Pharma giant terminates mid-stage trial following disappointing results from Phase II trial, another blow to field.
On Tuesday, J&J along with a host of global partners, announced its HIV vaccine candidate had failed to over sufficient protection against infection in young women living in sub-Saharan Africa (SSA). While the vaccine was found to be generally well tolerated, it only demonstrated 25% efficacy at preventing HIV infection in the study population over a two-year period. Titled Imbokodo study and also known as HVTN 705/HPX2008, the Phase IIb trial randomized about 2,600 young women across five sub-Saharan African countries. With a third of the 38 million people currently living with HIV worldwide found in the SSA region, the virus remains a persistent problem for the continent. In 2020, women and girls across the region accounted for over 60% of all new HIV infections.
"The high incidence of HIV among young women in sub-Saharan Africa reminds us that, despite great progress made in treatment and prevention, HIV remains a major health challenge for the region," said Professor Glenda Gray, President and CEO of the South African Medical Research Council and Imbokodo's Protocol Chair. Even with the setback, leading researchers are still hopeful lessons learned from the trial will aid the continued fight against the virus. “Although this is certainly not the study outcome for which we had hoped, we must apply the knowledge learned from the Imbokodo trial and continue our efforts to find a vaccine that will be protective against HIV” said Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, in a statement.