Ten-Year Antibody Persistence and Booster Response to MenACWY-TT Vaccine After Primary Vaccination at 1-10 Years of Age

Timo Vesikari, Paula Peyrani, Chris Webber, Marie Van Der Wielen, Brigitte Cheuvart, Nathalie De Schrevel, Emmanuel Aris, Mark Cutler, Ping Li, John L Perez, Timo Vesikari, Paula Peyrani, Chris Webber, Marie Van Der Wielen, Brigitte Cheuvart, Nathalie De Schrevel, Emmanuel Aris, Mark Cutler, Ping Li, John L Perez

Abstract

This phase 3B, open-label, extension study (NCT01962207) evaluated long-term persistence of antibodies induced by the quadrivalent meningococcal vaccine conjugated to tetanus toxoid (MenACWY-TT) compared with the meningococcal serogroup C vaccine conjugated to CRM (MenC-CRM) and the quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS) 6 to 10 y after primary vaccination in toddlers (aged 1-<2 y; MenACWY-TT and MenC-CRM) and children (aged 2-<11 y; MenACWY-TT and MenACWY-PS). Antibody responses against meningococcal serogroups A, C, W, and Y were assessed by serum bactericidal antibody assays using rabbit (rSBA) or human (hSBA) complement. A MenACWY-TT booster dose at Year 10 was given to all eligible subjects regardless of the primary vaccine received. At Year 10, the percentages of subjects with rSBA titers ≥1:8 for serogroups A, C, W, and Y were as follows: MenACWY-TT (toddlers), 65.6%, 82.8%, 31.3%, 43.8%, respectively; MenC-CRM, 88.2% for serogroup C; MenACWY-TT (children), 88.9%, 84.1%, 67.1%, 65.9%; and MenACWY-PS, 28.6%, 81.0%, 23.8%, and 23.8%. Corresponding percentages for hSBA titers ≥1:4 were as follows: MenACWY-TT (toddlers), 31.1%, 91.9%, 44.4%, 41.4%; MenC-CRM, 93.8% for serogroup C; MenACWY-TT (children), 34.8%, 91.1%, 61.2%, 72.6%; and MenACWY-PS, 33.3%, 100.0%, 26.3%, and 44.4%. One month after the MenACWY-TT booster, the percentage of subjects with vaccine response ranged from 75.7% to 100.0% across serogroups in all study groups. Postbooster vaccine responses were generally comparable between groups across serogroups. No new safety signals were identified. Antibody responses persisted 10 y after MenACWY-TT vaccination. The MenACWY-TT booster dose was well tolerated and elicited robust immune responses.

Keywords: bactericidal activity; booster; children; conjugate vaccine; persistence; quadrivalent meningococcal vaccine; toddler.

Figures

Figure 1.
Figure 1.
Study design.
Figure 2.
Figure 2.
Subject flow chart.
Figure 3.
Figure 3.
Percentages of subjects with rSBA titers ≥1:8 at 6 to 10 y after primary vaccination with MenACWY-TT, MenC-CRM, or MenACWY-PS (adapted ATP cohort) for (a) serogroup A, (b) serogroup C, (c) serogroup W, and (d) serogroup Y.
Figure 4.
Figure 4.
Percentages of subjects with rSBA titers ≥1:8 at 6 to 10 y after primary vaccination among those who did versus did not receive an extra dose of MenC-CRM; persistence phase (adapted ATP cohort) for (a) serogroup A, (b) serogroup C, (c) serogroup W, and (d) serogroup Y.
Figure 5.
Figure 5.
Percentages of subjects with hSBA titers ≥1:4 at 6 to 10 y after primary vaccination with MenACWY-TT, MenC-CRM, or MenACWY-PS (adapted ATP cohort) (a) serogroup A, (b) serogroup C, (c) serogroup W, and (d) serogroup Y.
Figure 6.
Figure 6.
Reactogenicity events during the 4-d postbooster vaccination phase (booster total vaccinated cohort) in (a) toddlers and (b) children.

