IAVI A002

Status:Completed
Phase:II
Principal Investigator(s):Eftyhia Vardas
Objective:Evaluate the safety, immunogenicity and optimal timing of two injections at three dose levels of the tgAAC09 vaccine in healthy volunteers   Last updated March 31, 2021
Prevention Option(s):HIV Vaccine
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
DescriptiontgAAC09 (3 x 10^10 DRP) at months 0 and 6
Mode of Delivery
ARMsExperimental
DescriptiontgAAC09 (3 x 10^10 DRP) at months 0 and 12
Mode of Delivery
ARMsExperimental
DescriptiontgAAC09 (3 x 10^11 DRP) at months 0 and 6
Mode of Delivery
ARMsExperimental
DescriptiontgAAC09 (3 x 10^11 DRP) at months 0 and 12
Mode of Delivery
ARMsExperimental
DescriptiontgAAC09 (3 x 10^12 DRP) at months 0 and 6
Mode of Delivery
ARMsExperimental
DescriptiontgAAC09 (3 x 10^12 DRP) at months 0 and 12
Mode of Delivery
ARMsExperimental
DescriptionPreselected for baseline AAV neutralization titers of
Mode of Delivery
ARMsExperimental
Results: A phase 2 study to evaluate the safety and immunogenicity of a recombinant HIV type 1 vaccine based on adeno-associated virus
Official Code: NCT00888446
Trial Sponsors: IAVI
Start Date
End Date
October 31, 2005
December 31, 2007
Enrollment:91
Age range: 18 Years ↔ 50 Years
Population:Cisgender Men, Cisgender Women