Japanese pharmaceutical firms Astellas Pharma and UMN Pharma have released results for two Phase III clinical trials of the recombinant seasonal influenza HA vaccine ASP7374.
Out of the two trials, one enrolled 900 healthy volunteers aged from 20 to 64 years to compare the immunogenicity and safety of subcutaneously administered ASP7374 with approved egg-derived trivalent inactivated vaccine and to prove non-inferiority of ASP7374 to the egg-derived vaccine.
This trial demonstrated non-inferiority of the recombinant seasonal influenza HA vaccine ASP7374 in comparison with the egg-based vaccine in terms of immunogenicity and no major safety problems were observed.
Astellas is carrying out this trial following the successfully completed clinical trial among 1,060 elderly volunteers.
Some 55 healthy volunteers aged 61 and over were enrolled in the second trial, which assessed the immunogenicity and safety of intramuscularly-administered ASP7374.
The trial showed favourable immunogenicity and no major safety problem was observed.
The recombinant seasonal influenza HA vaccine ASP7374, which contains three different strains of antigens has been produced by a cell-culture manufacturing method using the Baculovirus Expression Vector System (BEVS), a next-generation technology platform for manufacturing biopharmaceutical products.
In January 2013, Protein Sciences secured approval of this vaccine from the US Food and Drug Administration (FDA).
According to the companies, the results of these clinical trials demonstrated favourable potential of the recombinant seasonal influenza HA vaccine ASP7374 produced by a cell-culture manufacturing method employing the BEVS.
Currently, the companies are preparing for the application for marketing approval of ASP7374 in Japan.
Image: a 3D model of an influenza virus. Photo: courtesy of Magnus Manske.