FluGen, Inc. today announced preliminary data from a human challenge trial with its investigational intranasal M2SR vaccine showing, for the first time, protection against a highly mismatched influenza virus. This major step toward demonstrating breadth of protection is key to developing a universal flu vaccine against flu viruses that have significantly drifted from the strains contained in the vaccines.
The goal of FluGen’s Phase 2 M2SR study was to test whether its flu vaccine could demonstrate the broad protection required during years when there is a mismatch between the vaccine and the circulating influenza strain. The topline results from a six-year mismatch confirm the strong results seen in Phase 1 immunogenicity and preclinical challenge studies.
The double-blind, placebo-controlled Phase 2 clinical trial of 99 healthy adults, sponsored by the U.S. Department of Defense, compared FluGen’s M2SR vaccine matching a virus from 2007 against a challenge with a live H3N2 influenza virus from the 2014-15 flu season. Study subjects were randomized 1:1 to receive either intranasal placebo, or a single intranasal dose of M2SR vaccine. The development of M2SR has also been supported by the National Institutes for Allergy and Infectious Diseases (NIAID) division of the National Institutes of Health (NIH).
According to the Centers for Disease Control and Prevention, the effectiveness of the marketed inactivated flu vaccine from the 2014-15 flu season was just 19 percent overall and close to zero percent in those 65 and older. The mismatch tested in the FluGen clinical study was significantly greater than the mismatch between the marketed injectable vaccine and the predominant circulating influenza virus in 2014-15.
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