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Immunogenicity and safety of MF59-adjuvanted and full-dose unadjuvanted trivalent inactivated influenza vaccines among vaccine-naïve children in a randomized clinical trial in rural Senegal.
Vaccine. 2018 10 15; 36(43):6424-6432.V

Abstract

INTRODUCTION

Effective, programmatically suitable influenza vaccines are needed for low-resource countries.

MATERIALS AND METHODS

This phase II, placebo-controlled, randomized safety and immunogenicity trial (NCT01819155) was conducted in Senegal using the 2012-2013 Northern Hemisphere trivalent influenza vaccine (TIV) formulation. Participants were allocated in a 2:2:1 ratio to receive TIV (full-dose for all age groups), adjuvanted TIV (aTIV), or placebo. Participants were stratified into age groups: 6-11, 12-35, and 36-71 months. All participants were vaccine-naïve and received two doses of study vaccine 4 weeks apart. The two independent primary objectives were to estimate the immunogenicity of TIV and of aTIV as the proportion of children with a hemagglutination inhibition (HI) antibody titer of ≥1:40 to each vaccine strain at 28 days post-dose two. Safety was evaluated by solicited local and systemic reactions, unsolicited adverse events, and serious adverse events.

RESULTS

296 children received TIV, aTIV, or placebo, and 235 were included in the final analysis. After two doses, children aged 6-11, 12-35, and 36-71 months receiving TIV had HI titers ≥1:40 against A/H1N1 (73.1%, 94.1%, and 97.0%), A/H3N2 (96.2%, 100.0%, and 100.0%), and B (80.8%, 97.1%, and 97.0%), respectively. After two doses, 100% children aged 6-11, 12-35, and 36-71 months receiving aTIV had ≥1:40 titers against A/H1N1, A/H3N2, and B. After a single dose, the aTIV response was comparable to or greater than the TIV response for all vaccine strains. TIV and aTIV reactogenicity were similar, except for mild elevation in temperature (37.5-38.4 °C) which occurred more frequently in aTIV than TIV after each vaccine dose. TIV and aTIV had similarly increased pain/tenderness at the injection site compared to placebo.

CONCLUSIONS

Both aTIV and full-dose TIV were well-tolerated and immunogenic in children aged 6-71 months. These vaccines may play a role in programmatically suitable strategies to prevent influenza in low-resource settings.

Authors+Show Affiliations

UMR Vitrome, Institut de Recherche Pour le Développement, Dakar, Senegal. Electronic address: Aldiouma.Diallo@ird.fr.Center for Vaccine Innovation and Access, PATH, Seattle, USA. Electronic address: jvictor@umich.edu.Center for Vaccine Innovation and Access, PATH, Seattle, USA. Electronic address: jfeser@path.org.Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA. Electronic address: jortiz@som.umaryland.edu.Kanesa, LLC, Cambridge, USA.UMR Vitrome, Institut de Recherche Pour le Développement, Dakar, Senegal.Senegal Ministry of Health and Social Welfare, Dakar, Senegal.UMR Vitrome, Institut de Recherche Pour le Développement, Dakar, Senegal.UMR Vitrome, Institut de Recherche Pour le Développement, Dakar, Senegal.UMR Vitrome, Institut de Recherche Pour le Développement, Dakar, Senegal. Electronic address: tofene.ndiaye@ird.fr.UMR Vitrome, Institut de Recherche Pour le Développement, Dakar, Senegal.Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, USA. Electronic address: gmj3@cdc.gov.Division of Global Health Protection, CDC Kenya, Center for Global Health, Centers for Disease Control and Prevention, Nairobi, Kenya; Division of Global Health Protection, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, USA. Electronic address: zux5@cdc.gov.Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA. Electronic address: kneuzil@som.umaryland.edu.