References

    1. Cohn AC, MacNeil JR, Clark TA, Ortega-Sanchez IR, Briere EZ, Meer HC, Baker CJ, Messonnier NE.. Prevention and control of meningococcal disease: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2013;62(RR–2):1–28. doi:rr6202a1 [pii].
    1. Centers for Disease Control and Prevention . Chapter 14: meningococcal disease. Public Health Foundation. [accessed 2019 June3] .
    1. European Centre for Disease Prevention and Control . Surveillance Atlas of infectious diseases. [accessed 2019 June3]. .
    1. Cohn AC, MacNeil JR, Harrison LH, Hatcher C, Theodore J, Schmidt M, Pondo T, Arnold KE, Baumbach J, Bennett N, et al. Changes in Neisseria meningitidis disease epidemiology in the United States, 1998-2007: implications for prevention of meningococcal disease. Clin Infect Dis. 2010;50(2):184–91. doi:10.1086/649209.
    1. MacNeil J, Cohn A. Chapter 8: meningococcal disease. Manual for the surveillance of vaccine-preventable diseases. 5th ed. Atlanta (GA): Centers for Disease Control and Prevention; 2017.
    1. Nimenrix® (meningococcal polysaccharide serogroups A, C, W-135 and Y conjugate vaccine) . Summary of product characteristics. Sandwich (Kent, UK): Pfizer Limited; 2019.
    1. Vesikari T, Forsten A, Boutriau D, Bianco V, Van der Wielen M, Miller JM. A randomized study to assess the immunogenicity, antibody persistence and safety of a tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine in children aged 2-10 years. Hum Vaccin Immunother. 2012;8(12):1882–91. doi:10.4161/hv.22165.
    1. Vesikari T, Forsten A, Boutriau D, Bianco V, Van der Wielen M, Miller JM. Randomized trial to assess the immunogenicity, safety and antibody persistence up to three years after a single dose of a tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine in toddlers. Hum Vaccin Immunother. 2012;8(12):1892–903. doi:10.4161/hv.22166.
    1. Vesikari T, Forsten A, Bianco V, Van der Wielen M, Miller JM. Antibody persistence up to 5 years after vaccination of toddlers and children between 12 months and 10 years of age with a quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine. Hum Vaccin Immunother. 2016;12(1):132–39. doi:10.1080/21645515.2015.1058457.
    1. Cohn AC, MacNeil JR, Harrison LH, Lynfield R, Reingold A, Schaffner W, Zell ER, Plikaytis B, Wang X, Messonnier NE, et al. Effectiveness and duration of protection of one dose of a meningococcal conjugate vaccine. Pediatrics. 2017;139(2):e20162193. doi:10.1542/peds.2016-2193.
    1. World Health Organization . Meningococcal vaccines: WHO position paper, November 2011. Wkly Epidemiol Rec. 2011;86(47):521–39.
    1. World Health Organization . WHO expert committee on biological standardization: twenty-seventh report. [accessed 2018 August3]. .
    1. Borrow R, Balmer P, Miller E. Meningococcal surrogates of protection—serum bactericidal antibody activity. Vaccine. 2005;23(17–18):2222–27. doi:10.1016/j.vaccine.2005.01.051.
    1. Findlow J, Balmer P, Borrow R. A review of complement sources used in serum bactericidal assays for evaluating immune responses to meningococcal ACWY conjugate vaccines. Hum Vaccin Immunother. 2019;15(10):2491–500. doi:10.1080/21645515.2019.1593082.
    1. Andrews N, Borrow R, Miller E. Validation of serological correlate of protection for meningococcal C conjugate vaccine by using efficacy estimates from postlicensure surveillance in England. Clin Diagn Lab Immunol. 2003;10(5):780–86. doi:10.1128/CDLI.10.5.780-786.2003.
