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Comparison of Split versus Subunit Seasonal Influenza Vaccine in Korean Children over 3 to under 18 Years of Age

  • Kang, Seah (Department of Pediatrics, Korea University College of Medicine) ;
  • Kim, Dong Ho (Department of Pediatrics, Korea Cancer Center Hospital) ;
  • Eun, Byung Wook (Department of Pediatrics, Eulji General Hospital) ;
  • Kim, Nam Hee (Department of Pediatrics, Inje University Ilsan Paik Hospital) ;
  • Kang, Eun Kyeong (Department of Pediatrics, Dongguk University Ilsan Hospital) ;
  • Lee, Byong Sop (Department of Pediatrics, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Kim, Yun-Kyung (Department of Pediatrics, Korea University College of Medicine)
  • 투고 : 2019.06.20
  • 심사 : 2019.09.17
  • 발행 : 2019.12.25

초록

목적: 본 연구는 국내 소아청소년에서 인플루엔자 분할백신 접종군과 인플루엔자 아단위백신 접종군 간 면역원성 및 안전성을 파악하기 위해 시행하였다. 방법: 2008년 10월부터 12월까지 서울과 경기도 지역의 여섯 개의 병원에 방문한 202명의 건강한 만 36개월에서 18세 미만의 소아청소년을 대상으로 하였으며 이들은 인플루엔자 분할백신 또는 아단위백신을 접종받았다. H1N1, H3N2, 그리고 B형의 인플루엔자 바이러스 항원의 면역원성을 평가하기 위해 접종 후 혈구응집억제 항체가가 1:40 이상인 피험자의 비율, 항체 양전률, 그리고 geometric mean titer를 계산하였다. 모든 접종자들에서 국소 그리고 전신 이상반응을 관찰하였다. 결과: 분할백신 접종군과 아단위백신 접종군에서 H1N1, H3N2, B형 항원에 대하여 항체가가 1:40 이상으로 나타난 피험자의 비율은 유사하였다(95.9%, 94.9%, 96.9% vs. 96.0%, 90.9%, 87.9%). 36개월이상 72개월미만의 소아에서 두접종군간 항체가가 1:40 이상으로 나타난 피험자의 비율은 유사하게 나타났다. 72개월 이상 18세 미만의 소아에서는 H1N1, H3N2, 그리고 B에 대해 항체가가 1:40 이상으로 나타난 피험자의 비율은 모두 높게 나타났으나 (98.4%, 98.4%, 98.4% vs. 97.0%, 95.5%, 91.0%), 항체 양전율은 상대적으로 낮았다 (39.1%, 73.4%, 35.9% vs. 34.3%, 55.2%, 38.8%). 또한 분할백신 접종군에서 아단위백신 접종군에서보다 국소 및 전신 이상반응의 비율이 더 높았으나 두 접종군 모두에서 중대한 이상반응은 나타나지 않았다. 결론: 인플루엔자 분할백신 접종군과 아단위백신 접종군 모두에서 3세 이상 18세 미만의 연령군에서 적절한 면역원성을 보였다. 또한 두 접종군에서 모두 중대한 이상반응은 발생하지 않았다.

Purpose: This study was conducted to compare immunogenicities and reactogenicities of the trivalent inactivated subunit influenza vaccine and split influenza vaccine in Korean children and adolescents. Methods: In total, 202 healthy children aged 36 months to <18 years were enrolled at six hospitals in Korea from October to December 2008. The subjects were vaccinated with either the split or subunit influenza vaccine. The hemagglutinin inhibition antibody titers against the H1N1, H3N2, and B virus strains were measured, and the seroconversion rates, seroprotection rates, and geometric mean titers were calculated. All subjects were observed for local and systemic reactions. Results: Both the split and subunit vaccine groups had similar seroprotection rates against all strains (95.9%, 94.9%, 96.9% vs. 96.0%, 90.9%, and 87.9%). In children aged 36 to <72 months, the seroprotection rates were similar between the two vaccine groups. In children aged 72 months to <18 years, both vaccines showed high seroprotection rates against the H1N1, H3N2, and B strain (98.4%, 98.4%, 98.4% vs. 97.0%, 95.5%, and 91.0%), but showed relatively low seroconversion rates (39.1%, 73.4%, 35.9% vs. 34.3%, 55.2%, and 38.8%). There were more local and systemic reactions in the split vaccine group than in the subunit vaccine group; however, no serious adverse reactions were observed in both groups. Conclusions: Both the split and subunit vaccines showed acceptable immunogenicity in all age groups. There were no serious adverse events with both vaccines.

