Preclinical immunogenicity and safety evaluation of MDCK cell-derived quadrivalent influenza virus subunit vaccine.

To address the limitations of egg-based influenza vaccine production, serum-free suspension culture of Madin-Darby Canine Kidney cells (MDCK) has emerged as a promising alternative. In this study, a quadrivalent influenza virus subunit vaccine was developed using this platform by culturing four viral strains, followed by purification, inactivation, and formulation. Preclinical safety evaluations in rats, rabbits, and guinea pigs demonstrated no systemic toxicity. In mice, immunization with the vaccine elicited significant hemagglutination inhibition and microneutralization antibodies against H1N1, H3N2, BY, and BV strains at 28 and 42 days post-vaccination. These results indicate that the vaccine candidate possesses a favorable safety profile and induces robust immunogenicity.