Phase 1 trial of an experimental universal influenza vaccine has begun at the Duke University in Durham, North Carolina. The vaccine candidate H1ssF-3928 mRNA-LNP has been developed by National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center (VRC) using the messenger RNA (mRNA) platform. The trial (NCT05755620) will examine the safety and immunogenicity of the vaccine.

Fifty healthy adult volunteers, aged 18-49 years, will be recruited for the trial. Three groups, with 10 participants each, would be administered the vaccine in doses of 10, 25 and 50 µg (single dose). The trial will initially start with 10 µg and move on to the next higher dose if there are no safety concerns. Analysis of data will determine the optimum dose of the experimental vaccine, which would be given to another group of 10 subjects. Another group would be given a quadrivalent seasonal influenza vaccine currently in use. The follow-up period would be one year after the vaccination during which the safety, which is the primary objective of the trial, and efficacy of the experimental vaccine would be regularly assessed and also compare it with the available flu vaccines.

Hugh Auchincloss, M.D., the Acting Director of NIAID said, “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. A universal flu vaccine could serve as an important line of defense against the spread of a future flu pandemic.”

The trial is expected to be completed by August next year.

Source

1. NIH News release. Available at https://www.nih.gov/news-events/news-releases/clinical-trial-mrna-universal-influenza-vaccine-candidate-begins. May 15, 2023. Accessed on May 20, 2023.