国产无硫柳汞三价流感病毒裂解疫苗上市后免疫原性和安全性观察Immunogenicity and safety of a licensed Chinese thimerosal-free trivalent split influenza virus vaccine
杨北方,邓鹏,郭雪,郑念祥,李琼,钱小爱,王兆,黄菊芬,陈海平,石煊雯,马燕丽,姜葳,占发先,叶建君,刘小琴
摘要(Abstract)：
目的评价一种无硫柳汞的国产三价流感病毒裂解疫苗(TIV)上市后免疫原性和安全性。方法采用单中心、无对照设计在湖北省某乡镇招募≥6月龄健康受试者,接种本研究TIV,检测受试者免疫前和全程免疫后21-28d血清H1N1、H3N2、B型流感病毒血凝抑制(HI)抗体,观察接种后7d内不良反应。结果 591名受试者TIV免疫后H1N1、H3N2、B型流感病毒HI抗体阳转率分别为73.3%、86.3%、65.8%,抗体几何平均滴度(GMT)分别比免疫前增长10.9倍、20.2倍、8.0倍,抗体保护率分别为97.5%、100%、96.6%。720名受试者接种疫苗后总不良反应发生率为4.4%,其中局部反应、全身反应分别为0.8%、3.6%,未发现严重不良反应。结论本研究TIV应用于≥6月龄人群的免疫原性和安全性良好。
关键词(KeyWords)： 三价流感病毒裂解疫苗;免疫原性;安全性
基金项目(Foundation): 湖北省医学领军人才培养工程专项经费资助项目;; 疫苗临床评价技术平台建设(2018ZX09734004)
作者(Author): 杨北方,邓鹏,郭雪,郑念祥,李琼,钱小爱,王兆,黄菊芬,陈海平,石煊雯,马燕丽,姜葳,占发先,叶建君,刘小琴
参考文献(References)：
- [1] World Health Organization. Vaccines against influenza WHO position paper-November 2012[J]. Weekly Epidemiological Record, 2012, 87(47):461-476.
- [2] World Health Organization. Up to 650 000 people die of respiratory diseases linked to seasonal flueach year[EB/OL].(2017-12-14)[2018-10-17]. http://www.who.int/en/news-room/fact-sheets/detail/inf luenza-(seasonal).
- [3]赵大鹏,姚为民,谷丽娟,等.不含硫柳汞流感病毒裂解疫苗的稳定性[J].中国生物制品学杂志, 2015, 28(4):334-338.ZHAO Dapeng, YAO Weiming, GU Lijuan, et al. Stability of thimerosal-free influenza virus split vaccine[J].Chinese Journal of Biologicals, 2015, 28(4):334-338.
- [4]戴宗祥,高菁霞,马磊,等.儿童剂量不含硫柳汞的流感病毒裂解疫苗的制备及其稳定性研究[J].国际检验医学杂志,2014, 35(9):1100-1102.DAI Zongxiang, GAO Jingxia, MA Lei, et al. Research on preparation of inf luenza virus vaccine without thimerosal for children dose and its stability[J]. International Journal of Laboratory Medicine, 2014, 35(9):1100-1102.
- [5]何鹏,梁争论.硫柳汞防腐剂在人用疫苗中的应用[J].中国生物制品学杂志, 2013, 26(1):135-138+143.HE Peng, LIANG Zhenglun. Application of thimerosal as a preservative to vaccines for human use[J]. Chinese Journal of Biologicals, 2013, 26(1):135-138+143.
- [6]朱昌林,方捍华,朱凤才,等.流行性感冒病毒裂解疫苗的安全性和免疫原性研究[J].中华实验和临床病毒学杂志,2004, 18(3):207-209.ZHU Changlin, FANG Hanhua, ZHU Fengcai, et al.Safety and immunogenicity of split vaccines of influenza viruses[J]. Chinese Journal of Experimental and Clinical Virology, 2004, 18(3):207-209.
- [7]张雪梅,戚凤春,汪春义,等.流行性感冒病毒裂解疫苗安全性与免疫原性研究[J].中国疫苗和免疫, 2009, 15(3):229-232.ZHANG Xuemei, QI Fengchun, WANG Chunyi, et al.Evaluation on the safety and immunogenicity of split influenza virus vaccine[J]. Chinese Journal of Vaccines and Immunization, 2009, 15(3):229-232.
- [8]吴金妍,柴文清,储艳,等.流感病毒裂解疫苗接种人体后的安全性和免疫原性观察[J].中国生物制品学杂志, 2015,28(11):1173-1176.WU Jingyan, CHAI Wenqing, CHU Yan, et al. Safety and immunogenicity of inf luenza vaccine(split virion)in humans[J]. Chinese Journal of Biologicals, 2015, 28(11):1173-1176.
- [9]黄清霄,郭强,周宏超.国产流感病毒裂解疫苗的免疫原性及安全性效果评价[J].中华疾病控制杂志, 2010, 14(4):324-326.HUANG Qingxiao, GUO Qiang, ZHOU Hongchao. An evaluation on safety and immunogenicity of domestic trivalent split inf luenza vaccine[J]. Chinese Journal of Disease Control&Prevention, 2010, 14(4):324-326.
- [10]赵艳伟.国产流感裂解疫苗上市后安全性和免疫原性研究[D].北京:中国疾病预防控制中心, 2009.ZHAO Yanwei. Post-marketing evaluation on the safety and immunogenicity of domestic split influenza virus vaccine[D]. Beijing:Chinese Center for Disease Control and Prevention, 2009.
- [11]尤爱国,夏胜利,陈豪敏,等.国产流行性感冒病毒裂解疫苗上市后的安全性及免疫原性评价[J].河南预防医学杂志,2014, 25(1):1-3+15.YOU Aiguo, XIA Shengli, CHEN Haomin, et al. Postmarketing evaluation on the safety and immunogenicity of domestic split influenza virus vaccine[J]. Henan Journal of Preventive Medicine, 2014, 25(1):1-3+15.
- [12] Commission of the European Communities. Harmonization of requirements for influenza vaccine[S]. EEC documentⅢ/3/88/91-EN.