HIV-V-A004/ IPCAVD-009 (APPROACH)

Status:Completed
Phase:I/II
Principal Investigator(s):
Objective:The purpose of this study (CR106152, HIV-V-A004, IPCAVD009) is to assess the safety and tolerability of various regimens containing adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV), Modified Vaccinia Ankara (MVA)-Mosaic, and/or HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) components and to compare envelope binding antibody responses between the different vaccine regimens.Result summary: The mosaic Ad26/Ad26 plus gp140 HIV-1 vaccine induced comparable and robust immune responses in humans and rhesus monkeys, and it provided significant protection against repetitive heterologous SHIV challenges in rhesus monkeys. September 14, 2022
Prevention Option(s):HIV Vaccine
Study Design:
Arms and Assigned Interventions
DescriptionParticipants will receive adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) vaccine at Week 0 and 12; followed by Ad26.Mos.HIV vaccine + HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) vaccine containing 250 microgram (mcg) of total protein mixed with adjuvant (aluminum phosphate) at Week 24 and 48.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by Ad26.Mos.HIV vaccine + gp140 DP vaccine containing 50 mcg of total protein mixed with adjuvant at Week 24 and 48.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by Ad26.Mos.HIV vaccine + placebo injection at Week 24 and 48.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by modified Vaccinia Ankara (MVA)-Mosaic vaccine + gp140 DP vaccine containing 250 mcg of total protein mixed with adjuvant at Week 24 and 48.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by MVA-Mosaic vaccine + gp140 DP vaccine containing 50 mcg of total protein mixed with adjuvant at Week 24 and 48.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by MVA-Mosaic vaccine + placebo injection at Week 24 and 48.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by gp140 DP vaccine containing 250 mcg of total protein mixed with adjuvant + placebo injection at Week 24 and 48.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive 1 placebo injection at Week 0 and 12; followed by 2 placebo injections at Week 24 and 48.
Mode of DeliveryIntramuscular
ARMsExperimental
Results: Evaluation of a mosaic HIV-1 vaccine in a multicentre, randomised, double-blind, placebo-controlled, phase 1/2a clinical trial
Official Code: NCT02315703
Trial Sponsors: Beth Israel Deaconess Medical Center, Crucell Holland BV, IAVI, NIAID, US Military HIV Research Program
Start Date
End Date
December 22, 2014
March 1, 2022
Enrollment:393
Age range: 18 Years ↔ 50 Years
Population:Cisgender Men, Cisgender Women