HIV Vaccine Fails in Phase 3 Trial

The Janssen Pharmaceutical Companies of Johnson & Johnson, together with a consortium of global partners, have announced discontinuation of its HIV vaccine Phase 3 clinical trial based on the results of an independent data review by the study’s independent Data and Safety Monitoring Board (DSMB). The review determined that the HIV vaccine regimen was not effective in preventing HIV infection compared to placebo among study participants. No safety issues with the vaccine regimen were identified. Participant notifications and further analyses of the data are underway, according to the company.

“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. “Though there have been significant advances in prevention since the beginning of the global epidemic, 1.5 million people acquired HIV in 2021 alone, underscoring the high unmet need for new options and why we have long worked to tackle this global health challenge. We remain steadfast in our commitment to advancing innovation in HIV, and we hope the data from the trial will provide insights for future efforts to develop a safe and effective vaccine.”  (Source: Janssen Pharmaceuticals Website, 18 January, 2023)