IPCAVD 001

Status:Completed
Phase:I
Principal Investigator(s):Lindsey Baden, MD, Dan Barouch, MD, PhD, Raphael Dolin, MD
Objective:The purpose of this study is to determine the safety of and immune response to an adenovirus serotype HIV vaccine in HIV uninfected adults. Results: This Ad26 vectored vaccine was generally safe and immunogenic at all doses tested. Reactogenicity was minimal with doses of 5 × 10(10) vp or less. Ad26 is a promising new vaccine vector for HIV-1.
Prevention Option(s):HIV Vaccine
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
Description3 injections of Ad26.ENVA.01 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 Ad26.ENVA.01 HIV-1 vaccine or placebo at 1 x 10^10 VP given at Days 0, 28, and 168
Mode of DeliveryIntramuscular
ARMsExperimental
Description3 injections of Ad26.ENVA.01 HIV-1 vaccine or placebo at 1 x 10^11 VP given at Days 0, 28, and 168
Mode of DeliveryIntramuscular
ARMsExperimental
Description2 injections of Ad26.ENVA.01 HIV-1 vaccine or placebo at a dose to be determined by the safety data from Arms 1, 2 and 3 given at Days 0 and 168
Mode of DeliveryIntramuscular
ARMsExperimental
Results: First-in-Human Evaluation of the Safety and Immunogenicity of a Recombinant Adenovirus Serotype 26 HIV-1 Env Vaccine
Official Code: NCT00618605
Trial Sponsors: NIAID
Start Date
End Date
February 22, 2008
June 22, 2011
Enrollment:60
Age range: 18 Years ↔ 50 Years
Population:Cisgender Men, Cisgender Women, Injecting drug users