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

30224199

Citation

Diallo, Aldiouma, et al. "Immunogenicity and Safety of MF59-adjuvanted and Full-dose Unadjuvanted Trivalent Inactivated Influenza Vaccines Among Vaccine-naïve Children in a Randomized Clinical Trial in Rural Senegal." Vaccine, vol. 36, no. 43, 2018, pp. 6424-6432.
Diallo A, Victor JC, Feser J, et al. Immunogenicity and safety of MF59-adjuvanted and full-dose unadjuvanted trivalent inactivated influenza vaccines among vaccine-naïve children in a randomized clinical trial in rural Senegal. Vaccine. 2018;36(43):6424-6432.
Diallo, A., Victor, J. C., Feser, J., Ortiz, J. R., Kanesa-Thasan, N., Ndiaye, M., Diarra, B., Cheikh, S., Diene, D., Ndiaye, T., Ndiaye, A., Lafond, K. E., Widdowson, M. A., & Neuzil, K. M. (2018). Immunogenicity and safety of MF59-adjuvanted and full-dose unadjuvanted trivalent inactivated influenza vaccines among vaccine-naïve children in a randomized clinical trial in rural Senegal. Vaccine, 36(43), 6424-6432. https://doi.org/10.1016/j.vaccine.2018.08.032
Diallo A, et al. Immunogenicity and Safety of MF59-adjuvanted and Full-dose Unadjuvanted Trivalent Inactivated Influenza Vaccines Among Vaccine-naïve Children in a Randomized Clinical Trial in Rural Senegal. Vaccine. 2018 10 15;36(43):6424-6432. PubMed PMID: 30224199.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and safety of MF59-adjuvanted and full-dose unadjuvanted trivalent inactivated influenza vaccines among vaccine-naïve children in a randomized clinical trial in rural Senegal. AU - Diallo,Aldiouma, AU - Victor,John C, AU - Feser,Jodi, AU - Ortiz,Justin R, AU - Kanesa-Thasan,Niranjan, AU - Ndiaye,Moussa, AU - Diarra,Bou, AU - Cheikh,Sathie, AU - Diene,Djibril, AU - Ndiaye,Tofene, AU - Ndiaye,Assane, AU - Lafond,Kathryn E, AU - Widdowson,Marc-Alain, AU - Neuzil,Kathleen M, Y1 - 2018/09/14/ PY - 2018/02/02/received PY - 2018/08/10/revised PY - 2018/08/13/accepted PY - 2018/9/19/pubmed PY - 2019/2/15/medline PY - 2018/9/19/entrez KW - Africa KW - Children KW - Immunogenicity KW - Inactivated Influenza vaccine KW - MF59 adjuvant KW - Safety SP - 6424 EP - 6432 JF - Vaccine JO - Vaccine VL - 36 IS - 43 N2 - INTRODUCTION: Effective, programmatically suitable influenza vaccines are needed for low-resource countries. MATERIALS AND METHODS: This phase II, placebo-controlled, randomized safety and immunogenicity trial (NCT01819155) was conducted in Senegal using the 2012-2013 Northern Hemisphere trivalent influenza vaccine (TIV) formulation. Participants were allocated in a 2:2:1 ratio to receive TIV (full-dose for all age groups), adjuvanted TIV (aTIV), or placebo. Participants were stratified into age groups: 6-11, 12-35, and 36-71 months. All participants were vaccine-naïve and received two doses of study vaccine 4 weeks apart. The two independent primary objectives were to estimate the immunogenicity of TIV and of aTIV as the proportion of children with a hemagglutination inhibition (HI) antibody titer of ≥1:40 to each vaccine strain at 28 days post-dose two. Safety was evaluated by solicited local and systemic reactions, unsolicited adverse events, and serious adverse events. RESULTS: 296 children received TIV, aTIV, or placebo, and 235 were included in the final analysis. After two doses, children aged 6-11, 12-35, and 36-71 months receiving TIV had HI titers ≥1:40 against A/H1N1 (73.1%, 94.1%, and 97.0%), A/H3N2 (96.2%, 100.0%, and 100.0%), and B (80.8%, 97.1%, and 97.0%), respectively. After two doses, 100% children aged 6-11, 12-35, and 36-71 months receiving aTIV had ≥1:40 titers against A/H1N1, A/H3N2, and B. After a single dose, the aTIV response was comparable to or greater than the TIV response for all vaccine strains. TIV and aTIV reactogenicity were similar, except for mild elevation in temperature (37.5-38.4 °C) which occurred more frequently in aTIV than TIV after each vaccine dose. TIV and aTIV had similarly increased pain/tenderness at the injection site compared to placebo. CONCLUSIONS: Both aTIV and full-dose TIV were well-tolerated and immunogenic in children aged 6-71 months. These vaccines may play a role in programmatically suitable strategies to prevent influenza in low-resource settings. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/30224199/Immunogenicity_and_safety_of_MF59_adjuvanted_and_full_dose_unadjuvanted_trivalent_inactivated_influenza_vaccines_among_vaccine_naïve_children_in_a_randomized_clinical_trial_in_rural_Senegal_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(18)31158-7 DB - PRIME DP - Unbound Medicine ER -