Janssen Vaccines & Prevention, a Johnson & Johnson unit, along with a consortium of partners is set to initiate a Phase III clinical trial to evaluate an investigational preventive vaccine for HIV-1 infection.
The mosaic-based vaccine has been designed to target a broad range of HIV viral strains.
Named Mosaico, the study will be launched later this year. It expects to enrol 3,800 participants at 55 sites in eight countries across North America, South America and Europe.
The trial will assess the efficacy of Janssen’s vaccine in men who have sex with men (MSM) and transgender people.
The investigational vaccine, backed by Janssen’s AdVac adenovirus vector platform, will be administered via four vaccinations over a year.
It consists of four adenovirus serotype 26 vectors that deliver mosaic HIV antigens, Ad26.Mos4.HIV, and a combination of Mosaic and Clade C trimeric gp140 proteins adjuvanted using aluminium phosphate.
Janssen Vaccines & Prevention will sponsor the trial. The National Institute of Allergy and Infectious Diseases (NIAID) and the US Army Medical Research and Development Command (USAMRDC) will provide funding support.
The HIV Vaccine Trials Network (HVTN) will support the implementation of the trial.
Johnson & Johnson chief scientific officer and executive committee vice-chairman Paul Stoffels said: “Our vision at Johnson & Johnson is to develop a preventive vaccine that can be deployed anywhere, worldwide, to halt the HIV epidemic.
“No single organisation can tackle this historic challenge alone. By working with our global partners and leveraging cutting-edge technologies, we are optimistic that we can achieve an HIV vaccine in our lifetime.”
Mosaico follows a proof-of-concept Phase IIb efficacy trial called Imbokodo that is investigating a mosaic-based vaccine regimen in 2,600 women aged 18-35 years in five southern African countries.
Initial data from Imbokodo and Mosaico are anticipated to be reported in 2021 and 2023, respectively.