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National Institutes of Health Launches Trial of 3 mRNA HIV Vaccines

With 3 vaccine candidates, the National Institutes of Health (NIH) is launching one of the first trials to examine the safety and efficacy of mRNA technology in HIV vaccination.

The National Institutes of Health (NIH) announced today the launch of a phase 1 clinical trial to evaluate 3 HIV vaccines. The experimental vaccines utilize similar messenger RNA (mRNA) technology to the Pfizer-BioNTech and Moderna COVID-19 vaccines.

“Finding an HIV vaccine has proven to be a daunting scientific challenge,” said Anthony Fauci, MD, NIAID director. “With the success of safe and highly effective COVID-19 vaccines, we have an exciting opportunity to learn whether mRNA technology can achieve similar results against HIV infection.”

The HIV Vaccine Trials Network (HVTN) is conducting the trial based out of the Fred Hutchinson Cancer Research Center in Seattle. The trial, HVTN 302, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and expected to be completed by July 2023.

The study will examine whether 3 HIV vaccines (BG505 MD39.3 mRNA, BG505 MD39.3 gp151 mRNA, and BG505 MD39.3 gp151 CD4KO mRNA) can safely induce an immune response. The investigational vaccines are designed to target the spike protein on the surface of the HIV cell to inhibit it from entering human cells.

mRNA vaccines deliver a piece of genetic material that enables the body to make a protein fragment of the target pathogen. The immune system remembers the pathogen to attack it later.

The HVTN 302 study plans to enroll no more than 108 adults aged 18-55 years old. The study will run at 11 sites in Birmingham, Boston, Los Angeles, New York City, Philadelphia, Pittsburgh, Rochester, and Seattle. All participants will be randomly assigned to 1 of 6 groups, each of whom receive 3 doses of 1 of the experimental vaccines. The first 3 groups will receive intramuscular injections of 100 mcg of their respective vaccine candidate at enrollment, month 2, and month 6. The participants will be evaluated for safety after 2 weeks, and if satisfactory, the other 3 participant groups will receive 3 separate injections with 250 mcg of their assigned experimental vaccine.

Though there have been 3 cases of people considered functionally “cured” of HIV, there is no widespread cure for the infection. Worldwide, HIV infections are on the decline, largely due increased rollout of pre-exposure prophylaxis (PrEP), increased testing, and initiating antiretroviral therapy at the time of HIV diagnosis. However, certain minority demographics, like men who have sex with men, Black or Latinx people, and people who inject drugs, are disproportionately likely to contract HIV. Any efforts to improve HIV preventing, diagnosing, and treating are potentially lifesaving.