HVTN 085
Status:Completed
Phase:Ib
Principal Investigator(s):Ian Frank
Objective:To evaluate the immune response to the Vaccine Research Center (VRC) rAd5 HIV vaccine when the vaccine components are administered in three different ways, in healthy, HIV-uninfected adults.
*Trial is in follow-up*
Prevention Option(s):HIV Vaccine
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
DescriptionParticipants will receive the VRC rAd5 gag-pol/env A/B/C vaccine injection in their right arm (1×10^10 PU), and placebo vaccine injections in their left arm, right thigh, and left thigh.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive the rAd5 gag-pol vaccine injection in their right arm (0.5×10^10 PU), the rAd5 env A vaccine injection in their left arm (0.17×10^10 PU), the rAd5 env B vaccine injection in their right thigh (0.17×10^10 PU), and the rAd5 env C vaccine injection in their left thigh (0.17×10^10 PU).
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive the VRC rAd5 gag-pol/env A/B/C vaccine injection divided into fourths, with one fourth of the total dose given in each of 4 sites: right arm, left arm, right thigh, and left thigh (each at 0.25×10^10 PU).
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code:
NCT01479296
Trial Sponsors:
NIAID
Start Date
End Date
December 31, 2011
November 9, 2017
Enrollment:90
Age range:
18 Years ↔
50 Years
Population:Cisgender Men, Cisgender Women