摘要
目的比较国产冻干水痘减毒活疫苗（VarV-FD）加强免疫的免疫原性和安全性，为制定加强免疫策略提供依据。方法选择完成水痘减毒活疫苗（VarV）初次免疫的1084例1～7岁健康儿童分组观察间隔3个月、1年、3年和5年加强免疫后的水痘抗体水平和不良反应。结果共968名（89．30％）受试者纳入分析。受试者VarV初次免疫后间隔3个月、1年、3年、5年水痘抗体阳性率分别为99．35％、93．90％、88．14％和89．05％（X^2=33．80，P〈0．001）；抗体GMT分别为1：30．05、1：11．11、1：7．50和1：8．2l（F=121．75，P〈0．001）。抗体阳性率和GMT随着免疫间隔时间延长呈下降趋势（X^2=29．15，P〈0．001；F=333．94，P=0．003）。间隔3个月、1年、3年、5年加强免疫后，水痘抗体阳转率分别为32．69％、77．00％、92．37％和95．71％（X^2=336．31，P〈0．001），其中间隔3年与5年组之间无显著性差异，其余各组间均有显著性差异；抗体GMT分别为1：49．67、l：86．99、1：114．15和1：138．55（F=58．92，P〈0．001），均显著高于加强免疫前水平，其中间隔3年与5年组之间无显著性差异，其余各组之间均有显著性差异。加强免疫后抗体阳转率和GMT随着免疫间隔时间延长呈上升趋势（X^2=57．26，P〈0．001；F=189．55，P=0．005）。各组加强免疫后不良反应率分别为12．00％、8．22％、5．93％和5．88％（X^2=9．36，P=0．025），未观察到严重不良反应。结论国产VarV-FD在VarV初次免疫后不同间隔时间进行加强免疫均具有良好的免疫原性和安全性，推荐VarV初次免疫后间隔3年加强免疫1剂次。
Objective To assess immunogenicity and safety of a booster dose of Chinese freeze-dried vari- celia attenuated live vaccine （VarV-FD）, and provide evidence for establishing immunization strategies. Methods A total of 1 084 healthy children aged 1-7 years were selected into groups for detecting vari- cella antibody and observing adverse reactions after a VarV-FD booster immunization at 3 months, 1 year, 3 years, and 5 years following VarV primary immunization. Results A total of 968 （89.30%） subjects were able to be included for analyses. Before the booster dose, the positivity rates of varicella antibody among 3-month, 1-year, 3-year and 5-year post-VarV primary immunization groups were 99.35%,93.90%, 88. 14% and 89.05% （X^2 = 33. bU, P 〈 0. 001 ） , respectively, and the geometric mean antibody titers （GMTs） were 1 ： 30.05, 1：11.11, l： 7. 50 and l： 8. 21 （F=121.75,P〈 0. 001 ）, respectively ; antibody positivity and GMT both showed a decreasing trend （X^2 = 29.15, P 〈0.001; F =333.94, P =0.003）. After the booster dose, seroconversion rates of varicella antibody among the four groups were 32.69%, 77.00%, 92.37% and 95.71% （X2 =336.31, P 〈 0. 001 ）, respectively; no significant difference was seen between the 3-year group and the 5-year group, but differences were seen between the other groups. The antibody GMTs among the four groups were 1 ： 49.67, 1 ： 86.99, 1 ： 114. 15 and 1 ： 138.55 （ F = 58.92, P 〈 0. 001 ） , respectively, which was significantly higher than prior to the booster; no significant difference was seen between the 3-year group and the 5-year group, but differences were seen between the other groups. Antibody sero- conversion rates and GMTs following the booster both showed an increasing trend （X2 = 57.26, P 〈 0. 001 ; F = 189.55, P = 0. 005）. The incidence rates of adverse reactions among the four groups were 12.00%, 8.22%, 5.93% and 5.88% （X^2 =9.36, P =0.025）, respectively. No serious adverse events were observed. Conclusions A booster immunization with Chinese VarV-FD at varying intervals following a primary immunization showed good immunogenicity and safety. We recommend a booster dose to be given 3 years after a primary dose.
出处
《中国疫苗和免疫》
北大核心
2016年第4期366-370,共5页
Chinese Journal of Vaccines and Immunization
基金
广东省疫苗安全重点科学研究基地(编号:2012A061300003)
广州市疫苗安全性评价重点实验室建设(编号:2014SY000009)
广东省医学科学技术研究基金项目(编号:A2015038)
关键词
冻干水痘减毒活疫苗
加强免疫
免疫原性
安全性
Varicella Attenuated Live Vaccine
Freeze-dried
Booster Immunization
Immunogenicity
Safety
作者简介
苏家立（1973-），男，广西合浦县人，广东省生物制品与药物研究所主管药师，学士，从事疫苗临床研究工作。电话：020-89020236．E-mail：1261623521@qq．com．
张吉凯。E-mail：junzjk@163．eom．电话：020-86084873．
