Johnson & Johnson to initiate late-stage study of investigational tetravalent HIV vaccine this year

Johnson & Johnson on Friday confirmed that it was launching a Phase III study of an experimental heterologous vaccine regimen in the US and Europe later this year. Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, which will collaborate on the effort, said the MOSAICO trial will include about 3800 men who engage in sex with other men, with study results expected as soon as 2023. 

Paul Stoffels, chief scientific officer at Johnson & Johnson, stated "the cost of treating HIV patients -- the burden for patients, the burden for society -- is very high," adding that HIV prevention remains "a big mission for us. We've been working on it for almost 30 years."

Harvard Medical School professor Dan Barouch, whose research supported development of the vaccine, explained that it contains four components that target multiple strains of HIV. The approach "brings us one step closer to covering the vast diversity of viruses worldwide," he said. In the study, participants will receive six doses over four sessions. Specifically, the regimen consists of tetravalent vaccine Ad26.Mos4.HIV, along with aluminum phosphate-adjuvanted Clade C gp140 and Mosaic gp140, for the prevention of HIV-1 infection. 

A different version of the mosaic vaccine is currently in Phase II testing in Africa in the Imbokodo study that started in 2017 and enrolled about 2600 women in five countries. Mitchell Warren, executive director of the HIV prevention advocacy group AVAC, suggested that conducting the MOSAICO and Imbokodo studies in parallel could shorten the time needed to win regulatory approval. Meanwhile, Hanneke Schuitemaker, head of viral vaccine discovery and translational medicine at Johnson & Johnson's Janssen unit, suggested that even if MOSAICO fails, the company would probably continue with the second trial, given the differences between the two study populations.

Johnson & Johnson gained rights to the experimental vaccine as part of its purchase of Crucell in 2010 for €1.75 billion ($2 billion). 

In April, ViiV Healthcare announced a filing seeking US approval of a monthly injectable HIV treatment combining Johnson & Johnson's non-nucleoside reverse transcriptase inhibitor Edurant (rilpivirine) and the experimental integrase inhibitor cabotegravir for use in certain adults with HIV-1 infection.  

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