疫苗稳定性研究的考虑要点
摘要
<正>疫苗为生物活性物质,其抗原活性及免疫原性等生物特性易受到保存温度等条件的影响,因此,疫苗的生产、运输和储存均要求冷链保护。实际应用中,在向非洲等国家和偏远地区分发疫苗的最后阶段,较难始终维持冷链,免疫计划的实
引文
[1]WHO.Use of Men Afri Vac(meningitis A vaccine)in a controlled temperature chain(CTC)during campaigns[M].Geneva:World Health Organization,2013.
[2]Guidelines on the stability evaluation of vaccines for use under extended controlled temperature conditions//WHO Expert Committee on Biological Standardization:sixty-sixth report[R].WHO TRS,2015,999:Annex 5.
[3]Chinese Pharmacopoeia Commission.Pharmacopoeia of People′s Repubic of China(VolⅢ)[S].Beijing:China Med Sci Press,2015.(in Chinese)国家药典委员会.中华人民共和国药典(三部)[S].北京:中国医药科技出版社,2015.
[4]NAIK S P,ZADE J K,SABALE R N,et al.Stability of heat stable,live attenuated rotavirus vaccine(ROTASIIL)[J].Vaccine,2017,35(22):2962-2969.
[5]BURFOOT C,YOUNG P A,FINTER N B.The thermal stability of a stabilized 17D yellow fever virus vaccine[J].J Biol Standard,1977,5(3):173-179.
[6]FINTER N B,FERRIS R,KELLY A,et al.Effects of adverse storage on live virus vaccines[J].Dev Biol Stand,1978,41:271-276.
[7]PERRAUT R,GIRAULT G,MOREAU J P.Stability-related studies on 17D yellow fever vaccine[J].Microbes Infect,2000,2(1):33-38.
[8]BRESEE J S,GLASS R I,VITEK C R.Rotavirus vaccine for the prevention of rotavirus gastroenteritis among children:recommendations of the Advisory Committee on Immunization Practices(ACIP)[J].MMWR Recomm Rep,1999,48(RR-2):1-20.
[9]CHIPPAUX A,CHANIOT S,PIAT A,et al.Stability of freezedried tissue culture rabies vaccine for human use//Rabies in the tropics[M].Springer Berlin Heidelberg,1985:322-324.
[10]NICOLAS A J,PATET J,FALQUET J C,et al.Production of inactivated rabies vaccine for human use on WI38 diploid cells.Results of potency tests.Stability of the vaccine in liquid and freeze-dried forms[J].Dev Biol Stand,1978,40(1):17-24.
[11]CLAPP T,MUNKS M W,TRIVEDI R,et al.Freeze-thaw stress of Alhydrogel alone is sufficient to reduce the immunogenicity of a recombinant hepatitis B vaccine containing native antigen[J].Vaccine,2014,32(30):3765-3771.
[12]ZHANG X,WEI M,SUN G,et al.Real-time stability of a hepatitis E vaccine(Hecolin誖)demonstrated with potency assays and multifaceted physicochemical methods[J].Vaccine,2016,34(48):5871-5877.
[13]International Conference on Harmonization(ICH).Validation of analytical procedures:text and methodology Q2(R1)[C/OL].(2005-11-xx)[2017-12-12].http://www.ich.org/products/guidelines/quality/quality-single/article/validation-of-analytical-procedures-text-and-me-thodology.html.,2005.
[14]WHO.Guidelines on stability evaluation of vaccines//WHO Expert Committee on Biological Standardization:fifty-seventh report[R].WHO TRS,2011,962:Annex 3.
[15]ZIPURSKY S,BOUALAM L,CHEIKH D O,et al.Assessing the potency of oral polio vaccine kept outside of the cold chain during a national immunization campaign in Chad[J].Vaccine,2011,29(34):5652-5656.
