This study will evaluate the safety and preliminary immune response to recombinant adenoviral serotype 35 and 5 HIV-1 vaccines in HIV-uninfected adults.
One of the more promising approaches in the development of a preventive HIV vaccine uses a DNA plasmid to prime the immune response to an adenoviral vector boost. This primary purpose of this study is to evaluate the safety, tolerability, and immune response to recombinant adenoviral serotype 35 (rAd35) and serotype 5 (rAD5) HIV-1 vaccines in Ad-5 naive and Ad-5 exposed HIV-uninfected adults. This study will last approximately 12 months. Participants will include those who are both rAD5-naive and rAD5-exposed and will be stratified into one of four groups. Each group will consist of two arms, one interventional and one control. Participants in Groups 1, 2, and 3 will be rAD5-naive. Participants in Group 4 will be rAD5-exposed. Participants in Group 1 will receive an injection of rAD35 vaccine or placebo at study entry and an injection of rAD5 vaccine or placebo at Month 6 with nine follow-up visits through Month 12. Participants in Groups 2, 3, and 4 will injections of DNA vaccinations or placebo at study entry and at Months 1 and 2, and an injection of rAD35 vaccine, rAD5 vaccine, or placebo at Month 6 with twelve follow-up visits though Month 12. A physical, questionnaire, and counseling will occur at all visits. Blood and urine collection will occur at most visits. A rectal swab will occur at selected visits. For females, a pregnancy test will occur at all visits. Participants will be contacted for safety follow-ups after the injection every year for 5 years. Health and adverse events will be recorded. Participants will not need to return to the study clinic unless HIV confirmatory testing is needed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
192
4 mg VRC-HIVDNA044-00-VP administered as 1 mL
1 mL VRC-PBSPLA043-00-VP
VRC-HIVADV027-00-VP 1 x 10\^10 PU administered as 1 mL
Alabama CRS
Birmingham, Alabama, United States
Bridge HIV CRS
San Francisco, California, United States
The Hope Clinic of the Emory Vaccine Center CRS
Decatur, Georgia, United States
Local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and expedited adverse events
Time frame: Throughout study
Magnitude and frequency of immune responses between HIV-1 clade A env rAD35 and rAd5 vaccines when given as a boost after DNA vaccine
Time frame: At Week 4 following the fourth vaccination
Magnitude and frequency of immune responses between clade A env rAD35 vaccine primed by Ad35 versus DNA
Time frame: At Week 4 following the last vaccination
Magnitude and frequency of immune responses of HIV-1 clade A env rAD35 vaccine when given as a boost
Time frame: At Week 4 following the fourth vaccination
Immunogenicity of HIV-1 clade A env rAD35 vaccine given as a prime
Time frame: At Week 4 following the first vaccination
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1 mL VRC-PBSPLA043-00-0VP
4 mg VRC-HIVADV038-00-VP administered as 1 mL
1 mL VRC-DILUENT013-DIL-VP
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, United States
Fenway Health (FH) CRS
Boston, Massachusetts, United States
Columbia P&S CRS
New York, New York, United States
New York Blood Center CRS
New York, New York, United States
University of Rochester Vaccines to Prevent HIV Infection CRS
Rochester, New York, United States
Vanderbilt Vaccine (VV) CRS
Nashville, Tennessee, United States
Seattle Vaccine and Prevention CRS
Seattle, Washington, United States