Louis, Missouri 63110-2500 |