HVTN 105

Status:Completed
Phase:Ib
Principal Investigator(s):Michael Keefer
Objective:This study will evaluate the safety, tolerability, and immune response to different combinations of two experimental HIV vaccines—the DNA-HIV-PT123 vaccine and the AIDSVAX® B/E vaccine—in healthy adults who are not infected with HIV. Results: The DNA/protein combination regimens induced high-magnitude and long-lasting HIV V1V2–binding antibody responses, and early coadministration of the 2 vaccines led to a more rapid induction of these potentially protective responses. Last updated: October 2, 2019
Prevention Option(s):HIV Vaccine
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
DescriptionAt study entry and Month 1, participants will receive placebo for DNA-HIV-PT123 in their left deltoid and AIDSVAX B/E in their right deltoid. At Months 3 and 6, participants will receive DNA-HIV-PT123 in their left deltoid and placebo for AIDSVAX B/E in their right deltoid.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionAt study entry and Month 1, participants will receive DNA-HIV-PT123 in their left deltoid and placebo for AIDSVAX B/E in their right deltoid. At Months 3 and 6, participants will receive placebo for DNA-HIV-PT123 in their left deltoid and AIDSVAX B/E in their right deltoid.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionAt study entry and Month 1, participants will receive DNA-HIV-PT123 in their left deltoid and placebo for AIDSVAX B/E in their right deltoid. At Months 3 and 6, participants will receive DNA-HIV-PT123 in their left deltoid and AIDSVAX B/E in their right deltoid.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionAt study entry and Months 1, 3, and 6, participants will receive DNA-HIV-PT123 in their left deltoid and AIDSVAX B/E in their right deltoid.
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code: NCT02207920
Trial Sponsors: NIAID
Start Date
End Date
July 31, 2014
September 30, 2015
Enrollment:104
Age range: 18 Years ↔ 50 Years
Population:Cisgender Men, Cisgender Women