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국내 11-12세 소아에서 Td 백신 추가접종의 면역원성과 안전성 평가

The immunogenicity and reactogenicity of Td booster vaccination in Korean preadolescents, aged with 11-12 years old

  • 이수영 (가톨릭대학교 의과대학 소아과학교실) ;
  • 곽가영 (가톨릭대학교 의과대학 소아과학교실) ;
  • 목혜린 (가톨릭대학교 의과대학 소아과학교실) ;
  • 김종현 (가톨릭대학교 의과대학 소아과학교실) ;
  • 허재균 (가톨릭대학교 의과대학 소아과학교실) ;
  • 이경일 (가톨릭대학교 의과대학 소아과학교실) ;
  • 박준수 (순천향대학교 의과대학 소아과학교실) ;
  • 마상혁 (창원파티마병원 소아청소년과) ;
  • 김황민 (연세대학교 원주의과대학 소아과학교실) ;
  • 강진한 (가톨릭대학교 의과대학 소아과학교실)
  • Lee, Soo Young (Department of Pediatrics, The Catholic University of Korea) ;
  • Kwak, Ga Young (Department of Pediatrics, The Catholic University of Korea) ;
  • Mok, Hye Rin (Department of Pediatrics, The Catholic University of Korea) ;
  • Kim, Jong Hyun (Department of Pediatrics, The Catholic University of Korea) ;
  • Hur, Jae Kyun (Department of Pediatrics, The Catholic University of Korea) ;
  • Lee, Kyung Il (Department of Pediatrics, The Catholic University of Korea) ;
  • Park, Joon Su (Department of Pediatrics, Soon Cheon Hyang University) ;
  • Ma, Sang Hyuk (Department of Pediatrics, Changwon Fatima Hospital) ;
  • Kim, Hwang Min (Department of Pediatrics, WonJu Yonsei University) ;
  • Kang, Jin Han (Department of Pediatrics, The Catholic University of Korea)
  • 투고 : 2008.10.05
  • 심사 : 2008.10.27
  • 발행 : 2008.11.15

초록

목 적: 11-12세 연령에 Td 백신 1차 추가접종을 하는 방법에 대한 면역원성과 안전성을 평가하기 위해 연구를 계획하였다. 방 법: 2006년 8월부터 2007년 4월까지 연구병원 소아청소년과 외래에 Td 백신 접종을 받기 위해 내원한 11-12세의 소아를 대상으로 하였다. 면역원성을 평가하기 위하여 접종 전 및 접종 4주 후에 혈액을 채취하여 디프테리아 및 파상풍에 대한 항독소 항체가를 측정하였고 이상반응을 평가하기 위해 관찰 일지에 국소 및 전신 이상반응을 기록하였다. 결 과: 총 183명이 연구에 참여하였고 이들의 평균 연령은 $11.40{\pm}0.51$세이었다. Td 백신 접종 전후의 GMC는 디프테리아에 대해서는 10배, 파상풍에 대해서는 26배 이상 증가하였고, 접종 후 디프테리아와 파상풍에 대한 항체 양전율(항체가 ${\geq}0.1IU/mL$ 기준)은 100%이었다. 디프테리아의 접종 전 항체가가 0.1 IU/mL 이상인 피험자는 142명(77.6%)이었고 접종 후 항체가가 1.0 IU/mL 이상인 피험자는 174명(95.1%)이었다. 파상풍의 접종 전 항체가가 0.1 IU/mL 이상인 피험자는 146명(79.8%)이었고 접종 후 항체가가 1.0 IU/mL 이상인 피험자는 181명(98.9%)이었다. 접종 후 국소 이상반응이 73.8%, 전신 이상반응은 37.2%에서 발생하였으나 대부분 3일 이내 소실되었다. 결 론: 매우 높은 면역원성과 심하지 않은 이상반응을 고려할 때, Td 백신의 접종을 11-12세 시행하는 것은 디프테리아와 파상풍에 대한 가장 경제적인 방어 수단이며, 접종 순응도를 효율적으로 높일 수 있는 방법이다.

Purpose : This study was undertaken to evaluate the immunogenicity and reactogenicity of Td booster immunization in early preadolescents of Korea. Methods : Healthy preadolescents, who had been vaccinated with 4 or 5 doses of DTaP vaccines until 6 years old age, were enrolled in this study from August 2006 to April 2007. Diphtheria and tetanus anti-toxoid antibodies in sera were measured by ELISA just before vaccination and 4 weeks after vaccination to evaluate immunogenicity. Local and systemic adverse reactions observed for 4 weeks after vaccination to access reactogenicity. Results : 183 preadolescents were enrolled and mean age was $11.40{\pm}0.51$ years old. All subjects achieved seroprotective diphtheria and tetanus anti-toxoid antibodies (titers ${\geq}0.1IU/mL$) after Td booster vaccination. Among 183 vaccinees, 73.8% showed local adverse reactions and 37.2% systemic adverse reactions. Pain at injection site (66.1%) was the most common local reaction, and the most commonly shown systemic reaction was myalgia (17.5%). The adverse reactions were spontaneously relieved within three days after vaccination. Conclusion : Td vaccine in this study was high immunogenic and showed an acceptable tolerance in Korean preadolescents. Td booster vaccination at 11-12 years old is the most effective method to increase compliance of the vaccination and to decrease the incidence of diphtheria and tetanus.

키워드

과제정보

연구 과제 주관 기관 : Korea Food & Drug Administration (KFDA)

참고문헌

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피인용 문헌

  1. Clinician awareness of tetanus-diphtheria vaccination in trauma patients: a questionnaire study vol.20, pp.None, 2008, https://doi.org/10.1186/1757-7241-20-35