HVTN 077
Status:Completed
Phase:I
Principal Investigator(s):Jonathan Fuchs, MD, MPH & Pierre-Alexandre Bart, MD
Objective:This study will evaluate the safety and preliminary immune response to recombinant adenoviral serotype 35 and 5 HIV-1 vaccines in HIV-uninfected adults.last updated March 30, 2021
Prevention Option(s):HIV Vaccine
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
DescriptionrAD5-naive participants will receive rAd35 intramuscularly at study entry and rAd5 intramuscularly at Month 6.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive rAd35 placebo intramuscularly at study entry and rAd5 placebo intramuscularly at Month 6.
Mode of DeliveryIntramuscular
ARMsPlacebo Comparator
DescriptionrAD5-naive participants will receive DNA vaccine intramuscularly at study entry and Months 1 and 2 and rAd5 intramuscularly at Month 6.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive DNA vaccine intramuscularly at study entry and Months 1 and 2 and rAd35 intramuscularly at Month 6.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive DNA vaccine intramuscularly at study entry and Months 1 and 2 and rAd35 intramuscularly at Month 6.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive DNA vaccine placebo intramuscularly at study entry and Months 1 and 2 and rAd35 placebo intramuscularly at Month 6.
Mode of DeliveryIntramuscular
ARMsPlacebo Comparator
Official Code:
NCT00801697
Trial Sponsors:
HIV Vaccine Trials Network, National Institute of Allergy and Infectious Diseases (NIAID)
Start Date
End Date
February 28, 2009
April 1, 2015
Enrollment:192
Age range:
18 Years ↔
50 Years
Population: