'Mosaic' HIV vaccine from J&J and partners passes early test

The decadeslong quest for a successful HIV vaccine has yielded plenty of failures, but with new early-stage results announced Monday, Johnson & Johnson and its partners hope they might have a winner.

J&J touted the phase 1/2a study results early Monday, announcing that an investigational shot appeared to be well-tolerated and elicited HIV-1 antibody responses in all participants. The study tested a “mosaic” HIV vaccine in nearly 400 patients across the U.S, Rwanda, Uganda, South Africa and Thailand.

Speaking with FiercePharma ahead of the data release, lead investigator Dan Barouch said the vaccine is designed using computer sequencing to protect against HIV subtypes all over the world. Other HIV vaccine programs have aimed at protecting against the virus in different global regions, he said, limiting how they would be deployed.

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While the results are early, Barouch said the immune responses seen in study participants are similar to those that scientists showed to be protective against HIV in animal studies. Barouch serves as director of the Center for Virology at Harvard’s Beth Israel Deaconess Medical Center.

J&J is working on the program in conjunction with the Beth Israel, Walter Reed Army Institute of Research, the National Institute of Allergy and Infectious Diseases and other groups. In its announcement, the pharma giant said further testing could start in southern African countries late this year or early next year.

“We are really convinced that a vaccine will be the holy grail to solve the problem of the HIV epidemic,” Janssen head of viral vaccines discovery and translational medicine Hanneke Schuitemaker told FiercePharma.

If testing progresses to phase 2b as the partners hope, it will be only the fifth HIV vaccine candidate to move into efficacy testing in 35 years, according to Barouch. The team can’t predict how the shot will fare in the future, but he said they’re “optimistic” it will outperform past shots based on the promise it’s shown to date.

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“We need more shots on goal for a disease of this global impact and global burden,” Barouch said. “We need to be testing more HIV vaccines, and of course we need to find one that actually works.”

The results come several months after the National Institutes of Health and its partners launched a phase 2b/3 test for their investigational vaccine in South Africa. That group is using vaccine components from GlaxoSmithKline and Sanofi, testing the regimen in 5,400 sexually active men and women aged 18 to 35 who don’t have the infection. Participants will receive five injections over a year, and results are expected in 2020.

Other groups working on their own HIV vaccines include a public-private collaboration in Europe, the University of MassachusettsUniversity of MarylandTexas BiomedDuke University, GeoVax and startup Aelix.