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Enhanced and persistent antibody response against homologous and heterologous strains elicited by a MF59-adjuvanted influenza vaccine in infants and young children.
Vaccine. 2014 Oct 21; 32(46):6146-56.V

Abstract

BACKGROUND

Non-adjuvanted seasonal influenza vaccines show only modest efficacy in young children. This study compared the immunogenicity, reactogenicity and safety of the MF59-adjuvanted trivalent subunit vaccine (aTIV) with two non-adjuvanted trivalent vaccines, TIV-1, the non-adjuvanted version of aTIV, and TIV-2, a split virion vaccine.

METHODS

6078 children received two doses of aTIV (n=3125), TIV-1 (n=1479), or TIV-2 (n=1474) four weeks apart (Days 1 and 29). Children aged 6 to <36 months and 36 to <72 months received 0.25 mL and 0.50 mL doses, respectively. Immunogenicity was assessed by hemagglutination inhibition (HI) assay (n=2435) on Days 1, 29, 50 and 209. Safety was assessed up to Day 394.

RESULTS

After the second vaccination (Day 50), the aTIV group showed significantly higher geometric mean HI titers and seroconversion rates than the TIV-1 or TIV-2 groups against all homologous and heterologous strains. The difference was enhanced at HI titers ≥110. aTIV elicited a faster, more persistent antibody response, with significantly higher titers in the aTIV group after one vaccination (Day 29) and after six months (Day 209) than in either TIV group. aTIV was more reactogenic than were TIV-1 and TIV-2 but rates of severe adverse events were very low for all three vaccines.

CONCLUSION

In infants and young children, the MF59-adjuvanted vaccine induced substantially faster (after one dose), higher, persistent HI titers than the non-adjuvanted vaccines, with consistently higher seroprotection rates at increased threshold HI titers. This trial is registered at clinicaltrials.gov: NCT01346592.

Links

Publisher Full Text (DOI)

Authors+Show Affiliations

Melbourne School of Population and Global Health, and the Murdoch Childrens Research Institute, University of Melbourne, Melbourne, Australia. Electronic address: t.nolan@unimelb.edu.au.

Philippine General Hospital, University of the Philippines Manila, Manila, Metro Manila, Philippines.

Instituto Médico Rio Cuarto, Cordoba, Cordoba Province, Argentina.

Newtown Clinical Research Centre, Johannesburg, Gauteng Province, South Africa.

Chris Hani Baragwanath Hospital, University of Witwatersrand, Johannesburg, Gauteng Province, South Africa.

Research Institute for Tropical Medicine, Muntinlupa, Metro Manila, Philippines.

Novartis Vaccines and Diagnostics, Inc., Cambridge, MA, USA.

Novartis Vaccines and Diagnostics, Inc., Cambridge, MA, USA.

Novartis Vaccines and Diagnostics, Inc., Cambridge, MA, USA.

Nazaire-Bermal N

Novartis Vaccines and Diagnostics, Inc., Cambridge, MA, USA.

Novartis Vaccines and Diagnostics, Inc., Cambridge, MA, USA.

Novartis Vaccines and Diagnostics, Inc., Cambridge, MA, USA.

Novartis Vaccines and Diagnostics, Inc., Cambridge, MA, USA.

MeSH

Adjuvants, ImmunologicAntibodies, ViralAntibody FormationChild, PreschoolFemaleHemagglutination Inhibition TestsHumansInfantInfluenza A Virus, H1N1 SubtypeInfluenza A Virus, H3N2 SubtypeInfluenza B virusInfluenza VaccinesInfluenza, HumanMalePolysorbatesSingle-Blind MethodSqualeneVaccines, Subunit

Pub Type(s)

Clinical Trial, Phase III

Comparative Study

Journal Article

Multicenter Study

Randomized Controlled Trial

Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25223266

Clinical Trial Links

Clinical trial which this article describes

Citation

Nolan, Terry, et al. "Enhanced and Persistent Antibody Response Against Homologous and Heterologous Strains Elicited By a MF59-adjuvanted Influenza Vaccine in Infants and Young Children." Vaccine, vol. 32, no. 46, 2014, pp. 6146-56.

