HVTN 705 / HPX2008 / CR108263/ Imbokodo

Status:Completed
Phase:IIb
Principal Investigator(s):
Objective:The primary purpose of this study is to assess the preventive vaccine efficacy (VE), safety and tolerability of a heterologous prime/boost regimen utilizing Ad26.Mos4.HIV and aluminum-phosphate adjuvanted Clade C gp140 for the prevention of Human Immuno Virus (HIV) infection in HIV-seronegative women residing in sub-Saharan Africa from confirmed HIV-1 infections diagnosed between the Month 7 and Month 24 visits. The primary purpose of this study is to assess the preventive vaccine efficacy (VE), safety and tolerability of a heterologous prime/boost regimen utilizing Ad26.Mos4.HIV and aluminum-phosphate adjuvanted Clade C gp140 for the prevention of Human Immuno Virus (HIV) infection in HIV-seronegative women residing in sub-Saharan Africa from confirmed HIV-1 infections diagnosed between the Month 7 and Month 24 visits. The primary purpose of this study is to assess the preventive vaccine efficacy (VE), safety and tolerability of a heterologous prime/boost regimen utilizing Ad26.Mos4.HIV and aluminum-phosphate adjuvanted Clade C gp 140 for the prevention of Human Immuno Virus (HIV) infection in HIV-seronegative women residing in sub-Saharan Africa from confirmed HIV-1 infections diagnosed between the Month 7 and Month 24 visits.Result: An investigational HIV vaccine tested in the “Imbokodo” clinical trial conducted in sub-Saharan Africa posed no safety concerns but did not provide sufficient protection against HIV infection, according to a primary analysis of the study data (NIH, 2021). The vaccine may have shown superior protection in participants aged 31-35, but the numbers are too small to draw firm conclusions (TAG Pipeline Report, 2022). Last updated September 13, 2022.
Prevention Option(s):HIV Vaccine
Study Design:Double-blind, Placebo-controlled, Randomized
Arms and Assigned Interventions
DescriptionParticipants will receive Ad26.Mos4.HIV 5*10^10 virus particles (vp) as 0.5 milliliter (mL) via Intramuscular (IM) injection into the left deltoid on Months 0, 3, 6, and 12 and Clade C gp140 (250 [microgram] mcg) co-formulated with Aluminum phosphate adjuvant as 0.5 mL IM into the right deltoid on Months 6 and 12.
Mode of DeliveryIntramuscular
ARMsExperimental
Results: Johnson & Johnson and Global Partners Announce Results from Phase 2b Imbokodo HIV Vaccine Clinical Trial in Young Women in Sub-Saharan Africa
Official Code: NCT03060629
Related Publications:
Evaluation of a mosaic HIV-1 vaccine in a multicentre, randomised, double-blind, placebo-controlled, phase 1/2a clinical trial (APPROACH) and in rhesus monkeys (NHP 13-19)
IAVI statement on results from Phase IIb Imbokodo HIV vaccine clinical trial
HIV Vaccine Candidate Does Not Sufficiently Protect Women Against HIV Infection
Trial Sponsors: HVTN, Janssen Vaccines & Prevention B.V., NIAID, Ragon Institute, SAMRC, US Army Medical Research and Development Command
Start Date
End Date
November 3, 2017
July 23, 2022
Enrollment:2,637
Age range: 18 Years ↔ 35 Years
Population:Cisgender Women