冻干水痘减毒活疫苗在健康儿童中两剂免疫后的免疫原性及安全性  

Immunogenicity and safety of freeze-dried live attenuated varicella vaccine by a two-dose schedule in healthy children

作　　者：储艳 柴文清 陈丹丹 CHU Yan;CHAI Wen-qing;CHEN Dan-dan(Shanghai Institute of Biological Products Co., Ltd., Shanghai 200052, Chin)

机构地区：[1]上海生物制品研究所有限责任公司,上海200052

出　　处：《中国生物制品学杂志》2018年第5期511-518,共8页Chinese Journal of Biologicals

摘　　要：目的评价冻干水痘减毒活疫苗在健康儿童中两剂免疫后的免疫原性和安全性。方法选择2~7岁曾接种过1剂冻干水痘减毒活疫苗,且与初次免疫间隔1年、3年、5年的健康儿童作为研究对象,接种第2剂冻干水痘减毒活疫苗,于免疫前、接种后1个月及接种后1年采血,分离血清。采用ELISA法检测血清抗体,计算抗体几何平均浓度(GMC)和阳性率;观察接种后的不良反应,统计不良反应率。结果间隔1年组免前阳性率为73.68%,免后1月和免后1年分别升高至98.25%、94.74%;间隔3年组免前阳性率为65.22%,免后1月和免后1年分别升高至98.55%、89.86%;间隔5年组免前阳性率为71.70%,免后1月和免后1年分别升高至100.00%、92.45%。间隔1年组免前GMC为211.27 m Iu/m L,免后1月和免后1年分别升高至201.30、500.15 m Iu/m L;间隔3年组免前GMC为182.28 m Iu/m L,免后1月和免后1年分别升高至1 642.35、365.77 m Iu/m L;间隔5年组免前GMC为288.99 m Iu/m L,免后1月和免后1年分别升高至1 923.73、504.93 m Iu/m L。除间隔5年组免后1年与免前GMC差异无统计学意义外(P>0.05),其他间隔年限免后1月及免后1年与免疫前比较,GMC和阳性率差异均有统计学意义(P<0.05)。共接种431人,发生全身反应74人,不良反应率为17.17%,大多为1级反应;局部反应仅有1例,为一过性局部疼痛。结论冻干水痘减毒活疫苗的两剂免疫策略可明显提高疫苗保护效果,加强免疫后1年保护力约达90%,因此初免后1年进行水痘疫苗加强免疫可能为最优方案。Objective To evaluate the immunogenicity and safety of live attenuated varicella vaccine by a two-dose schedule in healthy children. Methods Healthy children at ages of 2-7 years,who have been inoculated with one dose of varicella vaccine,were inoculated with freeze-dried live attenuated varicella vaccine 1,3 and 5 years after primary immunization respectively. Serum samples were collected before as well as 4 weeks and one year after immunization and determined for antibody by ELISA,based on which the geometric mean concentration（GMC）and positive rate of antibody were calculated. Adverse reactions were observed after immunization,of which the incidence was calculated. Results In the children immunized with two doses of live attenuated varicella vaccine at an interval of one year,the antibody positive rates before,one month and one year after the second immunization were 73. 68%,98. 25% and 94. 74%,while the GMCs were 211. 27,201. 30 and 500. 15 m Iu/m L,respectively. In the children immunized at an interval of3 years,the antibody positive before,one month and one year after the second immunization were 65. 22%,98. 55% and89. 86%,while the GMCs were 182. 28,1 642. 35 and 365. 77 m Iu/m L,respectively. However,in the children immunized at an interval of 5 years,the antibody positive rates before,one month and one year after the second immunization were 71. 70%,100. 00% and 92. 45%,while the GMCs were 288. 99,1 923. 73 and 504. 93 m Iu/m L,respectively. In general,the GMCs and positive rates of antibody one month and one year after the second immunization in children immunized with two doses at various intervals showed significant difference with those before the second immunization（P〈0. 05）. However,in the children immunized with two doses at an interval of 5 years,the GMC of antibody one year after the second immunization showed no significant difference with that before the second immunization（P〉0. 05）. A total of 431 children were immunized,in whom systemic adverse reactions were observed in 74 o

关 键 词：水痘减毒活疫苗 加强免疫 免疫原性 安全性 

分 类 号：R373.12[医药卫生—病原生物学] R392-33[医药卫生—基础医学]