The U.S. Army Medical Research and Development Command (USAMRDC) is part of a global partnership preparing to launch Mosaico, the first large-scale Phase 3 efficacy study of an investigational mosaic-based HIV-1 preventive vaccine. This study was announced by partners last week and further details about the partnership and the study have been provided at the 10th IAS Conference on HIV Science (IAS 2019) in Mexico City.
The HIV vaccine efficacy trial aims to prevent infections by the wide range of viral strains responsible for the HIV pandemic. The trial will enroll 3,800 individuals in eight countries across North America, South America and Europe. It is expected to commence later this year.
Mosaico will be the third HIV vaccine efficacy trial in progress worldwide. The Army led the RV144 Thai trial—the first and only HIV vaccine trial to date to show efficacy. Results from RV144, an international collaboration with more than 16,000 Thai volunteers, were announced in 2009. Although the protection seen in RV144 was modest, it continues to provide scientific data and momentum for the HIV vaccine field and it helped lay the groundwork for this and other ongoing efficacy studies.
Partners in the Mosaico study include Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson; the National Institute of Allergy and Infectious Diseases (NIAID); the HIV Vaccine Trials Network (HVTN) based at the Fred Hutchinson Cancer Research Center; and the U.S. Army Medical Materiel Development Activity (USAMMDA), which is part of the U.S. Army Medical Research and Development Command (USAMRDC).
Data from the earlier Phase 2a ASCENT trial, also being presented today at IAS 2019, suggest that using a combination of mosaic gp140 and clade C gp140 proteins broadens immune responses that may enhance protection against clade B, informing the decision to use the expanded regimen in Mosaico. In the military, most HIV infections are sub-type B and with Servicemembers being deployed world-wide a vaccine that protects against all subtypes would be ideal.
The Military HIV Research Program (MHRP), another program under USAMRMC at the Walter Reed Army Institute of Research, led RV144 and played a role in early studies leading up to Mosiaco. One of the major outcomes from RV144 was that scientists were able to identify correlates of risk, providing a tool to evaluate other potential vaccines before they go into the clinic.
Globally, more than 36 million people are infected with HIV and it continues to kill nearly one million people a year, so the need for a preventive vaccine is paramount. The U.S. Army Medical Research and Development Command (USAMRDC) has been working towards the development of a safe and effective HIV vaccine to protect our Servicemembers and the global community since 1986.
For more data about Mosaico, visit ClinicalTrials.gov utilizing identifier NCT03964415.