HVTN 101

Status:Withdrawn
Phase:I
Principal Investigator(s):Magdalena Sobieszczyk
Objective:The purpose of this study is to evaluate the safety and immune response to two different HIV vaccine regimens in healthy, HIV-uninfected people in the United States and South Africa.
Prevention Option(s):HIV Vaccine
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionParticipants will receive the DNA-HIV-PT123 vaccine administered as 1 mL intramuscularly (IM) and placebo (sodium chloride for injection, 0.9%) administered as 1 mL each in the left deltoid at Months 0 and 1. They will then receive the NYVAC-HIV-PT1 vaccine and the NYVAC-HIV-PT4 vaccine; each will be administered as 1 mL IM in the left deltoid and the AIDSVAX B/E vaccine administered as 1 mL IM in the right deltoid at Months 3 and 6.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive the DNA-HIV-PT123 vaccine administered as 1 mL intramuscularly (IM) and placebo (sodium chloride for injection, 0.9%) administered as 1 mL each in the left deltoid at Months 0 and 1. They will then receive the NYVAC-HIV-PT1 vaccine and the NYVAC-HIV-PT4 vaccine; each will be administered as 1 mL IM in the left deltoid and the AIDSVAX B/E vaccine administered as 1 mL IM in the right deltoid at Months 3 and 6.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive the NYVAC-HIV-PT1 vaccine and the NYVAC-HIV-PT4 vaccine, each administered as 1 mL IM in the left deltoid at Months 0 and 1. They will then receive the NYVAC-HIV-PT1 vaccine and the NYVAC-HIV-PT4 vaccine; each will be administered as 1 mL IM in the left deltoid, and the AIDSVAX B/E vaccine administered as 1 mL IM in the right deltoid at Months 3 and 6.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive the NYVAC-HIV-PT1 vaccine and the NYVAC-HIV-PT4 vaccine, each administered as 1 mL IM in the left deltoid at Months 0 and 1. They will then receive the NYVAC-HIV-PT1 vaccine and the NYVAC-HIV-PT4 vaccine; each will be administered as 1 mL IM in the left deltoid, and the AIDSVAX B/E vaccine administered as 1 mL IM in the right deltoid at Months 3 and 6.
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code: NCT01927835
Start Date
End Date
none
January 1, 2017
Enrollment:264
Age range: 18 Years ↔ 50 Years
Population:Cisgender Men, Cisgender Women