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Research Paper

A dose ranging study of 2 different formulations of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants

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Pages 549-559 | Received 31 Oct 2018, Accepted 04 Jan 2019, Published online: 15 Feb 2019

References

  • Cherian T. WHO expert consultation on serotype composition of pneumococcal conjugate vaccines for use in resource-poor developing countries, 26-27 October 2006, Geneva. Vaccine. 2007;25:6557–64. doi:10.1016/j.vaccine.2007.06.044.
  • O’Brien K, Wolfson LJ, Watt JP, Henkle E, Deloria-Knoll M, McCall N, Lee E, Mulholland K, Levine OS, Cherian T. Burden of disease caused by Streptococcus pneumoniae in children younger than 5 years: global estimates. Lancet. 2009;374(9693):893–902. doi:10.1016/S0140-6736(09)61204-6.
  • Drijkoningen JJ, Rohde GG. Pneumococcal infection in adults: burden of disease. Clin Microbiol Infect. 2014;20 Supple 5:45–51. doi:10.1111/1469-0691.12461.
  • Arditi M, Mason EO Jr, Bradley JS, Tan TQ, Barson WJ, Schutze GE, Wald ER, Givner LB, Kim KS, Yogev R, et al. Three-year multicenter surveillance of pneumococcal meningitis in children: Clinical characteristics, and outcome related to penicillin susceptibility and dexamethasone use. Pediatrics. 1998;102(5):1087–1097.
  • Pilishvili T, Lexau C, Farley MM, Hadler J, Harrison LH, Bennett NM, Reingold A, Thomas A, Schaffner W, Craig AS, et al. Sustained reductions in invasive pneumococcal disease in the era of conjugate vaccine. J Infect Dis. 2010;201(1):32–41. doi:10.1086/648593.
  • Moore MR, Link-Gelles R, Schaffner W, Lynfield R, Lexau C, Bennett NM, Petit S, Zansky SM, Harrison LH, Reingold A, et al. Effect of use of 13-valent pneumococcal conjugate vaccine in children on invasive pneumococcal disease in children and adults in the USA: analysis of multisite, population-based surveillance. Lancet Infect Dis. 2015;15(3):301–09. doi:10.1016/S1473-3099(14)71081-3.
  • Lepoutre A, Varon E, Georges S, Dorleans F, Janoir C, Gutmann L, Lévy-Bruhl D. Impact of the pneumococcal conjugate vaccines on invasive pneumococcal disease in France, 2001-2012. Vaccine. 2015;33(2):359–66. doi:10.1016/j.vaccine.2014.11.011.
  • Weiss S, Falkenhorst G, van der Linden M, Imohl M, von Kries R. Impact of 10- and 13-valent pneumococcal conjugate vaccines on incidence of invasive pneumococcal disease in children aged under 16 years in Germany, 2009 to 2012. Euro Surveill. 2015;20(10):21057. doi:10.2807/1560-7917.ES2015.20.10.21057.
  • Martinelli D, Pedalino B, Cappelli MG, Caputi G, Sallustio A, Fortunato F, Tafuri S, Cozza V, Germinario C, Chironna M, et al. Towards the 13-valent pneumococcal conjugate universal vaccination: effectiveness in the transition era between PCV7 and PCV13 in Italy, 2010-2013. Hum Vaccin Immunother. 2014;10(1):33–39. doi:10.4161/hv.26650.
  • Waight PA, Andrews NJ, Ladhani SN, Sheppard CL, Slack MP, Miller E. Effect of the 13-valent pneumococcal conjugate vaccine on invasive pneumococcal disease in England and Wales 4 years after its introduction: an observational cohort study. Lancet Infect Dis. 2015;15(5):535–43. doi:10.1016/S1473-3099(15)70044-7.
  • Zhou F, Shefer A, Kong Y, Nuorti JP. Trends in acute otitis media-related health care utilization by privately insured young children in the United States, 1997-2004. Pediatrics. 2008;121(2):253–60. doi:10.1542/peds.2007-0619.
