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Enhanced immunogenicity of seasonal influenza vaccines in young children using MF59 adjuvant.
Pediatr Infect Dis J. 2009 Jul; 28(7):563-71.PI

Abstract

BACKGROUND

Children have high morbidity and hospitalization rates from seasonal influenza. Meta-analyses suggest that conventional inactivated influenza vaccines are of low efficacy in young children, making vaccines that induce greater and broader immune protection in this vulnerable population a medical priority. Adjuvanted influenza vaccines may offer a solution.

SUBJECTS AND METHODS

Unprimed healthy children (6 to <36 months) were enrolled in an observer-blinded study and randomly assigned to receive 2 doses of MF59-adjuvanted vaccine (Sub/MF59, n = 130) or nonadjuvanted split vaccine (split, n = 139); subgroups of these (n = 43 and 46, respectively) received a booster dose 1 year later. Safety and clinical tolerability were assessed after each dose. Hemagglutination inhibition antibody titers were measured against influenza A and B strains included in the formulation of the vaccines and against mismatched strains.

RESULTS

Clinical tolerability and safety were generally comparable between vaccine groups, though some transient, mild solicited reactions were more frequent in the Sub/MF59 group. Postvaccination hemagglutination inhibition antibody titers to all 3 vaccine strains were significantly higher with Sub/MF59 than with split vaccine (all comparisons P < 0.001) after each of the 3 vaccine doses. In addition, Sub/MF59 induced significantly higher cross-reactivity against A/H3N2 and A/H1N1 mismatched strains.

CONCLUSION

MF59-adjuvanted influenza vaccine was well tolerated in healthy young children after each of 3 doses and induced greater, longer-lasting, and broader immune responses than a nonadjuvanted split vaccine. The enhanced immunogenicity of the adjuvanted vaccine was most evident in very young children and for the B vaccine strain.

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Authors+Show Affiliations

Vesikari T
Vaccine Research Center, University of Tampere Medical School, Tampere, Finland. Timo.Vesikari@uta.fi
Pellegrini M
No affiliation info available
Karvonen A
No affiliation info available
Groth N
No affiliation info available
Borkowski A
No affiliation info available
O'Hagan DT
No affiliation info available
Podda A
No affiliation info available

MeSH

Adjuvants, ImmunologicAntibodies, ViralChild, PreschoolHemagglutination Inhibition TestsHumansImmunization, SecondaryInfantInfluenza A virusInfluenza B virusInfluenza VaccinesInfluenza, HumanMalePolysorbatesSqualeneVaccination

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19561422

Clinical Trial Links

Safety and Immunogenicity of 2 Commercially Available Influenza Vaccines in Children

Citation

Vesikari, Timo, et al. "Enhanced Immunogenicity of Seasonal Influenza Vaccines in Young Children Using MF59 Adjuvant." The Pediatric Infectious Disease Journal, vol. 28, no. 7, 2009, pp. 563-71.
Vesikari T, Pellegrini M, Karvonen A, et al. Enhanced immunogenicity of seasonal influenza vaccines in young children using MF59 adjuvant. Pediatr Infect Dis J. 2009;28(7):563-71.
Vesikari, T., Pellegrini, M., Karvonen, A., Groth, N., Borkowski, A., O'Hagan, D. T., & Podda, A. (2009). Enhanced immunogenicity of seasonal influenza vaccines in young children using MF59 adjuvant. The Pediatric Infectious Disease Journal, 28(7), 563-71. https://doi.org/10.1097/INF.0b013e31819d6394
Vesikari T, et al. Enhanced Immunogenicity of Seasonal Influenza Vaccines in Young Children Using MF59 Adjuvant. Pediatr Infect Dis J. 2009;28(7):563-71. PubMed PMID: 19561422.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Enhanced immunogenicity of seasonal influenza vaccines in young children using MF59 adjuvant. AU - Vesikari,Timo, AU - Pellegrini,Michele, AU - Karvonen,Aino, AU - Groth,Nicola, AU - Borkowski,Astrid, AU - O'Hagan,Derek T, AU - Podda,Audino, PY - 2009/6/30/entrez PY - 2009/6/30/pubmed PY - 2010/2/27/medline SP - 563 EP - 71 JF - The Pediatric infectious disease journal JO - Pediatr Infect Dis J VL - 28 IS - 7 N2 - BACKGROUND: Children have high morbidity and hospitalization rates from seasonal influenza. Meta-analyses suggest that conventional inactivated influenza vaccines are of low efficacy in young children, making vaccines that induce greater and broader immune protection in this vulnerable population a medical priority. Adjuvanted influenza vaccines may offer a solution. SUBJECTS AND METHODS: Unprimed healthy children (6 to <36 months) were enrolled in an observer-blinded study and randomly assigned to receive 2 doses of MF59-adjuvanted vaccine (Sub/MF59, n = 130) or nonadjuvanted split vaccine (split, n = 139); subgroups of these (n = 43 and 46, respectively) received a booster dose 1 year later. Safety and clinical tolerability were assessed after each dose. Hemagglutination inhibition antibody titers were measured against influenza A and B strains included in the formulation of the vaccines and against mismatched strains. RESULTS: Clinical tolerability and safety were generally comparable between vaccine groups, though some transient, mild solicited reactions were more frequent in the Sub/MF59 group. Postvaccination hemagglutination inhibition antibody titers to all 3 vaccine strains were significantly higher with Sub/MF59 than with split vaccine (all comparisons P < 0.001) after each of the 3 vaccine doses. In addition, Sub/MF59 induced significantly higher cross-reactivity against A/H3N2 and A/H1N1 mismatched strains. CONCLUSION: MF59-adjuvanted influenza vaccine was well tolerated in healthy young children after each of 3 doses and induced greater, longer-lasting, and broader immune responses than a nonadjuvanted split vaccine. The enhanced immunogenicity of the adjuvanted vaccine was most evident in very young children and for the B vaccine strain. SN - 1532-0987 UR - https://www.unboundmedicine.com/medline/citation/19561422/Enhanced_immunogenicity_of_seasonal_influenza_vaccines_in_young_children_using_MF59_adjuvant_ L2 - https://doi.org/10.1097/INF.0b013e31819d6394 DB - PRIME DP - Unbound Medicine ER -