– Johnson & Johnson (NYSE: JNJ), together with a consortium of global partners, today announced results from the primary analysis of a Phase 2b HIV vaccine clinical trial known as the Imbokodo study (also known as HVTN 705 HPX2008). Data showed the investigational HIV vaccine regimen did not provide sufficient protection against HIV infection in a population of young women in sub-Saharan Africa at high risk of acquiring HIV. The investigational vaccine was found to have a favorable safety profile with no serious adverse events.
Based on these results, the Imbokodo study will not continue. Study participants will be notified of the results, unblinded and informed whether they were in the study group who received the vaccine or the group who received placebo. Further analysis of the Imbokodo study is ongoing, and the study has provided enough data to progress with key immunological correlates research.
In parallel to the Phase 2b Imbokodo HIV vaccine trial, Janssen is sponsoring the ongoing Phase 3 Mosaico study (HVTN 706/HPX3002) which is testing the safety and efficacy of a different composition of the HIV vaccine regimen among men who have sex with men (MSM) and transgender individuals. This study is being conducted in the Americas and Europe where different strains of HIV are circulating. Given these differentiating factors and following consultations with the Mosaico study independent Data and Safety Monitoring Board (DSMB), it was decided that the Mosaico...
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