IPCAVD 002

Status:Completed
Phase:I
Principal Investigator(s):Lindsey Baden, MD; Dan Barouch, MD
Objective:To determine the safety of and immune response to an adenovirus serotype HIV vaccine in HIV uninfected adults.last updated March 30, 2021
Prevention Option(s):HIV Vaccine
Study Design:Controlled, Double-blind, Placebo, Randomized
Arms and Assigned Interventions
Description3 injections of rAd5.ENVA.48 HIV-1 vaccine or placebo at 1 x 10^9 virus particles (VP) given at Days 0, 28, and 168
Mode of DeliveryIntramuscular
ARMsExperimental
Description3 injections of rAd5.ENVA.48 HIV-1 vaccine or placebo at 1 x 10^10 virus particles (VP) given at Days 0, 28, and 168
Mode of DeliveryIntramuscular
ARMsExperimental
Description3 injections of rAd5.ENVA.48 HIV-1 vaccine or placebo at 1 x 10^11 virus particles (VP) given at Days 0, 28, and 168
Mode of DeliveryIntramuscular
ARMsExperimental
Description1 injection of rAd5.ENVA.48 HIV-1 vaccine or placebo at a dose determined by the safety data from Arms 1, 2 and 3 given at Day 0.
Mode of DeliveryIntramuscular
ARMs
Results: Safety and immunogenicity of a replication-incompetent adenovirus type 5 HIV-1 clade B gag/pol/nef vaccine in healthy adults
Official Code: NCT00695877
Related Publications:
Baseline morbidity in 2,990 adult African volunteers recruited to characterize laboratory reference intervals for future HIV vaccine clinical trials
First-in-human evaluation of a hexon chimeric adenovirus vector expressing HIV-1 Env (IPCAVD 002)
Trial Sponsors: NIAID
Start Date
End Date
February 1, 2009
December 31, 2012
Enrollment:48
Age range: 18 Years ↔ 50 Years
Population:Cisgender Men, Cisgender Women