  • Greenberg D, Hoffman S, Leibovitz E, Dagan R. Acute otitis media in children: association with day care centers–antibacterial resistance, treatment, and prevention. Paediatr Drugs. 2008;10(2):75–83. doi:10.2165/00148581-200810020-00002.
  • Ben-Shimol S, Givon-Lavi N, Leibovitz E, Raiz S, Greenberg D, Dagan R. Impact of widespread introduction of pneumococcal conjugate vaccines on pneumococcal and nonpneumococcal otitis media. Clin Infect Dis. 2016;63(5):611–18. doi:10.1093/cid/ciw347.
  • International Vaccine Access Center. Pneumococcal conjugate vaccine (PCV) product assessment [Internet]. Baltimore (MD): Johns Hopkins Bloomberg School of Public Health; 2013. http://www.jhsph.edu/research/centers-and-institutes/ivac/resources/pcv-product-assessment-april-25-2017.pdf.
  • Greenberg D, Hoover PA, Vesikari T, Peltier C, Hurley DC, McFetridge RD, Dallas M, Hartzel J, Marchese RD, Coller BG, et al. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants. Vaccine. 2018;36(45):6883–91. doi:10.1016/j.vaccine.2018.02.113.
  • Poolman JT, Peeters CC, van Den Dobbelsteen GP. The history of pneumococcal conjugate vaccine development: dose selection. Expert Rev Vaccines. 2013;12(12):1379–94. doi:10.1586/14760584.2013.852475.
  • Ahman H, Käyhty H, Lehtonenm H, Leroy O, Eskola J. Streptococcus pneunoniae capsular polysaccharide-diphtheria toxoid conjugate vaccine is immunogenic in early infancy and able to induce immunologic memory. Ped Infect Dis J. 1998;17(3):211–16. doi:10.1097/00006454-199803000-00008.
  • Ahman H, Käyhty H, Vuorela A, Leroy O, Eskola J. Dose dependency of antibody response in infants and children to pneumococcal polysaccharides conjugated to tetanus toxoid. Vaccine. 1999;17:2726–32.
  • Berger R, Just M. Interference between strains in live virus vaccine II: combined vaccination with varicella and measles-mumps-rubella vaccine. J Biol Stand. 1988;16(4):275–79. doi:10.1016/0092-1157(88)90015-7.
  • Shinefield H, Black S, Digilio L, Reisinger K, Blatter M, Gress JO, Brown ML, Eves KA, Klopfer SO, Schödel F, et al. Evaluation of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children. Pediatr Infect Dis J. 2005;24(8):665–69. doi:10.1097/01.inf.0000172902.25009.a1.
  • Shinefield H, Williams WR, Marchant C, Reisinger K, Stewart T, Meissner C, Meissner HC, Guerrero J, Klopfer SO, Xu J, et al. Dose-response study of a quadrivalent measles, mumps, rubella, and varicella vaccine in healthy children. Pediatr Infect Dis J. 2005;24(8):670–75. doi:10.1097/01.inf.0000172901.29621.e9.
  • Luxembourg A, Brown D, Bouchard C, Giuliano AR, Iversen OE, Joura EA, Penny ME, Restrepo JA, Romaguera J, Maansson R, et al. Phase II studies to select the formulation of a multivalent HPV L1 virus-like particle (VLP) vaccine. Hum Vaccin Immunother. 2015;11(6):1313–22. doi:10.1080/21645515.2015.1012010.
  • Jackson LA, Neuzil KM, Nahm MH, Whitney CG, Yu O, Nelson JC, Starkovich PT, Dunstan M, Carste B, Shay DK, et al. Immunogenicity of varying dosages of 7-valent pneumococcal polysaccharide-protein conjugate vaccine in seniors previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Vaccine. 2007;25(20):4029–37. doi:10.1016/j.vaccine.2007.02.062.
