RV 262
Status:Completed
Phase:I
Principal Investigator(s):MAJ Julie Ake, MD
Objective:The purpose of this study is to evaluate the safety of and immune response to an HIV vaccine, administered using two different devices, followed by a vaccine boost, in healthy, HIV-uninfected adults.last updated March 30, 2021
Prevention Option(s):HIV Vaccine
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
DescriptionParticipants will receive PENNVAX-G vaccine administered by intramuscular injection (IM) via Biojector 2000 needleless device in either deltoid on Days 0 and 28. They will then receive MVA-CMDR administered IM by needle and syringe in either deltoid on Days 84 and 168.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive PENNVAX-G vaccine administered via CELLECTRA EP in either deltoid on Days 0 and 28. They will then receive MVA-CMDR administered IM by needle and syringe in either deltoid on Days 84 and 168.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive PENNVAX-G vaccine administered IM via Biojector 2000 needleless device in either deltoid on Days 0 and 28. They will then receive MVA-CMDR administered IM by needle and syringe in either deltoid on Days 84 and 168.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive PENNVAX-G vaccine administered IM via CELLECTRA EP in either deltoid on Days 0 and 28. They will then receive MVA-CMDR administered IM by needle and syringe in either deltoid on Days 84 and 168.
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code:
NCT01260727
Trial Sponsors:
NIAID
Start Date
End Date
February 28, 2010
June 30, 2015
Enrollment:92
Age range:
18 Years ↔
49 Years
Population:Cisgender Men, Cisgender Women