The National Institutes of Health and partners today announced plans to conduct a Phase 3 HIV vaccine efficacy trial at multiple clinical research sites in North America, South America and Europe. The trial, called HPX3002/HVTN 706 or Mosaico, will assess whether an investigational vaccine regimen designed to induce immune responses against a variety of global HIV strains can safely and effectively prevent HIV acquisition among men who have sex with men and transgender people. A complementary study in women called HPX2008/HVTN 705 or Imbokodo that launched in 2017 in five southern African countries is ongoing.
Mosaico is sponsored by Janssen Vaccines & Prevention, B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, with funding support from NIH’s National Institute of Allergy and Infectious Diseases (NIAID). The HIV Vaccine Trials Network (HVTN), headquartered at the Fred Hutchinson Cancer Research Center in Seattle, is facilitating the implementation of the study. Additional partners providing support include the U.S. Army Medical Research and Development Command (USAMRDC). The public-private partnership’s plans for Mosaico will be described in more detail at the 10th IAS Conference on HIV Science (IAS 2019) in Mexico City.
This Phase 3 efficacy study will enroll 3,800 HIV-negative men and transgender people aged 18 to 60 years who have sex with men and/or transgender people. It is anticipated to open for enrollment at clinical research sites in the United States later this year. In addition, clinical research sites in Argentina, Brazil, Italy, Mexico, Peru, Poland and Spain will participate in the study.
“We are committed to developing a safe and effective preventive HIV vaccine suitable for the global populations most vulnerable to HIV acquisition,” said NIAID Director Anthony S. Fauci, M.D. “Ensuring that investigational vaccines are evaluated in diverse populations is critical to achieving this goal.”