In a major step forward for HIV vaccine research, the U.S. research agency will partner with a pharmaceutical company on a large-scale, advanced-stage clinical study on an HIV vaccine. If the trial is successful, the vaccine may become the first ever to be approved for HIV prevention. But the rise of PrEP has created unexpected challenges to study enrollment.
The study, called Mosaico, will recruit 3,800 cisgender men and transgender people who have sex with men and/or transgender people in the United States, Latin America, and Europe. It is being conducted in collaboration with the HIV Vaccine Trials Network. It is being sponsored by Janssen Pharmaceuticals (the medical research arm of Johnson & Johnson) and the National Institutes of Health (NIH), and conducted in collaboration with the HIV Vaccine Trials Network.
Specifically, the Phase 3, randomized study will recruit from 55 sites in mostly urban locations in the United States, Mexico, Peru, Brazil, Argentina, Poland, Spain, and Italy. Enrollment in the trial will begin in 2020.
In the trial, the vaccine candidate will be given as an injection to people who are HIV negative at four different time points over 12 months. Critically, study sponsors say that patients who volunteer for the trial will be counselled on other HIV prevention options, including pre-exposure prophylaxis (PrEP).
“I think it’s an interesting step in the right direction,” said Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID) at NIH. However, he cautioned, “I generally don’t get excited about things until I see the data.”
“We still have a number of years to go,” said Mitchell Warren, executive director of AVAC: Global Advocacy for HIV Prevention. “But for a field that has struggled for many, many years — this vaccine matters.”
Although scientists have been hunting for an HIV vaccine for the past three decades, their quest has remained elusive — in part because the virus has evolved into multiple different strains that are clustered in different regions across the globe.
Source: This article was written by Aaron Anderson for www.thebodypro.com