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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 A(H1N1) pre-vaccination.
PLoS One 2013; 8(8):e70866Plos

Abstract

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 A(H1N1) in 68% of both younger and older adults, against A(H3N2) in 53% and 27%, and against the B influenza strain in 35% and 17%. Antibody titers of 40 or more were observed against A(H1N1) in 87% and 90% of younger and older adults, against A(H3N2) in 98% and 98%, and against the B influenza strain in 93% and 90%. Pre-vaccination antibody titers were protective against A(H1N1), A(H3N2) and B in 38%, 58% and 58%, respectively, of younger and in 43%, 88% and 70% of older adults. Among subjects with previous A(H1N1) vaccination only 48% of younger and 47% of older adults had protective A(H1N1) 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.govNCT01422512.

Authors+Show Affiliations

Department of Tropical Medicine, Infectious Diseases and Nephrology, University of Rostock, Rostock, Germany.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23976960

Citation

Loebermann, Micha, et al. "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 A(H1N1) Pre-vaccination." PloS One, vol. 8, no. 8, 2013, pp. e70866.
Loebermann M, Voss U, Meyer S, et al. 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 A(H1N1) pre-vaccination. PLoS ONE. 2013;8(8):e70866.
Loebermann, M., Voss, U., Meyer, S., Bosse, D., Fritzsche, C., Klammt, S., ... Reisinger, E. C. (2013). 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 A(H1N1) pre-vaccination. PloS One, 8(8), pp. e70866. doi:10.1371/journal.pone.0070866.
Loebermann M, et al. 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 A(H1N1) Pre-vaccination. PLoS ONE. 2013;8(8):e70866. PubMed PMID: 23976960.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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 A(H1N1) pre-vaccination. AU - Loebermann,Micha, AU - Voss,Ulrich, AU - Meyer,Seetha, AU - Bosse,Dietrich, AU - Fritzsche,Carlos, AU - Klammt,Sebastian, AU - Frimmel,Silvius, AU - Riebold,Diana, AU - Reisinger,Emil C, Y1 - 2013/08/16/ PY - 2012/10/22/received PY - 2013/06/19/accepted PY - 2013/8/27/entrez PY - 2013/8/27/pubmed PY - 2014/4/9/medline SP - e70866 EP - e70866 JF - PloS one JO - PLoS ONE VL - 8 IS - 8 N2 - UNLABELLED: 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 A(H1N1) in 68% of both younger and older adults, against A(H3N2) in 53% and 27%, and against the B influenza strain in 35% and 17%. Antibody titers of 40 or more were observed against A(H1N1) in 87% and 90% of younger and older adults, against A(H3N2) in 98% and 98%, and against the B influenza strain in 93% and 90%. Pre-vaccination antibody titers were protective against A(H1N1), A(H3N2) and B in 38%, 58% and 58%, respectively, of younger and in 43%, 88% and 70% of older adults. Among subjects with previous A(H1N1) vaccination only 48% of younger and 47% of older adults had protective A(H1N1) 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.govNCT01422512. SN - 1932-6203 UR - https://www.unboundmedicine.com/medline/citation/23976960/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_A_H1N1__pre_vaccination_ L2 - http://dx.plos.org/10.1371/journal.pone.0070866 DB - PRIME DP - Unbound Medicine ER -