NIH Researchers Begin Clinical Trials on a Universal Influenza Vaccine

The NIH’s National Institute of Allergy and Infectious Disease (NIAID) Vaccine Research Center (VCR) researchers have begun phase 1 clinical trials on a universal mRNA influenza vaccine. The researchers at Duke University in Durham, North Carolina, started enrolling patients in the early-stage clinical trial called H1ssF-3928 mRNA-LNP. The research will be conducted through the Collaborative Influenza Vaccine Innovation Centers (CIVICs)

According to the NIH press release, the study plans to recruit 50 healthy patients between 18 and 49, starting by assigning a minimum of 30 patients to one of the following doses of the experimental vaccine: 10, 25, or 50 micrograms (µg).

Based on the results of the initial arm of the study, 10 participants will be enrolled in the second arm and receive an optimal dose. Finally, the study will have a control group of participants who will get the quadrivalent seasonal flu vaccine.

“A universal influenza vaccine would be a major public health achievement and could eliminate the need for both annual development of seasonal influenza vaccines, as well as the need for patients to get a flu shot each year,” said Acting NIAID Director Hugh Auchincloss, MD, in the NIH press release. “Moreover, some strains of influenza virus have significant pandemic potential. A universal flu vaccine could serve as an important line of defense against the spread of a future flu pandemic.”

Data from the CDC suggests that between 12,000 and 52,000 people die of influenza infection in the United States annually, with a significantly higher risk of severe and fatal infections among unvaccinated individuals. However, the frequent influenza virus mutation means that vaccines must be regularly updated and may not protect against all viral forms.

Developing a universal vaccine may ease the vaccination burden and provide broader protection for vaccinated individuals.

According to the NIH press release, this vaccine — like a similar vaccine in development — focuses on the stem of the hemagglutinin protein of the flu virus. The component of the protein evolves slowly and is consistent across most variations of the virus. Rather than focusing on the head of the protein, which rapidly evolves, an emphasis on the protein’s tail may provide long-lasting immunity.