원문정보
초록
영어
Objective: To gather inputs from clinical experts on selecting and prioritizing research topics, to address unmet vaccine safety needs. Methods: A questionnaire containing 15 vaccine safety assessment research proposals was sent to 28 vaccine experts chosen from various domestic medical association boards, and the rationale for each of the proposals was provided by presenting the following information: 1) a brief summary of the clinical safety studies on the vaccine, conducted by the Clinical Immunization Safety Assessment (CISA) project group, supervised by the United States Center for Disease Control (U.S. CDC), and 2) a summary of recently published studies that address vaccine safety issues. The experts were instructed to select and rank 5 topics in the order of preference, and the preference score for each proposed topic was calculated by assigning points on a scale of 1 to 5. Results: All 28 experts responded to the questionnaire, and the following topics were selected according to their calculated preference scores: 1) Human papillomavirus vaccine safety profile in the Korean female adolescents; 2) A signal detection of adverse events following Influenza vaccination: comparison between the US and South Korea; 3) Incidence of anaphylaxis following National Immunization Program vaccines between 2008 and 2017; 4) Safety of quadrivalent influenza vaccines compared to trivalent influenza vaccines; and 5) Pneumococcal vaccine safety profile in the general population. Conclusion: Five research topics addressing vaccine safety were selected, for which well-constructed research protocols need to be promptly developed to address current unmet vaccine safety needs in South Korea.
목차
연구방법
CISA 백신 안전성 연구 현황 조사
최신 4개년도 전체 대상자, 임신부와 자가면역 질환자 대상 국내외 백신 관련 이상반응 연구현황
백신 안전성 평가 임상연구 수행을 위한 우선순위 연구주제 도출
전문가를 대상으로 백신 안전성 평가를 위한 우선순위 연구대상 선정 조사
연구의 윤리적 측면
연구 결과
CISA 백신 안전성 연구 현황 조사
최신 4개년 다빈도 백신 예방접종 후 이상반응 관련 국내외 연구현황
백신 이상반응 안전성 관리를 위한 전문가 대상 우선순위설문조사 결과
설문 조사 결과, 선정된 최종 후보 연구 주제 5개
고찰 및 결론
감사의 말씀
참고문헌