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Recommendation for use of diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b conjugate, and hepatitis B vaccine in infants

  • Cho, Hye-Kyung (Department of Pediatrics, Gachon University Gil Medical Center, Gachon University College of Medicine) ;
  • Park, Su Eun (Department of Pediatrics, School of Medicine, Pusan National University) ;
  • Kim, Yae-Jean (Department of Pediatrics, Sungkyunkwan University School of Medicine) ;
  • Jo, Dae Sun (Department of Pediatrics, Jeonbuk National University Medical School) ;
  • Kim, Yun-Kyung (Department of Pediatrics, Korea University College of Medicine) ;
  • Eun, Byung-Wook (Department of Pediatrics, School of Medicine, Eulji University) ;
  • Lee, Taek-Jin (Department of Pediatrics, CHA University School of Medicine) ;
  • Lee, Jina (Department of Pediatrics, University of Ulsan College of Medicine) ;
  • Lee, Hyunju (Department of Pediatrics, Seoul National University College of Medicine) ;
  • Kim, Ki Hwan (Department of Pediatrics, College of Medicine, The Catholic University of Korea) ;
  • Cho, Eun Young (Department of Pediatrics, Chungnam National University School of Medicine) ;
  • Ahn, Jong Gyun (Department of Pediatrics, Severance Children's Hospital, Yonsei University College of Medicine) ;
  • Choi, Eun Hwa (Department of Pediatrics, Seoul National University College of Medicine) ;
  • The Committee on Infectious Diseases of the Korean Pediatric Society, (The Korean Pediatric Society)
  • Received : 2021.04.21
  • Accepted : 2021.05.14
  • Published : 2021.12.15

Abstract

In April 2020, the Ministry of Food and Drug Safety licensed a hexavalent combined diphtheria and tetanus toxoids and acellular pertussis (DTaP), inactivated poliovirus (IPV), Haemophilus influenzae type b (Hib) conjugated to tetanus protein, and hepatitis B (HepB) (recombinant DNA) vaccine, DTaP-IPV-Hib-HepB (Hexaxim, Sanofi Pasteur), for use as a 3-dose primary series in infants aged 2, 4, and 6 months. The DTaP-IPV-Hib-HepB vaccine is highly immunogenic and safe and provides a long-term immune response based on studies performed in a variety of settings in many countries, including Korea. This report summarizes the Committee on Infectious Diseases of the Korean Pediatric Society guidelines for the use of this newly introduced hexavalent combination vaccine.

