HVTN 096

Status:Completed
Phase:I
Principal Investigator(s):Giuseppe Pantaleo, MD
Objective:This study will evaluate the safety of and the body's immune response to experimental HIV vaccine regimens using different vaccine priming combination, and boosting with the vaccines NYVAC and AIDSVAX® B/E.   last updated March 30, 2021
Prevention Option(s):HIV Vaccine
Study Design:Placebo, Randomized
Arms and Assigned Interventions
DescriptionNYVAC Prime / NYVAC + AIDSVAX® B/E Boost vs. Placebo: This arm will evaluate the safety of and the body's immune response to a vaccine regimen consisting of a NYVAC vaccine prime and NYVAC + AIDSVAX® B/E boost. Twenty participants will get vaccines and 4 will get only placebos.
Mode of Delivery
ARMsExperimental
DescriptionNYVAC + AIDSVAX® B/E Prime / Boost vs. placebo: This arm will evaluate the safety of and the body's immune response to a vaccine regimen consisting of priming and boosting with the vaccines NYVAC + AIDSVAX® B/E. Twenty participants will receive the vaccines and 4 will receive placebos. This arm will also be compared to arm 1 to see if the priming makes a difference in the body's immune response.
Mode of Delivery
ARMsExperimental
DescriptionDNA prime + NYVAC + AIDSVAX® B/E Boost vs. placebo: This arm will evaluate the safety of and the body's immune response to a vaccine regimen consisting of a DNA vaccine priming and NYVAC + AIDSVAX® B/E boosting. Twenty participants will receive the vaccines and 4 will receive placebos. This arm will also be compared to arm 4 to see if the priming makes a difference in the body's immune response.
Mode of Delivery
ARMsExperimental
DescriptionDNA+AIDSVAX® B/E prime / NYVAC+AIDSVAX® B/E boost vs. placebo This arm will evaluate the safety of and the body's immune response to a vaccine regimen consisting of a DNA vaccine + AIDSVAX® B/E priming and NYVAC + AIDSVAX® B/E boosting. Twenty participants will receive the vaccines and 4 will receive placebos. This arm will also be compared to arm 3 to see if the priming makes a difference in the body's immune response.
Mode of Delivery
ARMsExperimental
Results: Safety and immunogenicity of a multivalent HIV vaccine comprising envelope protein with either DNA or NYVAC vectors
Official Code: NCT01799954
Related Publications:
Predictors of durable immune responses six months after the last vaccination in preventive HIV vaccine trials
Trial Sponsors: HVTN
Start Date
End Date
August 31, 2012
December 4, 2014
Enrollment:96
Age range: 18 Years ↔ 50 Years
Population:Cisgender Men, Cisgender Women