Clinical Trial to Evaluate the Safety and Immunogenicity of a Trivalent Surface Antigen Seasonal Influenza Vaccine Produced in Mammalian Cell Culture and Administered to Young and Elderly Adults with and without AH1N1 Pre-VaccinatReport as inadecuate




Clinical Trial to Evaluate the Safety and Immunogenicity of a Trivalent Surface Antigen Seasonal Influenza Vaccine Produced in Mammalian Cell Culture and Administered to Young and Elderly Adults with and without AH1N1 Pre-Vaccinat - Download this document for free, or read online. Document in PDF available to download.

Vaccination against influenza is an important means of reducing morbidity and mortality in subjects at risk. The prevalent viral strains responsible for seasonal epidemics usually change annually, but the WHO recommendations for the 2011-2012-season in the Northern hemisphere included the same antigens as for the previous season.We conducted a single-center, single-arm study involving 62 younger 18–60 years and 64 older >60 years adults to test the immunogenicity, safety and tolerability of a trivalent surface antigen, inactivated influenza vaccine produced in mammalian cell-culture. The vaccine contained 15 µg hemagglutinin of each of the virus strains recommended for the 2011–2012 Northern hemisphere winter season A-California-7-09 H1N1-; A-Perth-16-09 H3N2-; B-Brisbane-60-08-like strain in a non-adjuvanted preservative-free formulation. Antibody response was measured by hemagglutination inhibition 21 days after immunization. Adverse events and safety were assessed using subject diary cards and telephone interviews.Seroconversion or a 4-fold antibody increase in antibody titers was detectable against AH1N1 in 68% of both younger and older adults, against AH3N2 in 53% and 27%, and against the B influenza strain in 35% and 17%. Antibody titers of 40 or more were observed against AH1N1 in 87% and 90% of younger and older adults, against AH3N2 in 98% and 98%, and against the B influenza strain in 93% and 90%. Pre-vaccination antibody titers were protective against AH1N1, AH3N2 and B in 38%, 58% and 58%, respectively, of younger and in 43%, 88% and 70% of older adults. Among subjects with previous AH1N1 vaccination only 48% of younger and 47% of older adults had protective AH1N1 antibodies at inclusion. Adverse reactions were generally mild. The most frequently reported reactions were pain at the injection site, myalgia and fatigue.The vaccine generated protective antibodies against all three viral strains and had an acceptable safety profile in both younger and older adults.

Trial Registration

ClinicalTrials.gov NCT01422512



Author: Micha Loebermann , Ulrich Voss, Seetha Meyer, Dietrich Bosse, Carlos Fritzsche, Sebastian Klammt, Silvius Frimmel, Diana Riebold,

Source: http://plos.srce.hr/



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