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Another HIV Vaccine Regimen Lacks Efficacy in Prevention

January 19, 2023 • 10:35 am CST
by Gerd Altmann
(Precision Vaccinations)

The Janssen Pharmaceutical Companies of Johnson & Johnson and a consortium of global partners announced the results of an independent, scheduled data review of the Phase 3 Mosaico study of Janssen's investigational HIV vaccine regimen.

The study's independent Data and Safety Monitoring Board (DSMB) determined that the regimen was ineffective in preventing HIV infection compared to placebo.

In light of the DSMB's determination, the Mosaico clinical trial was discontinued.

Mosaico 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 U.S.

"We are disappointed with this outcome and stand in solidarity with the people and communities vulnerable to and affected by HIV," said Penny Heaton, M.D., Global Therapeutic Area Head, Vaccines, Janssen Research & Development, LLC., in a press release on January 18, 2023.

"We remain steadfast in our commitment to advancing innovation in HIV, and we hope the data from Mosaico will provide insights for future efforts to develop a safe and effective vaccine."

The Mosaico findings align with developments in the Phase 2b “Imbokodo” clinical trial, which tested a similar HIV vaccine regimen in women in sub-Saharan Africa. 

That DSMB determined in August 2021 that the experimental vaccine regimen was also ineffective in protecting against HIV acquisition.

As of January 19, 2023, the U.S. Food and Drug Administration had not approved an HIV vaccine candidate.