[16]ZIPURSKY S,DJINGAREY M H,LODJO J C,et al.Benefits of using vaccines out of the cold chain:delivering meningitis A vaccine in a controlled temperature chain during the mass immunization campaign in Benin[J].Vaccine,2014,32(13):1431-1435.
[17]WHO.Controlled temperature chain-strategic roadmap for priority vaccine[M].Geneva:World Health Organization,2017.
[2]Guidelines on the stability evaluation of vaccines for use under extended controlled temperature conditions//WHO Expert Committee on Biological Standardization:sixty-sixth report[R].WHO TRS,2015,999:Annex 5.
[3]Chinese Pharmacopoeia Commission.Pharmacopoeia of People′s Repubic of China(VolⅢ)[S].Beijing:China Med Sci Press,2015.(in Chinese)国家药典委员会.中华人民共和国药典(三部)[S].北京:中国医药科技出版社,2015.
[4]NAIK S P,ZADE J K,SABALE R N,et al.Stability of heat stable,live attenuated rotavirus vaccine(ROTASIIL)[J].Vaccine,2017,35(22):2962-2969.
[5]BURFOOT C,YOUNG P A,FINTER N B.The thermal stability of a stabilized 17D yellow fever virus vaccine[J].J Biol Standard,1977,5(3):173-179.
[6]FINTER N B,FERRIS R,KELLY A,et al.Effects of adverse storage on live virus vaccines[J].Dev Biol Stand,1978,41:271-276.
[7]PERRAUT R,GIRAULT G,MOREAU J P.Stability-related studies on 17D yellow fever vaccine[J].Microbes Infect,2000,2(1):33-38.
[8]BRESEE J S,GLASS R I,VITEK C R.Rotavirus vaccine for the prevention of rotavirus gastroenteritis among children:recommendations of the Advisory Committee on Immunization Practices(ACIP)[J].MMWR Recomm Rep,1999,48(RR-2):1-20.
[9]CHIPPAUX A,CHANIOT S,PIAT A,et al.Stability of freezedried tissue culture rabies vaccine for human use//Rabies in the tropics[M].Springer Berlin Heidelberg,1985:322-324.
[10]NICOLAS A J,PATET J,FALQUET J C,et al.Production of inactivated rabies vaccine for human use on WI38 diploid cells.Results of potency tests.Stability of the vaccine in liquid and freeze-dried forms[J].Dev Biol Stand,1978,40(1):17-24.
[11]CLAPP T,MUNKS M W,TRIVEDI R,et al.Freeze-thaw stress of Alhydrogel alone is sufficient to reduce the immunogenicity of a recombinant hepatitis B vaccine containing native antigen[J].Vaccine,2014,32(30):3765-3771.
[12]ZHANG X,WEI M,SUN G,et al.Real-time stability of a hepatitis E vaccine(Hecolin誖)demonstrated with potency assays and multifaceted physicochemical methods[J].Vaccine,2016,34(48):5871-5877.
[13]International Conference on Harmonization(ICH).Validation of analytical procedures:text and methodology Q2(R1)[C/OL].(2005-11-xx)[2017-12-12].http://www.ich.org/products/guidelines/quality/quality-single/article/validation-of-analytical-procedures-text-and-me-thodology.html.,2005.
[14]WHO.Guidelines on stability evaluation of vaccines//WHO Expert Committee on Biological Standardization:fifty-seventh report[R].WHO TRS,2011,962:Annex 3.
[15]ZIPURSKY S,BOUALAM L,CHEIKH D O,et al.Assessing the potency of oral polio vaccine kept outside of the cold chain during a national immunization campaign in Chad[J].Vaccine,2011,29(34):5652-5656.
[16]ZIPURSKY S,DJINGAREY M H,LODJO J C,et al.Benefits of using vaccines out of the cold chain:delivering meningitis A vaccine in a controlled temperature chain during the mass immunization campaign in Benin[J].Vaccine,2014,32(13):1431-1435.
[17]WHO.Controlled temperature chain-strategic roadmap for priority vaccine[M].Geneva:World Health Organization,2017.