Clinical and Experimental Pediatrics

The Korean Pediatric Society (대한소아청소년과학회)
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The immunogenicity and safety of three-component DTaP vaccine in Korean infants

우리나라 영아에서 3가 정제 백일해 항원 DTaP 백신의 면역원성 및 안전성

  • Kang, Jin Han (Department of Pediatrics, College of Medicine, The Catholic University of Korea) ;
  • Kim, Jong Hyun (Department of Pediatrics, College of Medicine, The Catholic University of Korea) ;
  • Lee, Jung Hyun (Department of Pediatrics, College of Medicine, The Catholic University of Korea) ;
  • Lee, Soo Young (Department of Pediatrics, College of Medicine, The Catholic University of Korea) ;
  • Hong, Young Jin (Department of Pediatrics, College of Medicine, Inha University) ;
  • Kim, Chang Hwi (Department of Pediatrics, College of Medicine, Sooncheonhyang University)
  • 강진한 (가톨릭대학교 의과대학 소아과학교실) ;
  • 김종현 (가톨릭대학교 의과대학 소아과학교실) ;
  • 이정현 (가톨릭대학교 의과대학 소아과학교실) ;
  • 이수영 (가톨릭대학교 의과대학 소아과학교실) ;
  • 홍영진 (인하대학교 의과대학 소아과학교실) ;
  • 김창휘 (순천향대학교 의과대학 소아과학교실)
  • Received : 2007.03.03
  • Accepted : 2007.03.10
  • Published : 2007.04.15
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Abstract

Purpose : We conducted the study to evaluate the immunogenicity and safety of three component DTaP vaccine ($Infanrix^{(R)}$) in a group of Korean healthy infants on a three-dose primary vaccination. And we compared the immunogenicity of this DTaP vaccine with two component DTaP vaccine which has been widely used in Korea. Methods : We enrolled one hundred fifty one healthy infants aged 8-9 weeks. These infants were vaccinated at age 2, 4 and 6 months of age with three component DTaP vaccine. Solicited adverse events were actively monitored for 72 hours following each vaccination, and all adverse events after each vaccination were observed for three weeks. Anti-diphtheria toxoid Ab., anti-tetanus toxoid Ab., anti-pertussis toxin Ab., anti-filamentous hemagglutinin Ab., and anti-pertactin Ab. were measured using ELISA for assessing immunogenicity of study vaccine in 60 infants. Immunogenicity analysis of two component DTaP vaccine was performed with same methods in 14 infants as control. Results : The seroconversion rates of anti-diphtheria toxoid Ab, anti-tetanus toxoid Ab. anti-filamentous hemagglutinin Ab. were 100% in both group. Seroconversion rate of anti-pertactin Ab in study group was 100%, but the rate in control group was 50%. However, geometric mean concentration of anti-pertussis toxin Ab. was higher in control group. Mild local and systemic reactions were observed within three days after vaccination, and no serious adverse events related study vaccine were happened during study period. Conclusion : Our study results suggest that three component DTaP vaccine ($Infanrix^{(R)}$) is a well-tolerable and high immunogenic vaccine, especially anti-Pertactin Ab. of the study vaccine is very immunogenic. It can be available as routine DTaP vaccination in our infants.

목 적 : 3가 항원 DTaP 백신을 3회 기초 접종 받은 건강한 국내 영아에서 면역원성 및 안전성을 평가하고자 하였다. 방 법 : 2004년 4월부터 2005년 4월까지 5개 연구 참여 대학병원에서 제태기간 32주 이상에서 태어난 건강한 영아에게 생후 2, 4, 6개월에 3가 항원 DTaP 백신($Infanrix^{(R)}$)을 대퇴부 전외측에 접종하여 접종 전 혈청과 3차 접종 1개월 후 혈청에서 디프테리아, 파상풍, PT, FHA, PRN 항원에 대한 항체를 측정하여 면역원성을 평가하였고, 접종 후 3일 내에 발생이 예상되는 국소 및 전신 이상반응을 적극 관찰하였고 3주내에 발생한 모든 이상반응을 관찰하여 안전성 평가를 실시하였다. 한편, 2가 항원 DTaP 백신을 접종 받은 14명을 대조군으로 설정하여 연구군과 동일한 방법으로 면역원성을 평가하여 비교하였다. 결 과 : 60명에서 실시된 연구군의 면역원성 평가에서 디프테리아, 파상풍, FHA, PRN 항원에 대한 항체 양전율은 100%이었고, PT 항원에 대한 항체 양전율은 98.3%이었다. 한편 대조군에서 디프테리아, 파상풍, PT, FHA 항원에 대한 항체 양전율은 100%이었으나 PRN 항원에 대한 항체 양전율은 50%이었다. 147명에서 확인된 이상반응 평가에서 연구 기간동안 연구 백신과 인과관계가 있는 중증 이상반응은 없었고, 3일 내에 특이한 치료 및 처치가 없이 자연 소멸되는 국소 및 전신 이상반응만 관찰되었으며 접종 차수별 이상반응의 증가도 없었다. 결 론 : 이상의 결과를 볼 때에 3가 항원 DTaP 백신($Infanrix^{(R)}$)은 국내 영아 기초 접종에 유효한 백신임을 확인할 수 있었고, 국내에서 가장 많이 사용되고 있는 2가 DTaP 백신에 비해 PRN항원에 대한 항체의 면역원성이 높은 이점이 있음을 확인하였다. 그러나 향후 더욱 많은 대상을 통한 연구가 이루어져 이런 결과를 재입증하여야 할 것이고, 추가 접종에 대한 동일한 연구도 요구된다.

Keywords

Acknowledgement

Supported by : GSK사

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