IAVI B003/IPCAVD 004

Status:Completed
Phase:I
Principal Investigator(s):Lindsey Baden, MD - Brigham and Women's Hospital, Boston, MA, USA *multiple investigators
Objective:The purpose of this study is to evaluate the safety and tolerability of Ad26.ENVA.01 and Ad35-ENV in low-risk for HIV-uninfected healthy adults administered in heterologous and homologous prime-boost regimens at different time intervals.
Prevention Option(s):HIV Vaccine
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
DescriptionAd26.ENVA.01 at Month 0 followed by Ad35-ENV at Month 6. Vaccine:Placebo=10:3
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionAd35-ENVA at Month 0 followed by Ad26.ENVA.01 at Month 6. Vaccine:Placebo=10:3
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionAd26.ENVA.01 at Month 0 followed by Ad35-ENV at Month 3. Vaccine:Placebo=10:3
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionAd35-ENV at Month 0 followed by Ad26.ENVA.01 at Month 3. Vaccine:Placebo=10:3
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionAd26.ENVA.01 at Month 0 followed by Ad35-ENV at Month 3. Vaccine:Placebo=16:4
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionAd35-ENV at Month 0 followed by Ad26.ENVA.01 at Month 3. Vaccine:Placebo=16:4
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionAd26.ENVA.01 at Month 0 followed by Ad26.ENVA.01 at Month 3. Vaccine:Placebo=16:4
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionAd35-ENV at Month 0 followed by Ad35-ENV at Month 3. Vaccine:Placebo=16:4
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionAd26.ENVA.01 at Month 0 followed by Ad35-ENV at Month 3. Vaccine:Placebo=16:4
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionAd35-ENV at Month 0 followed by Ad26.ENVA.01 at Month 3. Vaccine:Placebo=16:4
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionAd26.ENVA.01 at Month 0 followed by Ad26.ENVA.01 at Month 3. Vaccine:Placebo=16:4
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionAd35-ENV at Month 0 followed by Ad35-ENV at Month 3. Vaccine:Placebo=16:4
Mode of DeliveryIntramuscular
ARMsExperimental
Results: Assessment of the Safety and Immunogenicity of 2 Novel Vaccine Platforms for HIV-1 Prevention: A Randomized Trial
Official Code: NCT01215149
Trial Sponsors: Beth Israel Deaconess Medical Center, Harvard, HVTN, IAVI, MIT, MIT and Harvard, NIAID, Ragon Institute of MGH
Start Date
End Date
October 1, 2010
December 31, 2012
Enrollment:218
Age range: 18 Years ↔ 50 Years
Population:Cisgender Men, Cisgender Women