NIH, others launch 'historic' HIV trial with vaccines from GSK, Sanofi

Seeking to deliver the “final nail in the coffin for HIV,” NIH scientists have kicked off a large clinical trial of a vaccine regimen this week in South Africa.

Under a collaboration that includes GlaxoSmithKline and Sanofi Pasteur, the National Institute of Allergy and Infectious Diseases started a phase 2b/3 trial of a new vaccine regimen in 5,400 sexually active men and women aged 18 to 35 who don’t have the infection. They’ll receive five injections over a year.

The 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.

If it’s found to be effective, the vaccine, plus current tools against the virus, “could be the final nail in the coffin for HIV,” NIAID director Anthony Fauci said in a statement about the new trial.

“Even a moderately effective vaccine would significantly decrease the burden of HIV disease over time in countries and populations with high rates of HIV infection, such as South Africa,” Fauci said.

HVTN 702 represents the first efficacy study for a HIV vaccine in 7 years, with experts hoping to build on progress made in the RV144 trial in Thailand. Back in 2009, results from that test showed the shot was 31.2% effective at preventing HIV infection during a 3.5 year follow-up period.

Now, the groups will test a vaccine they hope can “provide greater and more sustained protection” against HIV. It’s been modified to better fight the virus in the region around South Africa.

The HIV Vaccine Trials Network will conduct the test at 15 sites in the country. Other groups involved are the Bill & Melinda Gates Foundation, the South African Medical Research Council and the U.S. Military HIV Research Program.

Outside of the NIH-supported trial, which will test a more advanced regimen, HIV vaccine research at earlier stages continues to remain a focus for teams around the world. Last week, a group from Australia reported that their candidate might be able to provide frontline protection against the virus. Before that, The Scripps Research Institute this month signed on to test Yisheng Biopharma’s adjuvant in conjunction with its own HIV vax technology.

Other players in the space include the University of Massachusetts, University of Maryland, Texas Biomed, Duke University, Johnson & Johnson and startup Aelix. In Europe, authorities established a 23 million Euro ($25 million) collaboration last year that involved 22 companies and organizations working on a vaccine.