A Phase IB Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA009-00-VP, Administered at 2 Different Dosing Schedules, in HIV-1-Uninfected Adult Participants
The worldwide HIV epidemic highlights the importance of developing an affordable, globally
successful vaccine for HIV prevention. The VRC-HIVDNA009-00-VP vaccine used in this study
was developed to incorporate HIV genes from multiple virus clades, representing the viral
subtypes responsible for about 90% of new HIV infections in the world. The purpose of this
study is to determine the safety and immunogenicity of VRC-HIVDNA009-00-VP in healthy, HIV
uninfected individuals.
Participants will be randomly assigned to one of three groups and will be followed for one
year. Study injections will be given by needle-free intramuscular injection at the start of
study and at Months 1 and 2. Group 1 will receive 3 injections of the study vaccine; Group
2 will receive 2 injections of the study vaccine (at start and Month 2) and injection of
placebo (at Month 1); Group 3 will receive 3 injections of placebo. After a screening visit,
study visits will occur at enrollment (initial injection) followed by 5 visits every 14 days
for the first 2.5 months, with three additional visits at Months 6, 9, and 12. All
participants will undergo physical exams, blood and urine tests to assess measures of
health, and blood tests to assess HIV infection and immune response to the injections.
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Julie McElrath
Study Chair
Fred Hutchinson Cancer Research Center / University of Washington
United States: Food and Drug Administration
HVTN 052
NCT00071851
December 2003
October 2005
Name | Location |
---|---|
Alabama Vaccine CRS | Birmingham, Alabama 35294 |
San Francisco Vaccine and Prevention CRS | San Francisco, California 94102 |
Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore | Baltimore, Maryland 21205 |
Project Brave HIV Vaccine CRS | Baltimore, Maryland 21201 |
Brigham and Women's Hosp. CRS | Boston, Massachusetts 02115 |
Fenway Community Health Clinical Research Site (FCHCRS) | Boston, Massachusetts 02215 |
NY Blood Ctr./Bronx CRS | Bronx, New York 10455 |
HIV Prevention & Treatment CRS | New York, New York 10032 |
NY Blood Ctr./Union Square CRS | New York, New York 10003 |
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 |