키워드

참고문헌

  1. Peltola V, Heikkinen T, Ruuskanen O. Clinical courses of croup caused by influenza and parainfluenza viruses. Pediatr Infect Dis J 2002;21:76-8. https://doi.org/10.1097/00006454-200201000-00020
  2. Ryan-Poirier K. Influenza virus infection in children. Adv Pediatr Infect Dis 1995;10:125-56.
  3. Steininger C, Popow-Kraupp T, Laferl H, Seiser A, Godl I, Djamshidian S, et al. Acute encephalopathy associated with influenza A virus infection. Clin Infect Dis 2003;36:567-74. https://doi.org/10.1086/367623
  4. Reichert TA, Sugaya N, Fedson DS, Glezen WP, Simonsen L, Tashiro M. The Japanese experience with vaccinating schoolchildren against influenza. N Engl J Med 2001;344:889-96. https://doi.org/10.1056/NEJM200103223441204
  5. Neuzil KM, Zhu Y, Griffin MR, Edwards KM, Thompson JM, Tollefson SJ, et al. Burden of interpandemic influenza in children younger than 5 years: a 25-year prospective study. J Infect Dis 2002;185:147-52. https://doi.org/10.1086/338363
  6. Glezen WP, Taber LH, Frank AL, Gruber WC, Piedra PA. Influenza virus infections in infants. Pediatr Infect Dis J 1997;16:1065-8. https://doi.org/10.1097/00006454-199711000-00012
  7. Neuzil KM, Wright PF, Mitchel EF Jr, Griffin MR. The burden of influenza illness in children with asthma and other chronic medical conditions. J Pediatr 2000;137:856-64. https://doi.org/10.1067/mpd.2000.110445
  8. Kim YK, Eun BW, Kim NH, Kang EK, Lee BS, Kim DH, et al. Comparison of immunogenicity and reactogenicity of split versus subunit influenza vaccine in Korean children aged 6-35 months. Scand J Infect Dis 2013;45:460-8. https://doi.org/10.3109/00365548.2012.755267
  9. Sauerbrei A, Langenhan T, Brandstadt A, Schmidt-Ott R, Krumbholz A, Girschick H, et al. Prevalence of antibodies against influenza A and B viruses in children in Germany, 2008 to 2010. Euro Surveill 2014;19:20687. https://doi.org/10.2807/1560-7917.ES2014.19.5.20687
  10. Fraaij PL, Heikkinen T. Seasonal influenza: the burden of disease in children. Vaccine 2011;29:7524-8. https://doi.org/10.1016/j.vaccine.2011.08.010
  11. Sauerbrei A, Schmidt-Ott R, Hoyer H, Wutzler P. Seroprevalence of influenza A and B in German infants and adolescents. Med Microbiol Immunol 2009;198:93-101. https://doi.org/10.1007/s00430-009-0108-7
  12. Coudeville L, Bailleux F, Riche B, Megas F, Andre P, Ecochard R. Relationship between haemagglutination-inhibiting antibody titres and clinical protection against influenza: development and application of a bayesian random-effects model. BMC Med Res Methodol 2010;10:18. https://doi.org/10.1186/1471-2288-10-18
  13. Hobson D, Curry RL, Beare AS, Ward-Gardner A. The role of serum haemagglutination-inhibiting antibody in protection against challenge infection with influenza A2 and B viruses. J Hyg (Lond) 1972;70:767-77. https://doi.org/10.1017/S0022172400022610
  14. The European Agency for the Evaluation of Medicinal Products (EMEA); Committee for Proprietary Medicinal Products (CPMP). Note for guidance on harmonisation of requirements for influenza vaccines (CPMP/BWP/214/96). London: EMEA; 1997.
  15. Fiore AE, Shay DK, Haber P, Iskander JK, Uyeki TM, Mootrey G, et al. Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2007. MMWR Recomm Rep 2007;56:1-54.
  16. Neuzil KM, Dupont WD, Wright PF, Edwards KM. Efficacy of inactivated and cold-adapted vaccines against influenza A infection, 1985 to 1990: the pediatric experience. Pediatr Infect Dis J 2001;20:733-40. https://doi.org/10.1097/00006454-200108000-00004
  17. Talbot HK, Nian H, Zhu Y, Chen Q, Williams JV, Griffin MR. Clinical effectiveness of split-virion versus subunit trivalent influenza vaccines in older adults. Clin Infect Dis 2015;60:1170-5. https://doi.org/10.1093/cid/civ019
  18. Kissling E, Valenciano M, Buchholz U, Larrauri A, Cohen JM, Nunes B, et al. Influenza vaccine effectiveness estimates in Europe in a season with three influenza type/subtypes circulating: the I-MOVE multicentre case-control study, influenza season 2012/13. Euro Surveill 2014;19:20701.
  19. Ruf BR, Colberg K, Frick M, Preusche A. Open, randomized study to compare the immunogenicity and reactogenicity of an influenza split vaccine with an MF59-adjuvanted subunit vaccine and a virosome-based subunit vaccine in elderly. Infection 2004;32:191-8. https://doi.org/10.1007/s15010-004-3204-z
  20. Black S, Nicolay U, Vesikari T, Knuf M, Del Giudice G, Della Cioppa G, et al. Hemagglutination inhibition antibody titers as a correlate of protection for inactivated influenza vaccines in children. Pediatr Infect Dis J 2011;30:1081-5. https://doi.org/10.1097/INF.0b013e3182367662
  21. Chaloupka I, Schuler A, Marschall M, Meier-Ewert H. Comparative analysis of six European influenza vaccines. Eur J Clin Microbiol Infect Dis 1996;15:121-7. https://doi.org/10.1007/BF01591484
  22. Zangwill KM, Belshe RB. Safety and efficacy of trivalent inactivated influenza vaccine in young children: a summary for the new era of routine vaccination. Pediatr Infect Dis J 2004;23:189-97. https://doi.org/10.1097/01.inf.0000116292.46143.d6
  23. Baxter R, Jeanfreau R, Block SL, Blatter M, Pichichero M, Jain VK, et al. A phase III evaluation of immunogenicity and safety of two trivalent inactivated seasonal influenza vaccines in US children. Pediatr Infect Dis J 2010;29:924-30. https://doi.org/10.1097/INF.0b013e3181e075be