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

@article{citeulike:5435660, abstract = {Background. Immunization 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. Methods. This 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, [Formula: see text]; elderly persons 61 years, [Formula: see text]), received a single intramuscular vaccination. Immunogenicity was assessed 21 days later by hemagglutination inhibition assay. Reactogenicity was assessed using self-completed diary cards. Results. The 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\%; [Formula: see text]) and elderly (9\% vs 5\%; [Formula: see text]) vaccinees. Conclusions. CCIV 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 registration. ClinicalTrials.gov identifier: NCT00492063 .}, author = {Szymczakiewicz-Multanowska, Agnieszka and Groth, Nicola and Bugarini, Roberto and Lattanzi, Maria and Casula, Daniela and Hilbert, Anne and Tsai, Theodore and Podda, Audino}, citeulike-article-id = {5435660}, citeulike-linkout-0 = {http://dx.doi.org/10.1086/605505}, citeulike-linkout-1 = {http://view.ncbi.nlm.nih.gov/pubmed/19673651}, citeulike-linkout-2 = {http://www.hubmed.org/display.cgi?uids=19673651}, citeulike-linkout-3 = {http://www.journals.uchicago.edu/doi/abs/10.1086/605505}, day = {12}, doi = {10.1086/605505}, issn = {0022-1899}, journal = {The Journal of infectious diseases}, keywords = {flu, subunit, vaccine}, month = {August}, number = {0}, pages = {000}, posted-at = {2009-08-18 06:22:43}, priority = {2}, title = {Safety and Immunogenicity of a Novel Influenza Subunit Vaccine Produced in Mammalian Cell Culture.}, url = {http://dx.doi.org/10.1086/605505}, volume = {0}, year = {2009} }

TY - JOUR ID - citeulike:5435660 L3 - citeulike-article-id:5435660 N2 - Background. Immunization 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. Methods. This 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, [Formula: see text]; elderly persons 61 years, [Formula: see text]), received a single intramuscular vaccination. Immunogenicity was assessed 21 days later by hemagglutination inhibition assay. Reactogenicity was assessed using self-completed diary cards. Results. The 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%; [Formula: see text]) and elderly (9% vs 5%; [Formula: see text]) vaccinees. Conclusions. CCIV 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 registration. ClinicalTrials.gov identifier: NCT00492063 . IS - 0 JF - The Journal of infectious diseases SN - 0022-1899 EP - 000 TI - Safety and Immunogenicity of a Novel Influenza Subunit Vaccine Produced in Mammalian Cell Culture. VL - 0 SP - 000 KW - flu KW - subunit KW - vaccine AU - Szymczakiewicz-Multanowska, Agnieszka AU - Groth, Nicola AU - Bugarini, Roberto AU - Lattanzi, Maria AU - Casula, Daniela AU - Hilbert, Anne AU - Tsai, Theodore AU - Podda, Audino PY - 2009/08/12/ UR - http://dx.doi.org/10.1086/605505 ER -