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Meningococcal – Research Paper

Immunogenicity and safety of an investigational quadrivalent meningococcal conjugate vaccine administered as a booster dose in children vaccinated against meningococcal disease 3 years earlier as toddlers: A Phase III, open-label, multi-center study

, , , , , , , , , , & ORCID Icon show all
Pages 1-10 | Received 23 Dec 2020, Accepted 06 Mar 2021, Published online: 04 Jun 2021

References

  • Bosis S, Mayer A, Esposito S. Meningococcal disease in childhood: epidemiology, clinical features and prevention. J Prev Med Hyg. 2015;56:E121–4.
  • Acevedo R, Bai X, Borrow R, Caugant DA, Carlos J, Ceyhan M, Christensen H, Climent Y, De Wals P, Dinleyici EC, et al. The global meningococcal initiative meeting on prevention of meningococcal disease worldwide: epidemiology, surveillance, hypervirulent strains, antibiotic resistance and high-risk populations. Expert Rev Vaccines. 2019;18:15–30. doi:10.1080/14760584.2019.1557520.
  • European Centre for Disease Prevention and Control. Invasive meningococcal disease - annual epidemiological report for 2017. Stockholm, Sweden: ECDC; 2019.
  • Whittaker R, Dias JG, Ramliden M, Ködmön C, Economopoulou A, Beer N, Pastore Celentano L, Kanitz E, Richter L, Mattheus W, et al. The epidemiology of invasive meningococcal disease in EU/EEA countries, 2004–2014. Vaccine. 2017;35:2034–41. doi:10.1016/j.vaccine.2017.03.007.
  • Krone M, Gray S, Abad R, Skoczynska A, Stefanelli P, van der Ende A, Tzanakaki G, Mölling P, João Simões M, Křížová P, et al. Increase of invasive meningococcal serogroup W disease in Europe, 2013 to 2017. Euro Surveill. 2019;24:24. doi:10.2807/1560-7917.ES.2019.24.14.1800245.
  • Jafri RZ, Ali A, Messonnier NE, Tevi-Benissan C, Durrheim D, Eskola J, Fermon F, Klugman KP, Ramsay M, Sow S, et al. Global epidemiology of invasive meningococcal disease. Popul Health Metr. 2013;11:17. doi:10.1186/1478-7954-11-17.
  • Borrow R, Alarcón P, Carlos J, Caugant DA, Christensen H, Debbag R, De Wals P, Echániz-Aviles G, Findlow J, Head C, et al. The global meningococcal initiative: global epidemiology, the impact of vaccines on meningococcal disease and the importance of herd protection. Expert Rev Vaccines. 2017;16:313–28. doi:10.1080/14760584.2017.1258308.
  • Prevention CfDCa. Meningococcal disease. 2020 Aug 10. https://www.cdc.gov/meningococcal/global.html.
  • European Centre for Disease Prevention and Control. Invasive meningococcal disease: annual epidemiological report for 2017. 2019 Dec 5. https://www.ecdc.europa.eu/sites/default/files/documents/AER_for_2017-invasive-meningococcal-disease.pdf.
  • World Health Organization. Meningococcal vaccines: WHO position paper, November 2011. Wkly Epidemiol Rec:No. 47. 2001;86:521–40.
  • Rouphael NG, Stephens DS. Neisseria meningitidis: biology, microbiology, and epidemiology. Methods Mol Biol. 2012;799:1–20.
  • Dretler AW, Rouphael NG, Stephens DS. Progress toward the global control of Neisseria meningitidis: 21st century vaccines, current guidelines, and challenges for future vaccine development. Hum Vaccin Immunother. 2018;14:1146–60. doi:10.1080/21645515.2018.1451810.
  • Pizza M, Bekkat-Berkani R, Rappuoli R. Vaccines against meningococcal diseases. Microorganisms. 2020;8(10):1521. doi:10.3390/microorganisms8101521.
  • Food and Drug Administration. Menactra. 2020 July 6. https://www.fda.gov/files/vaccines,%20blood%20&%20biologics/published/Package-Insert—Menactra.pdf.
  • Food and Drug Administration. Menveo. 2020 July 6. https://www.fda.gov/media/78514/download.
  • European Medicines Agency. Menveo. 2020 Oct 29. https://www.ema.europa.eu/en/medicines/human/EPAR/menveo.
  • Croxtall JD, Dhillon S. Meningococcal quadrivalent (serogroups A, C, W135 and Y) tetanus toxoid conjugate vaccine (Nimenrix™). Drugs. 2012;72:2407–30.
  • Assaf-Casals A, Dbaibo G. Meningococcal quadrivalent tetanus toxoid conjugate vaccine (MenACWY-TT, Nimenrix™): a review of its immunogenicity, safety, co-administration, and antibody persistence. Hum Vaccin Immunother. 2016;12:1825–37. doi:10.1080/21645515.2016.1143157.
  • European Medicines Agency. Nimenrix. 2020 Oct 29. https://www.ema.europa.eu/en/medicines/human/EPAR/nimenrix.
  • Food and Drug Administration. MenQuadfi. 2020.
  • European Medicines Agency. MenQuadfi. 2020 Nov 27. https://www.ema.europa.eu/en/medicines/human/EPAR/menquadfi.
  • Cohn AC, Harrison LH. Meningococcal vaccines: current issues and future strategies. Drugs. 2013;73:1147–55. doi:10.1007/s40265-013-0079-2.
  • Vuocolo S, Balmer P, Gruber WC, Jansen KU, Anderson AS, Perez JL, York LJ. Vaccination strategies for the prevention of meningococcal disease. Hum Vaccin Immunother. 2018;14:1203–15. doi:10.1080/21645515.2018.1451287.
