Johnson & Johnson (NYSE:JNJ) today announced results from a trial of its HIV vaccine demonstrating a lack of sufficient protection against infection.
New Brunswick, N.J.–based Johnson & Johnson’s Imbokodo Phase 2b HIV vaccine clinical trial found that the investigational vaccine regimen did not provide sufficient protection against HIV infection in a 2,600-person population of young women in sub-Saharan Africa who are at high risk of acquiring HIV, although the vaccine was found to have a favorable safety profile with no serious adverse events.
The Imbokodo vaccine regimen was administered to participants through four vaccination visits over one year, with primary analysis conducted at 24 months following the first vaccination. The study found that 63 of 1,109 participants who received placebo, compared to 51 of 1,079 participants who received active vaccine, acquired HIV. The analysis demonstrated a vaccine efficacy point estimate of 25.2%.
Based on the results, the Imbokodo trial will not continue, with study participants set to be notified of the results, unblinded and informed as to whether they were in the vaccine group or placebo group within the study. Additional analysis of the Imbokodo study remains ongoing, with enough data available to progress with key immunological correlates research, J&J said in a news release.
In parallel to the Phase 2b Imbokodo HIV vaccine trial, J&J’s Janssen unit continues to sponsor the ongoing Phase 3 Mosaico study 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. That company is conducting that study in the Americas and Europe where different strains of HIV are circulating.
“We are extremely grateful to the women who volunteered for the Imbokodo study, and to our partners, including the people on the frontlines, all of whom are contributing every day to this enduring quest to make HIV history,” J&J vice chairman of the executive committee & CSO Dr. Paul Stoffels said in the release. “HIV is a unique and complex virus that has long posed unprecedented challenges for vaccine development because of its ability to attack, hijack and evade the human immune system.
“While we are disappointed that the vaccine candidate did not provide a sufficient level of protection against HIV infection in the Imbokodo trial, the study will give us important scientific findings in the ongoing pursuit for a vaccine to prevent HIV. We continue to stand in solidarity with people living with and vulnerable to HIV, and remain committed to furthering our research against this devastating virus.”
Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development, Infectious Disease