초록 ▼

◦ H1N1 아형을 이용한 DNA 백신 후보항원 발굴
◦ H5N8 DNA 백신 후보물질 발굴
◦ H5 DNA 백신에 대한 2종의 동형(clade 2.3.4.4-H5N8/H5N6) 및 4종의 이형(clade 1-H5N1, clade 2.2-H5N1, H7N9, H7N6) 바이러스에 대한 중화항체 형성 평가 완료
◦ 치사 H5N8 바이러스에 대한 H5 DNA 백신의 동물 보호 효능 평가 완료
◦ 효력 검증용 DNA 생산 및 품질 평가
◦ 비임상 시료 생산 공정 및 품질 평가법 개발
◦ 배양/정제 공정 확

◦ H1N1 아형을 이용한 DNA 백신 후보항원 발굴
◦ H5N8 DNA 백신 후보물질 발굴
◦ H5 DNA 백신에 대한 2종의 동형(clade 2.3.4.4-H5N8/H5N6) 및 4종의 이형(clade 1-H5N1, clade 2.2-H5N1, H7N9, H7N6) 바이러스에 대한 중화항체 형성 평가 완료
◦ 치사 H5N8 바이러스에 대한 H5 DNA 백신의 동물 보호 효능 평가 완료
◦ 효력 검증용 DNA 생산 및 품질 평가
◦ 비임상 시료 생산 공정 및 품질 평가법 개발
◦ 배양/정제 공정 확립
◦ 품질 평가 시험법 항목 및 기준 선정

(출처 : 보고서 요약서 3p)

Abstract ▼

□ Purpose & Contents
◦ Development of DNA vaccine candidates
- Development of DNA vaccine candidates against new-emerging influenza
- Construction of DNA vaccine candidates against new-emerging influenza
◦ Evaluation of immunogenicity and efficacy of vaccine candidates
- Evaluation

□ Purpose & Contents
◦ Development of DNA vaccine candidates
- Development of DNA vaccine candidates against new-emerging influenza
- Construction of DNA vaccine candidates against new-emerging influenza
◦ Evaluation of immunogenicity and efficacy of vaccine candidates
- Evaluation of antigen-specific humoral and cellular immune responses
- Evaluation of cross-reactive humoral and cellular immune responses
◦ In order to prepare for the pandemics caused by the novel emerging H5N8 and H7N9 influenza viruses, a universal DNA vaccine capable of rapid vaccine production and high efficiency was developed and evaluated the neutralizing antibody formation ability and protective efficacy in animal. In addition, preclinical efficacy assessment data of the universal DNA vaccine will be prepared.
Establishment of a clinical research through production pre-clinical research and development of DNA vaccine for targeting the universal influenza virus.

□ Results
◦ Selection of candidate antigens using an H1N1 subtype
- Construction of DNA vaccine vectors using HA, NP, M1, and M2e antigens
- Construction of universal vaccine candidates based on HA2 domain
- Investigation of an immunomodulatory function of NP
◦ Development of H5N8 DNA vaccine candidates
- Development of a DNA vaccine against H5N8 whose serotype is identical to that of current prevailing serotype in Korea
- Optimization of immune reponses by combination of antigens (HA, NP, and M1) and fusion of a molecular adjuvant (CD40 ligand)
◦ System establishment and characterization of homologous and heterologous viruses for in vitro evaluation of 6 species
◦ Establishment of neutralization antibody evaluation system based on MN assay
◦ Establishment of evaluation system for the evaluation of mouse protection efficacy using three kinds of homologous H5N8 / H7N9 viruses
◦ Establishment of evaluation system for cross protection efficacy evaluation using three kinds of heterologous mouse lethal H5 / H7 viruses
◦ Completed assessment of neutralization antibody formation of H5 DNA vaccine against two homologous viruses (clade 2.3.4.4-H5N8 / H5N6) and four types of heterologous viruses (clade 1-H5N1, clade 2.2-H5N1, H7N9 and H7N6)
◦ Completed evaluation of animal protection efficacy of H5 DNA vaccine against lethal mouse adapted H5N8 virus
◦ Production and quality evaluation of DNA vaccine for validation
◦ Development of non-clinical sample production process and development of quality evaluation method
◦ Establish culture / purification process

□ Expected Contribution
◦ Development of an H5Nx avian influenza vaccine through clinical studies
◦ Establishment of an emergency vaccine platform for pandemic of new-emerging viruses
◦ Studies on universal vaccines with high efficacy and broad reactivity
◦ Development of H5N8 / H7N9 influenza DNA vaccine can be used as a model of vaccine development that can induce high immunogenicity while minimizing antigen amount.
◦ By securing pandemic prevention vaccines, we can minimize the economic impact by enabling the continuation of economic activities by preventing the closure of industrial facilities and public institutions that may occur during the pandemic.
◦ Identify efficacy in animal models and use them to screen the final candidate vaccine
◦ Production process development can applied to non-clinical sample production(cultivation, purification) after deriving final DNA vaccine candidate
◦ Established process can be applied to future license work

(출처 : SUMMARY 5p)

목차 Contents

• 표지 ... 1
• 제출문 ... 2
• 보고서 요약서 ... 3
• 국문 요약문 ... 4
• SUMMARY ... 5
• Contents ... 7
• 목차 ... 7
• 제1장. 연구개발과제의 개요 ... 8
• 1. 연구개발 목적 ... 8
• 2. 연구개발의 필요성 ... 8
• 3. 연구개발 범위 ... 9
• 제2장. 국내외 기술 개발 현황 ... 10
• 제3장. 연구 수행 내용 및 성과 ... 13
• 제4장. 목표 달성도 및 관련 분야 기여도 ... 44
• 제5장. 연구개발성과의 활용계획 ... 45
• 제6장. 연구 과정에서 수집한 해외 과학기술 정보 ... 46
• 제7장. 연구개발성과의 보안등급 ... 47
• 제8장. 국가과학기술종합정보시스템에 등록한 연구시설·장비 현황 ... 47
• 제9장. 연구개발과제 수행에 따른 연구실 등의 안전 조치 이행 실적 ... 48
• 제10장. 연구개발과제의 대표적 연구 실적 ... 49
• 제11장. 기타 사항: 평가 의견에 따른 보완사항 ... 50
• 제12장. 참고 문헌 ... 52
• 끝페이지 ... 54