  • Lode H, Scmoele-Thoma B, Gruber W, Ahlers N, Fernsten P, Baker S, Razmpour A, Siber G, Hackell J, Lockhart S, et al. Dose-ranging study of a single injection of pneumococcal conjugate vaccine (1x, 2x, or 4x) in healthy subjects aged 70 years or older. Vaccine. 2011;29(31):4940–46. doi:10.1016/j.vaccine.2011.04.132.
  • Sobanjo-Ter Meulen A, Vesikari T, Malacaman EA, Shapiro SA, Dallas MJ, Hoover PA, McFetridge R, Stek JE, Marchese RD, Hartzel J, et al. Safety, tolerability and immunogenicity of 15-valent pneumococcal conjugate vaccine in toddlers previously vaccinated with 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2015;34(2):186–94. doi:10.1097/INF.0000000000000516.
  • McFetridge R, Meulen AS, Folkerth SD, Hoekstra JA, Dallas M, Hoover PA, Marchese RD, Zacholski DM, Watson WJ, Stek JE, et al. Safety, tolerability, and immunogenicity of 15-valent pneumococcal conjugate vaccine in healthy adults. Vaccine. 2015;33(24):2793–99. doi:10.1016/j.vaccine.2015.04.025.
  • Ermlich SJ, Andrews CP, Folkerth S, Rupp R, Greenberg D, McFetridge RD, Hartzel J, Marchese RD, Stek JE, Abeygunawardana C, et al. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults ≥50 years of age. Vaccine. 2018;36(45):6875–82. doi:10.1016/j.vaccine.2018.03.012.
  • Ladhani SN, Collins S, Djennad A, Shepaprd CL, Borrow R, Fry NK, Andrews NJ, Miller E, Ramsay ME. Rapid increase in non-vaccine serotypes causing invasive pneumococcal disease in England and Wales, 2000-17: a prospective national observational cohort study. Lancet Infect Dis. 2018;18:441–51. doi:10.1016/S1473-3099(18)30052-5.
  • Domínguez Á, Ciruela P, Hernández S, García-García JJ, Soldevila N, Izquierdo C, Moraga-Llop F, Díaz AF, de Sevilla M, González-Peris S, et al. Effectiveness of the 13-valent pneumococcal conjugate vaccine in preventing inasive pneumococcal disease in children aged 7-59 months. A matched case-control study. PLoS ONE. 2017;12(8):e0183191. doi:10.1371/journal.pone.0183191.
  • Naucler P, Galanis I, Morfeldt E, Darenberg J, Ortqvist A, Henriques-Normark B. Comparison of the impact of pneumococcal conjugate vaccine 10 or pneumococcal conjugate vaccine 13 on invasive pneumococcal disease in equivalent populations. Clin Infect Dis. 2017;65:1780–90.e1. doi:10.1093/cid/cix685.
  • Sings HL, De Wals P, Gessner BD, Isturiz R, Laferriere C, McLaughlin JM, Pelton S, Schmitt H-J, Suaya JA, Jodar L. Effectiveness of 13-valent pneumococcal conjugate vaccine against invasive disease caused by serotype 3 in children: a systematic review and meta-analysis of observational studies. Clin Infect Dis. 2018 Oct 23. [Epub ahead of print]. doi:10.1093/cid/ciy920.
  • Marchese RD, Puchalski D, Miller P, Antonello J, Hammond O, Green T, Rubinstein LJ, Caulfield MJ, Sikkema D. Optimization and validation of a multiplex, electrochemiluminescence-based detection assay for the quantitation of immunoglobulin G serotype-specific antipneumococcal antibodies in human serum. Clin Vaccine Immunol. 2009;16(3):387–96. doi:10.1128/CVI.00415-08.
  • Burton RL, Nahm MH. Development and validation of a fourfold multiplexed opsonization assay (MOPA4) for pneumococcal antibodies. Clin Vaccine Immunol. 2006;13(9):1004–09. doi:10.1128/CVI.00112-06.
  • Collett D. Statistical inference for binary data. In: Collett D, editor. Modelling binary data. New York (NY): Chapman & Hall; 1991. p. 17–42.
  • Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med. 1985;4:213–26.

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