Nolan T, Bravo L, Ceballos A, et al. Enhanced and persistent antibody response against homologous and heterologous strains elicited by a MF59-adjuvanted influenza vaccine in infants and young children. Vaccine. 2014;32(46):6146-56.

Nolan, T., Bravo, L., Ceballos, A., Mitha, E., Gray, G., Quiambao, B., Patel, S. S., Bizjajeva, S., Bock, H., Nazaire-Bermal, N., Forleo-Neto, E., Cioppa, G. D., & Narasimhan, V. (2014). Enhanced and persistent antibody response against homologous and heterologous strains elicited by a MF59-adjuvanted influenza vaccine in infants and young children. Vaccine, 32(46), 6146-56. https://doi.org/10.1016/j.vaccine.2014.08.068

Nolan T, et al. Enhanced and Persistent Antibody Response Against Homologous and Heterologous Strains Elicited By a MF59-adjuvanted Influenza Vaccine in Infants and Young Children. Vaccine. 2014 Oct 21;32(46):6146-56. PubMed PMID: 25223266.

* Article titles in AMA citation format should be in sentence-case

TY - JOUR T1 - Enhanced and persistent antibody response against homologous and heterologous strains elicited by a MF59-adjuvanted influenza vaccine in infants and young children. AU - Nolan,Terry, AU - Bravo,Lulu, AU - Ceballos,Ana, AU - Mitha,Essack, AU - Gray,Glenda, AU - Quiambao,Beatriz, AU - Patel,Sanjay S, AU - Bizjajeva,Svetlana, AU - Bock,Hans, AU - Nazaire-Bermal,Nancy, AU - Forleo-Neto,Eduardo, AU - Cioppa,Giovanni Della, AU - Narasimhan,Vas, Y1 - 2014/09/16/ PY - 2014/02/17/received PY - 2014/07/28/revised PY - 2014/08/27/accepted PY - 2014/9/17/entrez PY - 2014/9/17/pubmed PY - 2015/4/22/medline KW - (www.clinicaltrials.gov): NCT01346592 KW - Adjuvant KW - Children KW - Fluad(®) KW - Influenza vaccine KW - MF59 SP - 6146 EP - 56 JF - Vaccine JO - Vaccine VL - 32 IS - 46 N2 - BACKGROUND: Non-adjuvanted seasonal influenza vaccines show only modest efficacy in young children. This study compared the immunogenicity, reactogenicity and safety of the MF59-adjuvanted trivalent subunit vaccine (aTIV) with two non-adjuvanted trivalent vaccines, TIV-1, the non-adjuvanted version of aTIV, and TIV-2, a split virion vaccine. METHODS: 6078 children received two doses of aTIV (n=3125), TIV-1 (n=1479), or TIV-2 (n=1474) four weeks apart (Days 1 and 29). Children aged 6 to <36 months and 36 to <72 months received 0.25 mL and 0.50 mL doses, respectively. Immunogenicity was assessed by hemagglutination inhibition (HI) assay (n=2435) on Days 1, 29, 50 and 209. Safety was assessed up to Day 394. RESULTS: After the second vaccination (Day 50), the aTIV group showed significantly higher geometric mean HI titers and seroconversion rates than the TIV-1 or TIV-2 groups against all homologous and heterologous strains. The difference was enhanced at HI titers ≥110. aTIV elicited a faster, more persistent antibody response, with significantly higher titers in the aTIV group after one vaccination (Day 29) and after six months (Day 209) than in either TIV group. aTIV was more reactogenic than were TIV-1 and TIV-2 but rates of severe adverse events were very low for all three vaccines. CONCLUSION: In infants and young children, the MF59-adjuvanted vaccine induced substantially faster (after one dose), higher, persistent HI titers than the non-adjuvanted vaccines, with consistently higher seroprotection rates at increased threshold HI titers. This trial is registered at clinicaltrials.gov: NCT01346592. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/25223266/Enhanced_and_persistent_antibody_response_against_homologous_and_heterologous_strains_elicited_by_a_MF59_adjuvanted_influenza_vaccine_in_infants_and_young_children_ DB - PRIME DP - Unbound Medicine ER -