Johnson & Johnson's Janssen is calling it quits on phase 3 trial of its investigational HIV vaccine after a data review revealed that the regimen was not effective in preventing HIV infection.
The Mosaico study of Janssen’s investigational HIV vaccine regimen began in 2019, and completed vaccinations in October 2022. The study included approximately 3,900 cisgender men and transgender people who have sex with cisgender men and/or transgender people, who represent groups and populations vulnerable to HIV, at over 50 trial sites in Argentina, Brazil, Italy, Mexico, Peru, Poland, Puerto Rico, Spain and the United States.
In light of the independent Data and Safety Monitoring Board's determination, the trial — which evaluated a vaccine regimen containing a mosaic-based adenovirus serotype 26 vector (Ad26.Mos4.HIV) administered during four vaccination visits over one year — will now be discontinued.
The Mosaico study was led by a global public-private partnership which included the National Institute of Allergy and Infectious Diseases , the National Institutes of Health and the HIV Vaccine Trials Network.
The disappointing news follows a similar analysis — announced in August 2021— of Janssen's phase 2b Imbokodo study, which found that a similar investigational HIV vaccine regimen did not provide sufficient protection against HIV in a population of young women in sub-Saharan Africa.
