한국 영아에서 eIPV의 면역원성과 안정성 = Immunogenicity and safety of enhanced-inactivatedpoliovaccine(eIPV) in healthy Korean infants

다국어 초록 (Multilingual Abstract)

Purpose:We evaluated the immunogenicity and safety of eIPV(Imovax PolioⓇ) in a group of healthy Korean infants on a three-dose primary vaccination.
Methods:Eighty one healthy infants aged 8-10 weeks were enrolled, and 79(male 42, female 37) completed the study. Three doses of eIPV were injected intramuscularly at 2, 4 and 6 months of age as of primary vaccination. Most subjects received concomitant vaccines such as DTaP and/or Hib at 2, 4, and 6 months of age. Immediate reactions were monitored for 30 minutes after each injection. Local and systemic events were recorded for 72 hours following each immunization by parents/ guardians. Poliovirus specific neutralizing antibodies were measured using enzyme immuno-assay (EIA) at prior to and 1 month after the third dose. An antibody titer of 1:8 or higher was considered seroprotective. Geometric mean titers(GMTs) to each poliovirus type antigen were also measured.
Results:One month after the third dose of eIPV, all infants(100 percent) were seroprotective. The geometric mean titers(GMTs) were 1,532(95 percent CI:1,312-1,788) in type 1 and 835(95 percent CI:684-1,018) in type 2 and 846(95 percent CI:692-1,035) in type 3. Overall, local reactions were observed in 10 percent of infants and systemic reactions in 26.2 percent of infants. All reactions were observed within 3 days after vaccination and resolved without treatment.
Conclusion:eIPV(Imovax PolioⓇ) is a well-tolerated and highly immunogenic vaccine. It can be administered either alone or simultaneously with other routine vaccines to Korean infants.

국문 초록 (Abstract)

목 적 : 폴리오 백신은 OPV와 IPV가 있으며 모두 탁월한 예방효과를 보여 이제는 지구상에서의 폴리오 근절을 기대하게 되었다. 그러나 OPV 백신바이러스의 유전자 변형과 이로 인한 마비환자 발생이 알려지면서 폴리오 근절을 위해서는 반드시 OPV를 중단하고 IPV를 사용하게 되었다. 우리나라에서도 2002년 이후 새로운 eIPV 사용이 추천되었으며 2005년말 부터는 eIPV만을 사용하고 있다. 본 연구는 최근 국내에 도입된 eIPV의 면역원성과 안정성을 확인 하고자 하였다. 방 법 : 생후 2개월 된 건강한 영아 81명을 대상으로 폴리오 백신을 2개월 간격으로 3회 접종한 후 혈청 내 중화항체가를 측정하였다. 폴리오 백신은 Imvax Polio (Aventis Pasteur, Lyon, France)로 단독 또는 DTaP와 B형 간염 또는 Hib 백신을 동시에 접종하였다. 면역원성은 접종 전 및 3회 접종 1개월 후에 혈청 내 중화항체가를 측정하였다. eIPV의 안전성은 접종 후 30분 동안 병원에서 조기 이상반응을 관찰하였으며 접종 후 3일간은 보호자에 의해 국소 및 전신 반응을 관찰하였다.결 과 : 81명 중 79명이 성공적으로 연구를 마쳤다. eIPV 접종 전 및 3회 접종 후 혈청 내 중화 항체가(GMT)는 폴리오바이러스 1형은 접종 전 4.1에서 접종 후 1,531로 증가하였으며, 2형은 접종 전 7.7에서 접종 후 834로 증가하였고, 3형은 접종 전 3.3 에서 접종 후 846으로 증가하였다. 3회 접종 후 중화 항체가의 양전율은 1, 2, 3형 모두 100%를 보였다. 이상 반응으로는 발적(3.4%) 동통(2.5%) 등의 국소반응과 보챔(9.7%), 기면(5.5 %), 식욕부진(4.6%), 발열(4.2%) 등의 전신반응이 있었으며 모두 해열제 사용 등 간단한 처치로 회복되었다.

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