Keywords

References

  1. Halsey NA. Combination vaccines: defining and addressing current safety concerns. Clin Infect Dis 2001;33 Suppl 4:S312-8. https://doi.org/10.1086/322567
  2. Skibinski DA, Baudner BC, Singh M, O'Hagan DT. Combination vaccines. J Glob Infect Dis 2011;3:63-72. https://doi.org/10.4103/0974-777X.77298
  3. Dodd D. Benefits of combination vaccines: effective vaccination on a simplified schedule. Am J Manag Care 2003;9:S6-12.
  4. Koslap-Petraco MB, Parsons T. Communicating the benefits of combination vaccines to parents and health care providers. J Pediatr Health Care 2003;17:53-7. https://doi.org/10.1016/S0891-5245(03)00002-6
  5. Lee SY, Hwang HS, Kim JH, Kim HH, Lee HS, Chung EH, et al. Immunogenicity and safety of a combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus vaccine (DTaP-IPV) compared to separate administration of standalone DTaP and IPV vaccines: a randomized, controlled study in infants in the Republic of Korea. Vaccine 2011;29:1551-7. https://doi.org/10.1016/j.vaccine.2010.12.094
  6. Kang JH, Lee HJ, Kim KH, Oh SH, Cha SH, Lee J, et al. The immunogenicity and safety of a combined DTaP-IPV//Hib vaccine compared with individual DTaP-IPV and Hib (PRP~T) vaccines: a randomized clinical trial in South Korean infants. J Korean Med Sci 2016;31:1383-91. https://doi.org/10.3346/jkms.2016.31.9.1383
  7. Diphtheria, tetanus, pertussis (DTaP, Tdap, Td) vaccine. In: Kim JH, editor. Immunization guideline: 2018 report of the Committee on Infectious Diseases. 9th ed. Seoul (Korea): The Korean Pediatric Society, 2018:89-108.
  8. Ministry of Food and Drug Safety. Full prescribing information-Hexaxim pre-filled syringe [Internet]. Cheongju (Korea): Ministry of Food and Drug Safety; c2020 [cited 2021 Apr 1]. Available from: https://nedrug.mfds.go.kr/pbp/CCBBB01/getItemDetail?itemSeq=202002632.
  9. Obando-Pacheco P, Rivero-Calle I, Gomez-Rial J, Rodriguez-Tenreiro Sanchez C, Martinon-Torres F. New perspectives for hexavalent vaccines. Vaccine 2018;36:5485-94. https://doi.org/10.1016/j.vaccine.2017.06.063
  10. Syed YY. DTaP-IPV-HepB-Hib vaccine (Hexyon(®)): an updated review of its use in primary and booster vaccination. Paediatr Drugs 2019;21:397-408. https://doi.org/10.1007/s40272-019-00353-7
  11. Mukherjee P, Akpo EIH, Kuznetsova A, Knuf M, Silfverdal SA, Kosalaraksa P, et al. Hexavalent vaccines in infants: a systematic literature review and meta-analysis of the solicited local and systemic adverse reactions of two hexavalent vaccines. Expert Rev Vaccines 2021;20:319-30. https://doi.org/10.1080/14760584.2021.1892493
  12. Plotkin SA, Liese J, Madhi SA, Ortiz E. A DTaP-IPV//PRP~T vaccine (Pentaxim): a review of 16 years' clinical experience. Expert Rev Vaccines 2011;10:981-1005. https://doi.org/10.1586/erv.11.72
  13. World Health Organization. WHO - Pre-qualified vaccine [Internet]. Geneva (Switzerland): World Health Organization; c2021 [cited 2021 Apr 1]. Available from: https://extranet.who.int/pqweb/vaccines/prequalified-vaccines.
  14. Kosalaraksa P, Chokephaibulkit K, Benjaponpitak S, Pancharoen C, Chuenkitmongkol S, B'Chir S, et al. Persistence of hepatitis B immune memory until 9-10 years of age following hepatitis B vaccination at birth and DTaP-IPV-HB-PRP~T vaccination at 2, 4 and 6 months. Hum Vaccin Immunother 2018;14:1257-65. https://doi.org/10.1080/21645515.2018.1426418
  15. Vesikari T, Becker T, Vertruyen AF, Poschet K, Flores SA, Pagnoni MF, et al. A phase III randomized, double-blind, clinical trial of an investigational hexavalent vaccine given at two, three, four and twelve months. Pediatr Infect Dis J 2017;36:209-15. https://doi.org/10.1097/INF.0000000000001406
  16. Nunes MC, Madhi SA. Review of a new fully liquid, hexavalent vaccine: Hexaxim. Expert Opin Biol Ther 2013;13:575-93. https://doi.org/10.1517/14712598.2013.774368
  17. Aquino AG, Brito MG, Doniz CE, Herrera JF, Macias M, Zambrano B, et al. A fully liquid DTaP-IPV-Hep B-PRP-T hexavalent vaccine for primary and booster vaccination of healthy Mexican children. Vaccine 2012;30:6492-500. https://doi.org/10.1016/j.vaccine.2012.07.040
