HIV Vaccine Trials: Human Testing of Three mRNA Vaccines by NIH

One of the earliest experiments into mRNA technology for HIV is in its early stages. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health has begun a Phase 1 clinical research to evaluate three experimental HIV vaccines based on the messenger RNA (mRNA) platform, which is also the foundation for several approved COVID-19 vaccines. The NIAID-sponsored HVTN 302 trial is being conducted by the Fred Hutchinson Cancer Research Center’s HIV Vaccine Trials Network (HVTN), which is situated in Seattle.

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

An mRNA vaccine works by delivering genetic material that instructs the body to manufacture a protein fragment of a target pathogen (such as a virus), which the immune system recognises and remembers in order to mount a vigorous response if that pathogen is later exposed. The following three experimental HIV mRNA vaccines will be investigated in the HVTN 302 study to establish whether they are safe and capable of inducing an immune response: BG505 MD39.3, BG505 MD39.3 gp151, and BG505 MD39.3 gp151 CD4KO are the three genes. Each possible vaccine under consideration is intended to deliver the spike protein, which is found on the surface of HIV and helps it enter human cells. Each of the experimental vaccines encodes for a different but closely related stable protein. None of the three proposed vaccinations have the ability to transmit HIV.

To design and develop the specific mRNA sequences used in the vaccines, scientists from the Bill & Melinda Gates Foundation-funded IAVI Neutralising Antibody Centre at Scripps and the NIAID-funded Scripps Consortium for HIV/AIDS Vaccine Development (CHAVD) at the Scripps Research Institute collaborated with scientists from Cambridge, Massachusetts-based Moderna, Inc. Moderna manufactured the investigational vaccines under a contract funded by the NIAID.

The HVTN 302 study, led by Sharon Riddler, M.D., of the University of Pittsburgh, and Jesse Clark, M.D., of the University of California Los Angeles, will enrol up to 108 adults between the ages of 18 and 55 in 11 locations including Birmingham, Alabama, Boston, Los Angeles, New York City, Philadelphia, Pittsburgh, Rochester, New York, and Seattle. Each of the six groups will get three injections of one of the experimental vaccines, with each participant assigned to one of the groups at random. For the first three groups (Group A), each of which has 18 people, the initial visit, month two, and month six will all contain intramuscular injections of 100 micrograms (mcg) of the assigned vaccine candidate. Participants in Group A will be evaluated two weeks after the first vaccination to ensure that safety requirements have been met. In this situation, 250 mcg of the selected experimental vaccine will be given to each of the remaining three groups of 18 people (Group B), followed by injections two and six months later.

Blood and lymph node fine-needle aspiration samples obtained at various stages during the trial will be analysed for immunological responses and safety. Clinical experts will keep a close watch on participant safety during the experiment. The clinical investigation is expected to be completed by July 2023.

More information on the HVTN 302 study may be found on ClinicalTrials.gov with the identifier NCT05217641.

NIAID conducts and sponsors research at the National Institutes of Health (NIH), throughout the country, and abroad to better understand the causes of infectious and immune-mediated diseases, as well as to develop better strategies of preventing, detecting, and treating these illnesses. The NIAID website contains press releases, information sheets, and other publications related to the institution.

The National Institutes of Health (NIH): The National Institutes of Health (NIH), the country’s medical research body, is one of the Department of Health and Human Services’ 27 Institutes and Centres. The National Institutes of Health (NIH) is the primary federal agency in charge of conducting and supporting basic, clinical, and translational medical research. Its research focuses on determining the causes, prognoses, and treatments for both common and unusual diseases. For more information about the NIH and its activities, go to www.nih.gov.

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