Right on the heels of the world's first large-scale HIV vaccine trial in several years, Johnson & Johnson and partners on Thursday pushed their promising "mosaic" vaccine candidate into efficacy testing.
Dubbed Imbokodo, the phase 2b study will test the J&J regimen in 2,600 sexually active women between the ages of 18 and 35 in five southern African countries. Women and girls account for nearly 60% of people living with HIV in eastern and southern Africa. It's only the fifth vaccine to reach efficacy testing in 35 years, an expert involved in the program previously told FiercePharma.
As the vaccine has already turned in promising data on immune responses and safety, the team now wants to see if it can reduce infections against placebo. Vaccinations have already started in South Africa, according to the group, and investigators are also looking to expand the study to include participants in Malawi, Mozambique, Zambia and Zimbabwe.
Ahead of a phase 1/2a data release for the program this summer, Dan Barouch, lead investigator for that trial, said the vaccine is designed with computer sequencing to protect against HIV subtypes all over the world. Other HIV vaccines are aimed at protecting against the virus in different regions, he said, limiting how they would be deployed.
The J&J team hopes the shot can serve as a "global vaccine" to address the problem worldwide. The pharma giant is sponsoring the trial, with other funding coming from the Bill & Melinda Gates Foundation and the National Institute for Allergy and Infectious Diseases, plus several other collaborators.
On Thursday, Janssen head of viral vaccines discovery and translational medicine Hanneke Schuitemaker told FiercePharma the regimen incorporates 4 doses over 48 weeks. For this study, the team is testing the vaccine exclusively in women because HIV incidence is higher in women in the region. Additionally, she said, women are more reliable for follow-ups over the duration.
But in order to develop a true "global vaccine," J&J would have to conduct other efficacy tests around the world, according to Schuitemaker. She said Imbokodo will give the team a valuable "first look" at efficacy.
Noting that previous HIV vaccine efficacy trials have turned in less-than-desirable results, Barouch told FiercePharma this summer the scientific community needs "more shots on goal for a disease of this global impact and global burden." Barouch is the director of the Center for Virology at Harvard’s Beth Israel Deaconess Medical Center.
To that end, the National Institutes of Health and partners separately launched a large phase 2b/3 test this year for another investigational vaccine in South Africa. That candidate is made up of one experimental vaccine each supplied by Sanofi Pasteur and GlaxoSmithKline, combined with a GSK-supplied adjuvant called MF59. Results from the trial are expected in 2020. An earlier trial in Thailand showed that the regimen was 31.2% effective during a 3.5 year follow-up period, and the collaborators are hoping to improve on those results.
When that study started, it was the world's first HIV vaccine efficacy trial in 7 years, according to the group. With J&J's new trial, there are two ongoing HIV vaccine efficacy studies for the first time in a decade.