FluGen has published the results of a Phase I trial showing that its intranasal flu vaccine, M2SR, when used in combination with Sanofi’s Fluzone high dose (Fluzone HD) inactivated influenza vaccine, increases the efficacy of the Fluzone HD vaccine.
The Phase Ib trial (NCT05163847) enrolled 305 participants aged 65-85 years who were randomised to receive either M2SR, Fluzone HD, the combination therapy of M2SR and Fluzone HD, or a placebo. The study was funded by the US Department of Defense (DOD) and the data was published in the Lancet journal.
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“Influenza continues to be a major cause of seasonal respiratory epidemics with significant morbidity and mortality, especially in older adults. Current vaccines fall short in three main areas – they don’t last long enough, they don’t protect against viruses that mutate and they don’t block the initial infection in the upper respiratory tract,” said Robert Belshe, founder of Saint Louis University’s Center for Vaccine Development
“The results from this study represent a potential solution that might save millions of older adults from getting sick or worse.”
M2SR vaccine is an intranasal H3N2 M2-deficient single-replication (M2SR) influenza vaccine. The intranasal administration invokes mucosal antibodies and prevents influenza viruses from entering the nasal mucosa. Standard flu vaccines such as Fluzone HD elicit an antibody response in the blood and help combat the virus after it enters the body. Therefore, combining both intranasal and standard flu vaccines can provide total coverage.
The Phase Ib trial met its primary endpoint of safety and tolerability. The commonly observed side effects include rhinorrhoea, nasal congestion, sore throat, and injection site pain.
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By GlobalDataThe development of influenza vaccines has seen an uptick in recent years. In June, Moderna reported positive Phase III trial (NCT06097273) data for its mRNA vaccine candidate, Spikevax, for the combined treatment of influenza and Covid-19. The trial evaluated Spikevax against Fluzone HD in the elderly population and against GSK’s Fluraix in the younger age group.
Curevac and GSK are also investigating an influenza A (H5N1) pre-pandemic vaccine candidate in a Phase I/II trial. The vaccine targets the H5N1 avian influenza virus.
