Safety and Immunogenicity of a Novel Influenza Subunit Vaccine Produced in Mammalian Cell Culture

• Published in: The Journal of infectious diseases Vol. 200; no. 6; pp. 841 - 848
• Main Authors: Szymczakiewicz-Multanowska, Agnieszka, Groth, Nicola, Bugarini, Roberto, Lattanzi, Maria, Casula, Daniela, Hilbert, Anne, Tsai, Theodore, Podda, Audino
• Format: Journal Article
• Language: English
• Published: Oxford The University of Chicago Press 15-09-2009; University of Chicago Press; Oxford University Press
• Subjects: Adolescent; Adult; Age; Aged; Animals; Antibodies, Viral - blood; Applied microbiology; Biological and medical sciences; Cell culture techniques; Cell Line; Control groups; Cultured cells; Dogs; Female; Fundamental and applied biological sciences. Psychology; Humans; Immune response; Infectious diseases; Influenza A Virus, H1N1 Subtype - immunology; Influenza A Virus, H3N2 Subtype - immunology; Influenza B virus - immunology; Influenza vaccines; Influenza Vaccines - adverse effects; Influenza Vaccines - immunology; Male; Medical sciences; Microbiology; Middle Aged; Older adults; Orthomyxoviridae; Vaccination; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Vaccines, Subunit - adverse effects; Vaccines, Subunit - immunology; Viruses; Young Adult; Infection; Cell culture; Vertebrata; Mammalia; Immunogenicity; Microbiology; Viral disease; Influenza A; Vaccine; Subunit
• ISSN: 0022-1899; 1537-6613
• DOI: 10.1086/605505

BackgroundImmunization remains the best prevention strategy for influenza, but production constraints for egg-based influenza vaccines have prompted the development of innovative cell culture manufacturing processes. Here, we describe a novel cell culture–derived influenza vaccine (CCIV) produced in Madin-Darby canine kidney cells MethodsThis phase 3, observer-blind, randomized, multicenter study in Poland compared the immunogenicity of a CCIV and a conventional egg-based vaccine. Participants, stratified by age (adults 18–60 years, n=1300; elderly persons ⩾61 years, n=1354), received a single intramuscular vaccination. Immunogenicity was assessed 21 days later by hemagglutination inhibition assay. Reactogenicity was assessed using self-completed diary cards ResultsThe immunogenicity of CCIV was noninferior to that of the conventional vaccine for all 3 vaccine strains in both age groups, regardless of underlying health status. Both vaccines fulfilled European Union registration criteria and were well tolerated, with similar incidences of solicited local and systemic reactions in both age groups; the only significant difference was an increased frequency of mild or moderate pain with CCIV than the conventional vaccine among adult (22% vs 17%; P<.05) and elderly (9% vs 5%; P<.001) vaccinees ConclusionsCCIV was well tolerated and highly immunogenic in adults 18 years of age or older. Cell culture may offer greater flexibility of supply during periods of high demand for both seasonal and pandemic vaccines Trial registrationClinicalTrials.gov identifier: NCT00492063