HVTN 090

Status:Completed
Phase:I
Principal Investigator(s):Jonathan Fuchs, San Francisco Department of Public Health/University of California, San Francisco
Objective:The purpose of this study is to evaluate the safety and immune response to an HIV vaccine in HIV-uninfected adults. Study researchers will also determine the maximum dose of the vaccine that participants can safely receive.   last updated March 30, 2021
Prevention Option(s):HIV Vaccine
Study Design:Blind, Controlled, Randomized
Arms and Assigned Interventions
DescriptionGroup 1: Participants will receive 1 x 10^4 PFU of the study vaccine by intramuscular (IM) injection in each deltoid at baseline and Week 8. (1 x 10^4 PFU is the nominal dose; the actual dose is 4.6 x 10^3 PFU given as 2.3 x 10^3 PFU in each deltoid)
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionGroup 2: Participants will receive 1 x 10^5 PFU of the study vaccine by IM injection in each deltoid at baseline and Week 8. (1 x 10^5 PFU is the nominal dose; the actual dose is 4.6 x 10^4 PFU given as 2.3 x 10^4 PFU in each deltoid)
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionGroup 3: Participants will receive 1 x 10^6 PFU of the study vaccine by IM injection in each deltoid at baseline and Week 8. (1 x 10^6 PFU is the nominal dose; the actual dose is 4.8 x 10^5 PFU given as 2.4 x 10^5 PFU in each deltoid)
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionGroup 4: Participants will receive 1 x 10^7 PFU of the study vaccine by IM injection in each deltoid at baseline and Week 8. (1 x 10^7 PFU is the nominal dose; the actual dose is 4.2 x 10^6 PFU given as 2.1 x 10^6 PFU in each deltoid)
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionGroup 5: Participants will receive 1 x 10^8 PFU of the study vaccine by IM injection in each deltoid at baseline and Week 8. (1 x 10^8 PFU is the nominal dose; the actual dose is 3.4 x 10^7 PFU given as 1.7 x 10^7 PFU in each deltoid)
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code: NCT01438606
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Trial Sponsors: NIAID
Start Date
End Date
October 1, 2011
January 31, 2013
Enrollment:60
Age range: 18 Years ↔ 50 Years
Population: