A Phase I Clinical Trial to Evaluate Immune Response Kinetics and Safety of Two Different Primes, Adenoviral Vector Vaccine (VRC-HIVADV014-00-VP) and DNA Vaccine (VRC-HIVDNA009-00-VP), Each Followed by Adenoviral Vector Boost in Healthy, HIV-1 Uninfected Adults
Evaluating the immunogenicity of HIV vaccines is critical to improving vaccine design and
development. The adenoviral vector HIV vaccine VRC-HIVADV014-00-VP has shown immunogenicity
in early studies and appeared safe and well tolerated at three different doses in a prior
dose-escalation vaccine trial in HIV uninfected adults. The DNA HIV vaccine
VRC-HIVDNA009-00-VP has shown immunogenicity in multiple clinical trials; in one trial, the
DNA vaccine demonstrated a nearly 100% CD4 T-cell response rate. The DNA plasmids in both
vaccines code for proteins from HIV subtypes A, B, and C, which together represent 90% of
new HIV infections. This study will determine the safety and immune response to the
administration of an adenoviral vector HIV vaccine or a DNA HIV vaccine, each followed by an
adenoviral vaccine boost, in HIV uninfected adults.
This study will last 1 year. Participants will be randomly assigned to one of two groups.
Within each group, participants will be randomly assigned to receive either vaccine or
control injections. Group 1 participants will receive either placebo or the adenoviral HIV
vaccine at study entry and Month 6. Group 2 participants will receive either placebo or the
DNA HIV vaccine at study entry and Month 1 and the adenoviral HIV vaccine at Month 6.
Participants will be asked to record their temperatures and other side effects in a symptom
log on the day of each vaccination and for 3 days thereafter to report any side effects.
Group 1 participants will have 16 study visits, and a physical exam and HIV and pregnancy
prevention counseling will occur at each visit. Participants will also be asked about any
side effects and medications they are taking. Blood collection will occur at most visits.
Urine collection will occur at selected visits. Participants will be asked to complete a
social impact assessment at Months 2, 6, and 12 and a testing and belief questionnaire at
Months 6 and 12.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Safety (local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse and serious experiences)
After each injection and for 6 months after the last injection
Stephen De Rosa, MD
Fred Hutchinson Cancer Research Center and University of Washington
United States: Food and Drug Administration
|Alabama Vaccine CRS||Birmingham, Alabama 35294|
|San Francisco Vaccine and Prevention CRS||San Francisco, California 94102|
|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|
|Vanderbilt Vaccine CRS||Nashville, Tennessee 37232|
|FHCRC/UW Vaccine CRS||Seattle, Washington 98104|