联合疫苗应用现状及评价*

中国生物工程杂志

2009, Vol. 29

Issue (11): 89-93

综述

联合疫苗应用现状及评价*

任军,李建民,陈薇^**

军事医学科学院微生物流行病研究所病原微生物生物安全国家重点实验室北京 100071

Application Status and Evaluation of Combination Vaccines

REN Jun,LI Jian-min,CHEN Wei

Beijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogens and Biosecurity, Beijing 100071, China

全文: PDF(436 KB) HTML

摘要：

联合疫苗含有两种或多种免疫原（活的、灭活的病原体或者提纯的抗原），用于预防多种疾病或由同一病原体的不同亚型或血清型引起的疾病，可以避免常规免疫多次注射的问题。然而和单价疫苗相比，联合疫苗研发的复杂性大大增加，将多种免疫原混合到一起进行免疫时不同免疫原间可能因为物理、化学和免疫学机制而干扰其他免疫原的免疫反应，此外佐剂和防腐剂等非活性成分也可能对联合后的活性成分产生影响，这就对联合疫苗的评价提出了特别的要求。本文对联合疫苗的研究应用现状、临床评价和发展前景等方面做一综述。

关键词： 联合疫苗; 有效性; 安全性

Abstract:

A combination vaccine which consists of ≥2 immunogens is intended to provide protection against two or more diseases or against multiple serotypes of a single disease. The use of combination vaccines decrease the number of vaccine injections in the regular immunization schedules. However，the development of combination vaccines is more complicated than monovalent vaccines, preservatives and adjuvants used with one component may alter the potency of other components. Physical, chemical, and biological interactions between the components of combination vaccines must be considered to avoid detrimental effects on safety or efficacy. Therefore combination vaccines present unique challenges for product evaluation. This paper presents a review of research application status, the evaluation of effectiveness and safety, as well as development prospects on combination vaccines.

Key words: Combination vaccines Efficacy Safety

收稿日期: 2009-02-27 出版日期: 2009-12-07

ZTFLH:

R186

基金资助:

国家“863”计划重大专项资助项目（2006AA02A232）

通讯作者: 陈薇 E-mail: chenwei0226@yahoo.com.cn

	服务
	把本文推荐给朋友
	加入引用管理器
	E-mail Alert
	RSS
	作者相关文章
	任军
	李建民
	陈薇

引用本文:

任军李建民陈薇. 联合疫苗应用现状及评价*[J]. 中国生物工程杂志, 2009, 29(11): 89-93.

LIN Jun, LI Jian-Min, CHEN Wei. Application Status and Evaluation of Combination Vaccines. China Biotechnology, 2009, 29(11): 89-93.

链接本文:

https://manu60.magtech.com.cn/biotech/CN/ 或 https://manu60.magtech.com.cn/biotech/CN/Y2009/V29/I11/89

［1］	Ryman T K, Dietz V, Cairns K L. Too little but not too late: results of a literature review to improve routine immunization programs in developing countries. BMC Health Serv Res. 2008, 8:134
［2］	Murphy T V, Slade B A, Broder K R, et al. Prevention of pertussis, tetanus, and diphtheria among pregnant and postpartum women and their infants recommendations of the Advisory Committee on Immunization Practices (ACIP) . MMWR Recomm Rep, 2008, 57(RR4):1～51
［3］	Mallet E, Belohradsky B H, Lagos R, et al. A liquid hexavalent combined vaccine against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type B and hepatitis B: review of immunogenicity and safety. Vaccine, 2004, 22 (1112):1343～1357
［4］	Centers for Disease Control and Prevention (CDC). Licensure of a diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, and haemophilus B conjugate vaccine and guidance for use in infants and children. MMWR Morb Mortal Wkly Rep, 2008, 57(39):1079，1080
［5］	刘大卫,郭飚,曹玲生,等. 吸附无细胞和全细胞百白破联合疫苗上市后预防接种安全性的比较分析.中国疫苗和免疫,2008,14(2):97～102 Liu D W, Guo B, Cao L S, et al. Chinese Journal of Vaccines and Immunization, 2008, 14(2):97～102
［6］	Stokes J J, Weibel R E, Villarejos V M, et al.Trivalent combined measlesmumpsrubella vaccine. Findings in clinicallaboratory studies. JAMA, 1971, 218(1):57～61
［7］	Gillet Y, Steri G C, Behre U, et al. Immunogenicity and safety of measlesmumpsrubellavaricella (MMRV) vaccine followed by one dose of varicella vaccine in children aged 15 months2 years or 2~6 years primed with measlesmumpsrubella (MMR) vaccine. Vaccine, 2009, 27(3):446～453
［8］	何奔, 林云, 王金荣, 等. 国产麻疹、流行性腮腺炎、风疹疫苗免疫效果观察. 实用预防医学, 2008, 15(4):1111~1112 He B, Lin Y, Wang J R, et al. Practical Preventive Medicine, 2008, 15(4):1111，1112
［9］	Beran J. Ten year’s experience with combined hepatitis A and B vaccine . Klin Mikrobiol Infekc Lek, 2008, 14(1):13，14, 16～23
［10］	Joines R W, Blatter M, Abraham B, et al. A prospective, randomized, comparative US trial of a combination hepatitis A and B vaccine (Twinrix) with corresponding monovalent vaccines (Havrix and EngerixB) in adults. Vaccine, 2001, 19(32): 4710～4719
［11］	万宗举, 张华远, 梁争论, 等. 倍尔来福TM甲乙型肝炎联合疫苗在成人中应用的安全性和免疫原性研究. 中国计划免疫,2004,10(3):129～132 Wan Z J，Zhang H Y, Liang Z L, et al. The Chinese Journal of Vaccines and Immunization, 2004, 10(3):129～132
［12］	Griffin K, Bedford R, Townson K, et al. Protective efficacy of a recombinant plague vaccine when coadministered with another subunit or live attenuated vaccine .FEMS Immunol Med Microbiol, 2005,43(3): 425～430
［13］	Morefield G L, Tammariello R F, Purcell B K, et al. An alternative approach to combination vaccines: intradermal administration of isolated components for control of anthrax, botulism, plague and staphylococcal toxic shock. J Immune Based Ther Vaccines, 2008, 6:5
［14］	Elliman D, Bedford H. Safety and efficacy of combination vaccines . BMJ, 2003, 326(7397):995，996
［15］	Wakefield A J, Murch S H, Anthony A, et al. Ileallymphoidnodular hyperplasia, nonspecific colitis, and pervasive developmental disorder in children. Lancet, 1998, 351(9103): 637～641
［16］	Hornig M, Briese T, Buie T, et al. Lack of association between measles virus vaccine and autism with enteropathy: a casecontrol study. PLoS ONE, 2008, 3(9):e3140
［17］	Mikaeloff Y, Caridade G, Rossier M, et al. Hepatitis B vaccination and the risk of childhoodonset multiple sclerosis. Arch Pediatr Adolesc Med, 2007, 161(12):1176～1182
［18］	Offit P A, Quarles J, Gerber M A, et al. Addressing parents’ concerns: do multiple vaccines overwhelm or weaken the infant’s immune system. Pediatrics, 2002, 109(1):124～129
［19］	Taffs R E. Potency tests of combination vaccines. Clin Infect Dis. 2001, 33(4):S362～S366
［20］	Guerra F A, Blatter M M, Greenberg D P, et al. Safety and immunogenicity of a pentavalent vaccine compared with separate administration of licensed equivalent vaccines in US infants and toddlers and persistence of antibodies before a preschool booster dose: a randomized, clinical trial. Pediatrics, 2009, 123(1):301～312
［21］	Cuervo M L, Sterling A L, Nicot I A, et al. Validation of a new alternative for determining in vitro potency in vaccines containing Hepatitis B from two different manufacturers . Biologicals, 2008, 36(6): 375～382
［22］	Story C M, Papa E, Hu C C, et al. Profiling antibody responses by multiparametric analysis of primary B cells. Proc Natl Acad Sci USA, 2008, 105(46):17902~17907

