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Phase 1 trial FluGen’s M2SR intranasal flu vaccine in elderly demonstrated benefit of coadministration

FluGen announced that it has published data from a 2022 Phase 1 trial of its M2SR intranasal flu vaccine coadministered with Fluzone high dose intramuscular inactivated influenza vaccine (IIV) in people aged 65 to 85 in Lancet Infectious Diseases. According to the company, the study, which was funded by the US Department of Defense, demonstrated that elderly people who received the high dose FluZone shot plus M2SR had a significantly greater immune response, including more mucosal antibodies in the nose and more serum antibodies, compared to those who received FluZone plus placebo.

The company said that coadministration with M2SR significantly raised serum antibodies against both matched and drifted strains of flu virus. In February 2019, FluGen reported positive data from a Phase 2 challenge trial, where M2SR manufactured with a strain of influenza from the 2008-2010 influenza seasons successfully provided protection against live H3N2 influenza virus from the 2014-15 flu season.

FluGen President and CEO Paul Radspinner commented, “The idea of delivering two vaccines in one sitting has become widely accepted. Imagine being at your local pharmacy for your annual flu shot and also receiving a quick nasal spray that would greatly enhance your chances not only of becoming seriously ill but of being infected at all. This combination solution could have a tremendous impact on the health of older adults. If H5N1 or any other mutating influenza strain were to begin infecting millions of people as SARS-CoV-2 did, imagine the benefits of combining an intranasal vaccine, which could stop most infections from occurring, with a strong antibody-based vaccine shot. The impact on human health could be unequalled in our history.”

Read the FluGen press release.

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published on July 15, 2024

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