FluGen has dosed the first subject in a new clinical trial evaluating the M2SR vaccine to treat subjects with an influenza virus genetically mismatched by six years from the influenza strain utilised in the vaccine.
As part of the trial, which is being conducted by SGS in Belgium, around 96 patients will be randomised at a 1:1 ratio to receive either intranasal placebo, or intranasal M2SR vaccine, built with the A/Brisbane/10/2007 H3N2 strain of influenza.
After that, patients will be challenged intranasally with the A/Belgium/4217/2015 H3N2 influenza virus, a genetically drifted virus that caused outbreaks of influenza in 2015.
Subjects will be followed for four months.
The trial’s primary endpoint is influenza infectivity in the placebo group compared to the group vaccinated with M2SR. It will also analyse the safety and immunogenicity data of all the subjects.
The trial is supported by a $14.4m grant from the US Department of Defense.
FluGen clinical advisory board chair Robert Belshe said: “The potential mismatch between current influenza vaccines and the circulating strains is one of the biggest annual challenges for prevention of influenza.
“Even in years when we do get a good match with all strains, traditional vaccine effectiveness is often less than 50%.
“In years where we do not closely match the vaccine to circulating virus strains, like this past flu season, it can be much lower, and low efficacy puts people at risk for potentially severe illness.”
The investigational M2SR vaccine uses a M2 deleted, single replication (M2SR) influenza virus to challenge its target.
The M2 gene is vital for the influenza virus to spread in the patient and the deletion of the gene restricts the virus to a single replication cycle in the host.