  18. Lopez P, Arguedas Mohs A, Abdelnour Vasquez A, Consuelo-Miranda M, Feroldi E, Noriega F, et al. A randomized controlled study of a fully liquid DTaP-IPV-HB-PRP-T hexavalent vaccine for primary and booster vaccinations of healthy infants and toddlers in Latin America. Pediatr Infect Dis J 2017;36:e272-e82. https://doi.org/10.1097/INF.0000000000001682
  19. Kim YK, Vidor E, Kim HM, Shin SM, Lee KY, Cha SH, et al. Immunogenicity and safety of a fully liquid DTaP-IPV-HB-PRP~T hexavalent vaccine compared with the standard of care in infants in the Republic of Korea. Vaccine 2017;35:4022-8. https://doi.org/10.1016/j.vaccine.2017.05.062
  20. Ceyhan M, Yildirim I, Tezer H, Devrim I, Feroldi E. A fully liquid DTaP-IPV-HB-PRP-T hexavalent vaccine for primary and booster vaccination of healthy Turkish infants and toddlers. Turk J Med Sci 2017;47:1247-56. https://doi.org/10.3906/sag-1609-62
  21. European Medicines Agency. Scientific conclusions and grounds for the suspension of the marketing authorisation of Hexavac presented by the EMEA [Internet]. Amsterdam (Denmark): European Medicines Agency; c2005 [cited 2021 Mar 15]. Available from: https://www.ema.europa.eu/en/documents/scientific-conclusion/hexavac-epar-scientific-conclusion_en.pdf.
  22. Jorgensen P, Poethko-Muller C, Hellenbrand W, Jilg W, Thierfelder W, Meyer C, et al. Low hepatitis B immunogenicity of a hexavalent vaccine widely used in Germany: results of the German Health Survey for Children and Adolescents, 2003-2006. Epidemiol Infect 2010;138:1621-9. https://doi.org/10.1017/s0950268810000543
  23. Wenzel JJ, Jilg W. Loss of antibodies, but not of protection. Lancet Infect Dis 2010;10:738-9. https://doi.org/10.1016/S1473-3099(10)70217-6
  24. Poliovirus vaccine. In: Kim JH, editor. Immunization guideline: 2018 report of the Committee on Infectious Diseases. 9th ed. Seoul (Korea): The Korean Pediatric Society, 2018:109-17.
  25. Haemophilus influenzae type b (Hib) vaccine. In: Kim JH, editor. Immunization guideline: 2018 report of the Committee on Infectious Diseases. 9th ed. Seoul (Korea): The Korean Pediatric Society, 2018:118-31.
  26. Hepatitis B vaccine. In: Kim JH, editor. Immunization guideline: 2018 report of the Committee on Infectious Diseases. 9th ed. Seoul (Korea): The Korean Pediatric Society, 2018:76-88.
  27. Oliver SE, Moore KL. Licensure of a diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b conjugate, and hepatitis b vaccine, and guidance for use in infants. Morb Mortal Wkly Rep 2020;69:136-9. https://doi.org/10.15585/mmwr.mm6905a5
  28. Poovorawan Y, Theamboonlers A, Vimolket T, Sinlaparatsamee S, Chaiear K, Siraprapasiri T, et al. Impact of hepatitis B immunisation as part of the EPI. Vaccine 2000;19:943-9. https://doi.org/10.1016/S0264-410X(00)00216-4
  29. Poovorawan Y, Sanpavat S, Pongpunlert W, Chumdermpadetsuk S, Sentrakul P, Chitinand S, et al. Comparison of a recombinant DNA hepatitis B vaccine alone or in combination with hepatitis B immune globulin for the prevention of perinatal acquisition of hepatitis B carriage. Vaccine 1990;8:S56-9; discussion S60-2. https://doi.org/10.1016/0264-410X(90)90221-7
  30. Tharmaphornpilas P, Rasdjarmrearnsook A-o, Plianpanich S, Sanguanmoo P, Poovorawan Y. Increased risk of developing chronic HBV infection in infants born to chronically HBV infected mothers as a result of delayed second dose of hepatitis B vaccination. Vaccine 2009;27:6110-5. https://doi.org/10.1016/j.vaccine.2009.08.034
  31. Chiappini E, Petrolini C, Caffarelli C, Calvani M, Cardinale F, Duse M, et al. Hexavalent vaccines in preterm infants: an update by Italian Society of Pediatric Allergy and Immunology jointly with the Italian Society of Neonatology. Ital J Pediatr 2019;45:145. https://doi.org/10.1186/s13052-019-0742-7
  32. European Medicines Agency. Hexaxim: Product information [Internet]. Amsterdam (Denmark): European Medicines Agency; c2020 [cited 2021 Apr 1]. Available from: https://www.ema.europa.eu/en/documents/medicine-outside-eu/hexaxim-product-information_en.pdf.
  33. World Health Organization. Public assessment summary report-Hexaxim® [Internet]. Geneva (Switzerland): World Health Organization; c2015 [cited 2021 Mar 20]. Available from: https://www.who.int/immunization_standards/vaccine_quality/pq_284_Hexaxim_1dose_SP_Hexaxim_VPSAR.pdf.