  • Public Health England. Invasive meningococcal disease in England: annual laboratory confirmed reports for epidemiological year 2017 to 2018. 2020 July 27. https://www.gov.uk/government/publications/meningococcal-disease-laboratory-confirmed-cases-in-england-and-wales.
  • Trotter CL, Andrews NJ, Kaczmarski EB, Miller E, Ramsay ME. Effectiveness of meningococcal serogroup C conjugate vaccine 4 years after introduction. Lancet (London, England). 2004;364:365–67. doi:10.1016/S0140-6736(04)16725-1.
  • Larrauri A, Cano R, García M, Mateo S. Impact and effectiveness of meningococcal C conjugate vaccine following its introduction in Spain. Vaccine. 2005;23:4097–100. doi:10.1016/j.vaccine.2005.03.045.
  • Baxter R, Keshavan P, Welsch JA, Han L, Smolenov I. Persistence of the immune response after MenACWY-CRM vaccination and response to a booster dose, in adolescents, children and infants. Hum Vaccin Immunother. 2016;12:1300–10. doi:10.1080/21645515.2015.1136040.
  • Keyserling H, Papa T, Koranyi K, Ryall R, Bassily E, Bybel MJ, Sullivan K, Gilmet G, Reinhardt A. Safety, immunogenicity, and immune memory of a novel meningococcal (Groups A, C, Y, and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MCV-4) in healthy adolescents. Arch Pediatr Adoles Med. 2005;159:907–13. doi:10.1001/archpedi.159.10.907.
  • Vesikari T, Peyrani P, Webber C, Van Der Wielen M, Cheuvart B, De Schrevel N, Aris E, Cutler M, Li P, Perez JL, et al. Ten-year antibody persistence and booster response to MenACWY-TT vaccine after primary vaccination at 1–10 years of age. Hum Vaccin Immunother. 2020;16:1280–91. doi:10.1080/21645515.2020.1746110.
  • Mbaeyi SA, Bozio CH, Duffy J, Rubin LG, Hariri S, Stephens DS, MacNeil JR. Meningococcal vaccination: recommendations of the advisory committee on immunization practices, United States, 2020. Morb Mortal Wkly Rep. 2020;69:1–41.
  • Áñez G, Hedrick J, Simon MW, Christensen S, Jeanfreau R, Yau E, Pan J, Jordanov E, Dhingra MS. Immunogenicity and safety of a booster dose of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adolescents and adults: a Phase III randomized study. Hum Vaccin Immunother.2020;16:1292–98. doi:10.1080/21645515.2020.1733867.
  • Vesikari T, Sandner B, Martinón-Torres F, Muzsay G, van der Vliet D, Bchir S, Neveu D, Jordanov E, Dhingra MS. Safety and immunogenicity of a quadrivalent meningococcal conjugate vaccine (MenACYW-TT) administered in healthy meningococcal vaccine naïve and MenC vaccine primed toddlers (12–23 months). 37th Annual Meeting of the European Society of Pediatric Infectious Diseases (ESPID); 2019; Ljubljana, Slovenia.
  • Vesikari T, Borrow R, Forsten A, Findlow H, Dhingra MS, Jordanov E. Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in healthy toddlers: a phase II randomized study. Hum Vaccin Immunother. 2020;16:1306–12. doi:10.1080/21645515.2020.1733869.
  • Maslanka SE, Gheesling LL, Libutti DE, Donaldson KB, Harakeh HS, Dykes JK, Arhin FF, Devi SJ, Frasch CE, Huang JC, et al. Standardization and a multilaboratory comparison of Neisseria meningitidis serogroup A and C serum bactericidal assays. The Multilaboratory Study Group. Clin Diagn Lab Immunol. 1997;4:156–67. doi:10.1128/CDLI.4.2.156-167.1997.
  • Newcombe RG. Two-sided confidence intervals for the single proportion: comparison of seven methods. Stat Med. 1998;17:857–72. doi:10.1002/(SICI)1097-0258(19980430)17:8<857::AID-SIM777>3.0.CO;2-E.
  • Baxter R, Reisinger K, Block SL, Izu A, Odrljin T, Dull P. Antibody persistence and booster response of a quadrivalent meningococcal conjugate vaccine in adolescents. J Pediatr. 2014;164:1409–15.e4. doi:10.1016/j.jpeds.2014.02.025.
  • Dhillon S, Pace D. Meningococcal quadrivalent tetanus toxoid conjugate vaccine (MenACWY-TT; Nimenrix®): a review. Drugs. 2017;77:1881–96. doi:10.1007/s40265-017-0828-8.
  • Gill CJ, Baxter R, Anemona A, Ciavarro G, Dull P. Persistence of immune responses after a single dose of Novartis meningococcal serogroup A, C, W-135 and Y CRM-197 conjugate vaccine (Menveo(R)) or Menactra(R) among healthy adolescents. Hum Vaccin. 2010;6:881–87. doi:10.4161/hv.6.11.12849.
  • 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:e298–e307.
  • 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;12:132–39. doi:10.1080/21645515.2015.1058457.
  • Klein NP, Block SL, Johnston W, Percell S, Han L, Dull PM, Smolenov I. 1085: Persistence of meningococcal bactericidal antibodies and booster response at 60-months of age in children who received infant or toddler doses of MenACWY-CRM conjugate vaccine. Open Forum Infect Dis. 2014;1:S319–S. doi:10.1093/ofid/ofu052.793.
  • Bröker M, Berti F, Schneider J, Vojtek I. Polysaccharide conjugate vaccine protein carriers as a “neglected valency” – potential and limitations. Vaccine. 2017;35:3286–94. doi:10.1016/j.vaccine.2017.04.078.