A historic trial to test safety and efficacy of an experimental HIV vaccine is under way at 15 sites in South Africa, where more than 1,000 people become infected with HIV every day, says the NIH.
The Phase2b/3 study, HVTN 702, is the first HIV vaccine efficacy study in 8 years. The regimen involves a new version of the only HIV vaccine candidate ever shown to provide some protection against the virus. That vaccine, tested in the 2009 RV144 clinical trial in Thailand, led by the U.S. military HIV Research program and the Thai Ministry of Health, delivered “landmark results.”
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RV144 found for the first time that a vaccine could prevent HIV infection, “albeit modestly.” The vaccine was 31.2% effective at preventing infection over the nearly 4-year follow-up. HVTN 702, researchers hope, will provide more sustained protection; the components of the RV144 regimen have been modified to try to increase the magnitude and duration of immune responses. Recently, interim results were reported for HVTN 100, the predecessor clinical trial, which found the new vaccine regimen was safe for the 252 study participants and induced immune responses comparable with those in RV144.
Researchers aim to enroll 5,400 men and women in HVTN 702, which will make it the largest and most advanced HIV vaccine clinical trial to take place in South Africa. “If an HIV vaccine were found to work in South Africa, it could dramatically alter the course of the pandemic,” said HVTN 702 Protocol Chair Glenda Gray, MBBCH, FC Paed (SA).
“[A] safe and effective vaccine could be the final nail in the coffin for HIV,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, a cofunder of the study. Results from HVTN 702 are expected in 2020.
Source:
First new HIV vaccine efficacy study in seven years has begun [news release]. National Institute of Allergy and Infectious Disease; November 27, 2016. https://www.niaid.nih.gov/news-events/first-new-hiv-vaccine-efficacy-study-seven-years-has-begun. Accessed August 23, 2017.