IAVI A003

Status:Completed
Phase:I
Principal Investigator(s):David JM Lewis
Objective:The purpose of this study is to evaluate the safety, tolerability and immunogenicity of rAAV1-PG9DP at different doses in healthy male adults.
Prevention Option(s):HIV Vaccine
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
DescriptionrAAV1-PG9DP or placebo (v:p = 3:1) rAAV1-PG9DP 4x10^12 vg
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionrAAV1-PG9DP or placebo (v:p = 3:1) rAAV1-PG9DP 4x10^13 vg
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionrAAV1-PG9DP or placebo (v:p = 3:1 in Group C, and v:p = 9:3 in Group C1) rAAV1-PG9DP 8x10^13 vg
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionrAAV1-PG9DP or placebo (v:p = 3:1 in Group D and D1) rAAV1-PG9DP 1.2x10^14 vg
Mode of DeliveryIntramuscular
ARMsExperimental
Results: Adeno-associated virus vectored immunoprophylaxis to prevent HIV in healthy adults: a phase 1 randomised controlled trial.
Official Code: NCT01937455
Related Publications:
Delivery of anti-HIV bNAbs by viral vectors
Trial Sponsors: Children's Hospital of Philadelphia, IAVI, NIAID
Start Date
End Date
September 30, 2014
February 8, 2018
Enrollment:21
Age range: 18 Years ↔ 45 Years
Population:Cisgender Men