A phase I clinical trial to investigate three messenger RNA (mRNA) platform-based HIV vaccines is underway in the United States. The trial, HVTN 302, is being conducted by the National Institute of Allergy and Infectious Diseases (NIAID) and the HIV Vaccine Trials Network (HVTN). Researchers are hopeful that this technology developed by Moderna would be as successful as the m-RNA based Covid-19 vaccines.

The three experimental HIV mRNA vaccines include BG505 MD39.3 mRNA, BG505 MD39.3 gp151 mRNA and BG505 MD39.3 gp151 CD4KO mRNA. None of the three vaccine candidates can cause HIV infection. Researchers will evaluate if these vaccines will induce HIV neutralizing antibodies and T cell response that will be protective in case of future exposure to the virus. “Each investigational vaccine candidate is designed to present the spike protein found on the surface of HIV that facilitates entry into human cells. Each of the experimental vaccines encodes for different but highly related, stabilized proteins”.

The multicenter study will enrol 108 adults ages 18 to 55 years at 11 cities namely Birmingham, Boston, Los Angeles, New York City, Philadelphia, Pittsburgh, Rochester, New York and Seattle. The subjects would be grouped into six groups of 18 each. The first three groups are called Group A, while the rest of the three groups were collectively termed Group B. Each participant will receive three doses of any one of the three vaccines under study.

Group A will receive the intramuscular vaccine in doses of 100 µg at the first visit, at two months and then at six months. Safety will be examined two weeks after completion of the vaccination schedule. Once safety criteria are ensured, Group B participants would be administered 250 µg of the vaccine in the same schedule as Group A. Blood samples would be drawn along with FNAC of the lymph nodes at designated periods to assess immune response and safety. The trial will be over next year by July.

Source: National Institutes of Health, March 14, 2022