- The Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: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.
- Price Action: JNJ shares are down 1.30% at $170.12 on the last check Wednesday.
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