FluGen, Inc., a clinical-stage vaccine company transforming vaccine efficacy in infectious respiratory diseases, today announced the dosing of its first subject in an unprecedented study of older adults ages 65-85 years. The study will evaluate the safety, tolerability, and immunological response to FluGen’s investigational supra-seasonal, live, single-replication, intranasal M2SR influenza (flu) vaccine, and high dose inactivated vaccine (IIV). There is a demonstrated unmet need for improved flu vaccine options, as current injectable vaccines primarily generate hemagglutinin (HA) antibodies and have shown only modest efficacy in most flu seasons. Funded by the U.S. Department of Defense (DOD), this study will evaluate M2SR and high dose IIV alone, and dosed concomitantly, in healthy adults 65-85 years of age, a population considered highly vulnerable to mortality from flu.
“We have seen numerous approaches to solving the challenge of influenza vaccine efficacy over the past decade, but despite these efforts, none have achieved the efficacy needed to improve health outcomes,” said Yoshihiro Kawaoka, Professor of Virology, University of Wisconsin and FluGen co-founder. “This study is important, as it is the first of its kind to combine intranasal vaccine delivery with intramuscular shots to determine the potential for boosting vaccine efficacy and reducing transmission and virus shedding.”