As HIV researchers around the globe work to advance vaccines against the devastating virus, the NIAID has awarded $17.3 million to the University of Massachusetts Medical School’s Dr. Shan Lu and colleagues to develop and manufacture a prime-boost candidate for a midstage trial.
As part of a program spanning 7 years, Lu’s team will work to create a manufacturing process for the experimental vaccine intended to produce doses for several hundred volunteers in a Phase II trial, according to the school’s release. If successful, the team could seek to leverage that progress for a Phase III trial ranging in the thousands of doses.
After two decades in HIV research, Lu said in a statement the manufacturing validation program is the “next stage” for the vaccine candidate. The team has “made incredible progress in developing a cocktail of antigens capable of producing antibodies using our ‘prime-boost’ method,” he said.
The funding comes during a busy year in HIV vaccine research and on the heels of an announcement by the NIH that it’s launching a large-scale Phase IIb/III HIV vaccine trial in South Africa later this year. That study will test HVTN 100--made up of one experimental vaccine each supplied by Sanofi Pasteur and GlaxoSmithKline ($GSK)--in 5,400 HIV-uninfected men and women with 5 injections over one year.
Aside from the NIH, players large and small have committed to the effort over the past year; Aelix Therapeutics launched with $12.7 million in January and the European Commission before that committed €23 million to a public-private partnership of 22 institutions.
For their approach, Lu and colleagues joined an in-house DNA vaccine with a recombinant protein-based vaccine. They’re expecting to further revamp the shot, according to a statement, and will work with clinical supply manufacturer Waisman Biomanufacturing on the next steps.
- here’s the release
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