NIH to launch large-scale HIV vaccine trial in South Africa

The NIH has announced that it’ll commence a large-scale HIV vaccine trial representing “years of study and experimentation” later this year in South Africa, the first such test in 7 years.

Funded by the NIAID and conducted by the HIV Vaccine Trials Network, the Phase IIb/III trial will test the HVTN 100 vaccine regimen--made up of one experimental vaccine each supplied by Sanofi Pasteur ($SNY) and GlaxoSmithKline ($GSK)--in 5,400 HIV-uninfected men and women with 5 injections over one year.

The experimental vaccine regimen builds on work from a 2009 trial in Thailand of the vaccine RV144, which was found to be 31.2% effective 3.5 years after vaccination and 60% effective after one year. The new vaccine--currently under investigation in a smaller trial--is “designed to provide greater protection than the RV144 regimen and has been adapted to the HIV subtype that predominates in southern Africa,” according to the NIH release.

The new trial will be subject to regulatory approvals, and the team expects results in 2020.

News of the upcoming trial comes during a busy time for the active HIV vaccines field, with Duke netting $20 million in NIH funding last April to conduct its HIV vaccine research and TSRI, Johnson & Johnson and the University of Maryland all progressing with their respective candidates in the following months.

Last fall, the European Commission launched a €23 million ($25 million) collaboration among 22 organizations and companies to advance HIV vaccine research, and earlier this year, Barcelona-based Aelix Therapeutics launched in the field with a $12.7 million Series A round.

This trial, however, is an effort of the public/private HIV research initiative dubbed P5, which is made up of the NIAID, the Bill & Melinda Gates Foundation, the South African Medical Research Council, HVTN, Sanofi Pasteur, GSK and the U.S. Military HIV Research Program. The group is “committed to building on the success of the RV144 trial,” according to a statement, and is working to develop an HIV vaccine “that could have a significant public health benefit in southern Africa.”

- here’s the release

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