Pediatric Infection and Vaccine

The Korean Society of Pediatric Infectious Diseases (대한소아감염학회)
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Immunogenicity, Reactogenicity and Safety of a Combined DTPa-IPV Vaccine Compared with Separate DTPa and IPV Vaccines in Healthy Korean Infants

한국의 건강한 영아를 대상으로 DTPa-IPV 혼합백신을 접종한 경우와 DTPa 백신과 IPV 백신을 각각 투여하였을 경우의 면역원성, 반응원성 및 안전성

  • Kim, Chang Hwi (Department of Pediatrics, Soonchunhyang University Bucheon Hospital) ;
  • Cha, Sung Ho (Department of Pediatrics, Kyunghee University Hospital) ;
  • Shin, Son Moon (Department of Pediatrics, Cheil General Hospital and Women's Healthcare Center Kwandong University College of Medicine) ;
  • Kim, Chun Soo (Department of Pediatrics, Keimyung Dongsan Medical Center Keimyung University) ;
  • Choi, Young Youn (Department of Pediatrics, Chonnam National University Hospital) ;
  • Hong, Young Jin (Department of Pediatrics, Inha University Hospital) ;
  • Chey, Myoung Jae (Department of Pediatrics, Sanggye Paik Hospital) ;
  • Kim, Kwang Nam (Department of Pediatrics, Hangang Sacred Heart Hospital) ;
  • Hur, Jae Kyun (Department of Pediatrics, St. Paul's Hospital) ;
  • Jo, Dae Sun (Department of Pediatrics, Chonbuk National University Hospital) ;
  • Kim, Sung Shin (Department of Pediatrics, Soonchunhyang University Bucheon Hospital) ;
  • Lee, Sang Lak (Department of Pediatrics, Keimyung Dongsan Medical Center Keimyung University) ;
  • Song, Eun Song (Department of Pediatrics, Chonnam National University Hospital) ;
  • Ramakrishnan, Gunasekaran (GlaxoSmithKline Biologicals) ;
  • Ok, Jin Ju (GlaxoSmithKline Biologicals) ;
  • Van Der Meeren, Olivier (GlaxoSmithKline Biologicals) ;
  • Bock, Hans L. (GlaxoSmithKline Biologicals) ;
  • Kim, Jung Soo (Department of Pediatrics, Chonnam National University Hospital)
  • 김창휘 (순천향대학교 부천병원 소아청소년과) ;
  • 차성호 (경희대학교병원 소아청소년과) ;
  • 신손문 (제일병원 소아청소년과) ;
  • 김천수 (계명대학교 동산의료원 소아청소년과) ;
  • 최영륜 (전남대학교병원 소아청소년과) ;
  • 홍영진 (인하대병원소아청소년과) ;
  • 최명재 (인제대학교 상계백병원 소아청소년과) ;
  • 김광남 (한림대학교 한강성심병원 소아청소년과) ;
  • 허재균 (가톨릭대학교 성바오로병원 소아청소년과) ;
  • 조대선 (전북대학교병원 소아청소년과) ;
  • 김성신 (순천향대학교 부천병원 소아청소년과) ;
  • 이상락 (계명대학교 동산의료원 소아청소년과) ;
  • 송은송 (전남대학교병원 소아청소년과) ;
  • ;
  • 옥진주 ;
  • ;
  • ;
  • 김정수 (전북대학교병원 소아청소년과)
  • Received : 2010.06.10
  • Accepted : 2010.11.03
  • Published : 2010.12.25
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Abstract

Purpose : To compare immunogenicity and reactogenicity of a combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine (DTPa-IPV, $Infanrix^{TM}$ IPV, GlaxoSmithKline Biologicals) with co-administration of commercially available DTPa and IPV vaccines at separate injection sites (DTPa+IPV). Methods : A total of 458 infants aged 8-12 weeks were randomized to receive three-ose primary vaccination at 2, 4 and 6 months with DTPa-IPV or DTPa+IPV. Blood samples were collected pre and post vaccination for measurement of immune responses. Reactogenicity was assessed following each dose using diary cards. Results : One month post-dose 3, seroprotection rates for anti-diphtheria, anti-tetanus and anti-poliovirus types 1, 2 and 3 were ${\geq}99.5%$ and vaccine response rates to pertussis antigens were at least 98.6% in both DTPa-IPV and DTPa + IPV groups. Non-inferiority between the groups was demonstrated based on pre-defined statistical criteria. Incidences of both local and systemic symptoms were within the same range across both groups with grade 3 symptoms reported following no more than 4.3% of DTPa-IPV doses and 4.5% of DTPa + IPV doses. Two serious adverse events (both pyrexia) after DTPa-IPV administration were considered vaccine-related. Both infants recovered fully. Conclusion : Combined DTPa-IPV vaccine was immunogenic and well tolerated when used as a three-dose primary vaccination course in Korean infants. DTPa-IPV could be incorporated into the Korean vaccination schedule, reducing the number of injections required to complete primary immunization.

목적 : 디프테리아, 파상풍, 백일해 및 불활화 폴리오 백신인 GlaxoSmithKline Biologicals의 $Infanrix^{TM}$-IPV(DTPa-IPV)를 접종시, 시판되고 있는 DTPa 백신과 IPV 백신을 각각 다른 부위에 동시 접종 했을 때(DTPa+IPV)와의 면역원성과 반응원성을 비교하기 위하여 본 연구를 시행하였다. 방법 : 생후 8-12주의 영아 458명을 무작위 배정하여, 각각 2, 4, 6개월에 DTPa-IPV 혹은 DTPa+IPV를 3회 기초접종 하였다. 면역반응을 확인하기 위하여 백신접종 전과 후에 채혈을 하였다. 반응원성은 각 백신 접종 후 작성된 증상기록카드를 통하여 평가하였다. 결과 : 3차 백신접종 한달 후에, 항-디프테리아, 항-파상풍 그리고 항-폴리오바이러스 type 1, 2, 3에 대한 혈청 방어율(seroprotection rate)은 ${\geq}99.5%$였고, 두군 모두 백일해 항원에 대한 백신 반응률(vaccine res-ponse rates)은 적어도 98.6% 이상이었다. 두 군간의 비 열등성은 사전 정의된 통계적 기준에 따라 보여주었다. 국소증상과 전신증상 발생률은 두 군 모두 비슷하게 보고되었고, grade 3의 증상이 DTPa-IPV 투여군에서 4.3%, DTPa+IPV 투여군에서는 4.5%로 보고되었다. 두 건의 중대한 이상반응(모두 발열)이 DTPa-IPV 투여 후에 보고되었고, 백신과의 연관성이 있는 것으로 간주되었다. 두 명의 영아는 모두 회복되었다. 결론 : DTPa-IPV 혼합백신은 한국의 소아들에게 기초접종으로 3회 투여시 충분한 면역반응을 보였고, 내약성이 우수했다. DTPa-IPV는 한국 예방접종 스케줄에 편입되어, 기초 접종을 완료하기 위한 접종 회수를 줄일 수 있다.

Keywords

References

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