    1. Campbell H, Andrews N, Borrow R, Trotter C, Miller E. Updated postlicensure surveillance of the meningococcal C conjugate vaccine in England and Wales: effectiveness, validation of serological correlates of protection, and modeling predictions of the duration of herd immunity. Clin Vaccine Immunol. 2010;17(5):840–47. doi:10.1128/CVI.00529-09.
    1. van Ravenhorst MB, van der Klis FRM, van Rooijen DM, Sanders EAM, Berbers GAM. Adolescent meningococcal serogroup A, W and Y immune responses following immunization with quadrivalent meningococcal A, C, W and Y conjugate vaccine: optimal age for vaccination. Vaccine. 2017;35(36):4753–60. doi:10.1016/j.vaccine.2017.06.007.
    1. Ishola DA, Andrews N, Waight P, Yung CF, Southern J, Bai X, Findlow H, Matheson M, England A, Hallis B, et al. Randomized trial to compare the immunogenicity and safety of a CRM or TT conjugated quadrivalent meningococcal vaccine in teenagers who received a CRM or TT conjugated serogroup C vaccine at preschool age. Pediatr Infect Dis J. 2015;34(8):865–74. doi:10.1097/INF.0000000000000750.
    1. Knuf M, Helm K, Kolhe D, Van Der Wielen M, Baine Y. Antibody persistence and booster response 68 months after vaccination at 2-10 years of age with one dose of MenACWY-TT conjugate vaccine. Vaccine. 2018;36(23):3286–95. doi:10.1016/j.vaccine.2018.04.064.
    1. Klein NP, Baine Y, Kolhe D, Baccarini CI, Miller JM, Van der Wielen M. Five-year antibody persistence and booster response after 1 or 2 doses of meningococcal A, C, W and Y tetanus toxoid conjugate vaccine in healthy children. Pediatr Infect Dis J. 2016;35(6):662–72. doi:10.1097/INF.0000000000001123.
    1. Vesikari T, Forsten A, Bianco V, Van der Wielen M, Miller JM. Immunogenicity, safety and antibody persistence of a booster dose of quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine compared with monovalent meningococcal serogroup c vaccine administered four years after primary vaccination using the same vaccines. Pediatr Infect Dis J. 2015;34(12):e298–307. doi:10.1097/INF.0000000000000897.
    1. Baxter R, Baine Y, Kolhe D, Baccarini CI, Miller JM, Van der Wielen M. Five-year antibody persistence and booster response to a single dose of meningococcal A, C, W and Y tetanus toxoid conjugate vaccine in adolescents and young adults: an open, randomized trial. Pediatr Infect Dis J. 2015;34(11):1236–43. doi:10.1097/INF.0000000000000866.
    1. European Centre for Disease Prevention and Control . Disease data from ECDC surveillance atlas for meningococcal disease. [accessed 2019 March20]. .
    1. Quiambao BP, Bavdekar A, Dubey AP, Jain H, Kolhe D, Bianco V, Miller JM, Van der Wielen M. Antibody persistence up to 5 y after vaccination with a quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine in adolescents. Hum Vaccin Immunother. 2017;13(3):636–44. doi:10.1080/21645515.2016.1248009.
    1. Borja-Tabora CF, Montalban C, Memish ZA, Boutriau D, Kolhe D, Miller JM, Van der Wielen M. Long-term immunogenicity and safety after a single dose of the quadrivalent meningococcal serogroups A, C, W, and Y tetanus toxoid conjugate vaccine in adolescents and adults: 5-year follow-up of an open, randomized trial. BMC Infect Dis. 2015;15:409. doi:10.1186/s12879-015-1138-y.
    1. Memish ZA, Goubeaud A, Broker M, Malerczyk C, Shibl AM. Invasive meningococcal disease and travel. J Infect Public Health. 2010;3(4):143–51. doi:10.1016/j.jiph.2010.09.008.

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