Johnson & Johnson's HIV Vaccine Regimen Does Not Prevent Infection, Phase 3 Study Shows

The Janssen Pharmaceutical Companies of Johnson & Johnson JNJ announced the results of an independent, scheduled data review of the Phase 3 Mosaico study of the 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 the placebo among study participants.
No safety issues with the vaccine regimen were identified.
The Mosaico clinical trial will be discontinued in light of the DSMB’s determination. Further data analyses are underway.
Throughout the trial, study investigators ensured that any individuals who contracted HIV received prompt treatment.
The study began in 2019 and included approximately 3,900 cisgender men and transgender people who have sex with cisgender men and/or transgender people.
The study evaluated an investigational vaccine regimen containing a mosaic-based adenovirus serotype 26 vector (Ad26.Mos4.HIV) administered during four vaccination visits over one year.
The DSMB’s determination follows the primary analysis of Phase 2b Imbokodo study, which was announced in August 2021 and found that a similar investigational HIV vaccine regimen did not provide sufficient protection against HIV in young women in sub-Saharan Africa.
The investigational vaccine regimen used in the Imbokodo study was found to have a favorable safety profile.
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