The National Institutes of Health (NIH) and partners have initiated the proof-of-concept Phase IIb Imbokodo clinical trial in sub-Saharan Africa to assess a new experimental vaccine regimen for the prevention of the HIV infection.
Based on immunogens, the vaccine regimen is being developed to trigger immune responses towards a variety of global HIV strains.
Designed to enrol 2,600 HIV-negative women, the Imbokodo trial will be conducted by NIAID-funded HIV Vaccine Trials Network (HVTN) to evaluate the safety and efficacy of the experimental regimen.
Participants will be administered with four doses of the quadrivalent mosaic vaccine at four-time points over the duration of one year, followed by two final doses in combination with clade C gp140 HIV protein and aluminium phosphate adjuvant to increase immune responses.
With a follow-up period of minimum two years, the Phase IIb trial is scheduled to report results in 2021.
The trial is being funded by Janssen Vaccines and Prevention, Bill and Melinda Gates Foundation (BMGF), and NIH’s National Institute of Allergy and Infectious Diseases (NIAID).
NIAID director Anthony Fauci said: “Together with the implementation of existing HIV prevention and treatment strategies, the development and delivery of a preventive HIV vaccine that is safe and at least moderately effective would help bring about a durable end to the HIV/AIDS pandemic.”
The NIH has also started the Phase III HPTN 084 trial in southern and eastern Africa to investigate the safety and efficacy of investigational anti-HIV injection, cabotegravir.
Set to recruit around 3,200 sexually active women aged 18-45 years in 20 centres across seven African countries, the trial will be carried out for an average of 3.6 years and results are expected in 2022.
While the trial is being sponsored by NIAID, ViiV Healthcare and the Bill and Melinda Gates Foundation, it is implemented by NIH-funded HIV Prevention Trials Network (HPTN).