Researchers at the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID) have started signing up people to volunteer for an experimental universal influenza vaccine called H1ssF-3928 mRNA-LNP.
The first phase of the vaccine trial will test how safe the vaccine is and its capacity to elicit an immunological response, an NIAID press release 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,” Dr. Hugh Auchincloss, acting NIAID Director, said in the 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.”
Volunteers in the first phase of the vaccine trials are being enrolled at Duke University in Durham, NC, the release stated. The trial pool will consist of up to 50 healthy people between the ages of 18 and 49. The vaccine will be administered in doses of 10, 25, and 50 micrograms to three groups of study participants, each consisting of ten people. An additional 10 participants will be enlisted to obtain the optimal dosage after analyzing data from the three groups to determine the optimal dosage.
A group of participants who will be vaccinated with the latest seasonal influenza vaccine will also be included in the study. According to the release, this will give the researchers the ability to compare the candidate vaccine's immunogenicity and safety to that of the current seasonal flu vaccinations. Participants will undergo routine testing to determine the vaccine's safety and effectiveness. The volunteers will be scheduled for follow-up sessions for a year after receiving the shot, the release said.
The Centers for Disease Control and Prevention estimates that in the decade leading up to 2020, flu-related deaths ranged from 12,000 to 52,000 people, the release said. Receiving a flu shot each year is effective at reducing the spread and severity of flu but doesn't guarantee protection from all flu strains.