Phase Ⅲ trials will be initiated by Janssen Vaccines & Prevention, a Johnson & Johnson unit, along with the partners to evaluate an investigational preventive vaccine for HIV-1 infection.
The vaccine is mosaic-based and has been designed to target a broad range of HIV viral strains.
The study, namely Mosaico, will be launched later this year. 3,800 participants are expected to be enrolled at 55 sites in eight countries across North America, South America and Europe.
The efficacy of Janssen’s vaccine in men who have sex with men (MSM) and transgender people will be assessed in the trial. The vaccine, backed by Janssen’s AdVac adenovirus vector platform, will be administered via four vaccinations over a year.
It includes 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.
The trial will be sponsored by the company and funded by the institute of Allergy and Infectious Diseases (NIAID) and the US Army Medical Research and Development Command (USAMRDC). HIV Vaccine Trials Network (HVTN) will support its implementation.
Mosaic follows a proof-of-concept Phase Ⅱb efficacy trial called Imbokodo.
Clinical Research Newsletter
Mr Vinod Arora, Principal Advisor, IGMPI
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