[1]	张登央, 张英, 张丽君, 王妍. 3D技术制备骨修复生物材料的功能和安全性评价[J]. 中国生物工程杂志, 2015, 35(7): 55-61.
[2]	马步云, 何婉婉, 周立, 王毅刚. 癌症靶向基因-病毒ZD55-XAF1抗肝癌移植瘤的生长及其安全性研究[J]. 中国生物工程杂志, 2014, 34(1): 15-20.
[3]	孙彩霞, 汪莹, 吴晓菲, 陈利军, 武志杰. 转基因抗虫棉棉籽组分的代谢组学研究[J]. 中国生物工程杂志, 2012, 32(11): 35-41.
[4]	孙彩霞, 汪莹, 吴晓菲, 陈利军, 武志杰. 转基因抗虫棉棉籽组分的代谢组学研究[J]. 中国生物工程杂志, 2012, 32(11): 35-41.
[5]	余乾, 赵二虎, 曹礼静, 赵谦, 赵永聚. 转基因动物及其产品的安全评估方法研究进展[J]. 中国生物工程杂志, 2012, 32(10): 106-111.
[6]	曹海鹏, 卫若鹏, 何珊, 吕利群. 水产养殖用解淀粉芽孢杆菌微胶囊的安全性评价[J]. 中国生物工程杂志, 2012, 32(05): 58-65.
[7]	刘魁,郭磊,黄晶晶,杨柯. AZ31B镁合金植入小鼠的生物相容性考察[J]. 中国生物工程杂志, 2008, 28(3): 59-63.
[8]	徐凤萍,杨君,冯雪松,安利佳. pRNA:一种安全、稳定、大容量的基因治疗分子载体[J]. 中国生物工程杂志, 2007, 27(6): 96-100.
[9]	林毅. 苏云金杆菌转基因食品的安全性研究[J]. 中国生物工程杂志, 2006, 26(0): 249-251.
[10]	陈英, 黄敏仁, 王明庥. 植物遗传转化新技术和新方法[J]. 中国生物工程杂志, 2005, 25(9): 94-98.
[11]	王利华, 苏乔, 包永明. 转基因植物中载体骨架序列的安全性隐患及解决方案[J]. 中国生物工程杂志, 2004, 24(5): 38-42.
[12]	袁铁铮, 姚斌. 分子水平上益生菌研究进展[J]. 中国生物工程杂志, 2004, 24(10): 27-33.
[13]	张锐, 孙美榕, 张正, 杨捷, 黄燕, 杜慧, 陈绍红. 基因治疗与人类健康[J]. 中国生物工程杂志, 2004, 24(1): 84-90.
[14]	李永春, 孟凡荣. 提高转基因作物生物安全性的分子策略[J]. 中国生物工程杂志, 2003, 23(9): 30-33.
[15]	王紫萱, 易自力. 卡那霉素在植物转基因中的应用及其抗性基因的生物安全性评价[J]. 中国生物工程杂志, 2003, 23(6): 9-13.

Viewed

Full text

Abstract

Cited

Shared

Discussed