IAVI B002

Status:Completed
Phase:I
Principal Investigator(s):Gloria Susan Omosa-Manyonyi, MBChB,DPH,DLSHTM, MSc.
Objective:The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of an adjuvanted GSK investigational HIV vaccine and Ad35-GRIN in 4 different regimens at months 1, 2, 3, and 4.last updated March 30, 2021
Prevention Option(s):HIV Vaccine
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
DescriptionAdjuvanted GSK investigational HIV vaccine at Months 0 and 1 followed by Ad35-GRIN investigational HIV vaccine at Month 4.
Mode of Delivery
ARMsExperimental
DescriptionAdjuvanted GSK investigational HIV vaccine at Months 0 and 1 followed by Ad35-GRIN investigational HIV vaccine at Month 4.
Mode of Delivery
ARMsExperimental
DescriptionAd35-GRIN investigational HIV vaccine at Month 0 followed by Adjuvanted GSK investigational HIV vaccine at Months 3 and 4.
Mode of Delivery
ARMsExperimental
DescriptionAdjuvanted GSK investigational HIV vaccine and Ad35-GRIN investigational HIV vaccine co-administered (simultaneous administration with separate injections)at Months 0, 1, and 4.
Mode of Delivery
ARMsExperimental
Results: A Phase I Double Blind, Placebo-Controlled, Randomized Study of the Safety and Immunogenicity of an Adjuvanted HIV-1 Gag-Pol-Nef Fusion Protein and Adenovirus 35 Gag-RT-Int-Nef Vaccine in Healthy HIV-
Official Code: NCT01264445
Trial Sponsors: GSK, IAVI
Start Date
End Date
February 1, 2011
November 30, 2012
Enrollment:147
Age range: 18 Years ↔ 40 Years
Population:Cisgender Men, Cisgender Women