July 15 (UPI) -- The National Institutes of Health announced plans to begin a phase of trials on Monday on a new HIV vaccine.
The agency's National Institute of Allergy and Infectious Diseases, a division of the U.S. Department of Health and Human Services, will start Phase 3 HIV vaccine efficacy trials to assess if a vaccine regimen can safely and effectively prevent HIV acquisition among men who have sex with men and transgender people.
The trial, called HPX3002/HVTN 706, or "Mosaico," will be conducted among 3,800 men at clinical research sites in the United States, Argentina, Brazil, Italy, Mexico, Peru, Poland and Spain.
A complementary study in women called HPX2008/HVTN 705, or "Imbokodo" was begun in 2017 in five southern African countries.
"We are committed to developing a safe and effective preventive HIV vaccine suitable for the global populations most vulnerable to HIV acquisition," said Anthony S. Fauci, M.D., director of the NIAID. "Ensuring that investigational vaccines are evaluated in diverse populations is critical to achieving this goal."
In Europe and the Americas, men who have sex with men and transgender people are disproportionately affected by HIV, and in the United States, gay and bisexual men account for two-thirds of new HIV diagnoses, a NIH paper said. In eastern and southern Africa, women and girls account for nearly 60 percent of people with HIV.
The two studies, on men and on women, evaluate vaccines based on "mosaic" immunogens, with components from multiple HIV subtypes. Different HIV subtypes, or clades, predominate in various geographic regions around the world. Clade C HIV is common in southern Africa, while clade B is predominant in the regions of Europe and the Americas where Mosaico will enroll participants.
The public-private Mosaico study is sponsored by Janssen Vaccines & Prevention, B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, with funding support from the NIAID. The HIV Vaccine Trials Network at the Fred Hutchinson Cancer Research Center in Seattle is facilitating the implementation of the study. The U.S. Army Medical Research and Development Command is also providing support.