摘要
目的观察无明胶冻干水痘减毒活疫苗接种后的安全性和免疫原性。方法采用随机、双盲、对照的方法,将1 398名1～12岁儿童分为试验组和对照组,分别接种无明胶和含明胶冻干水痘减毒活疫苗,观察接种后的安全性;并对其中733名接种者采用膜抗原荧光抗体(Fluorescent antibody to membrane antigen,FAMA)法检测水痘抗体水平,观察疫苗的免疫原性。结果试验组与对照组接种后全身反应的总发生率分别为11.49%和14.96%,组间比较差异无统计学意义(P>0.05)。全身反应以发热为主,试验组中度发热反应(37.6～39.0℃)的发生率(0.57%)显著低于对照组(1.71%)(P<0.05);试验组(3.02%)与对照组(2.99%)局部反应的发生率差异无统计学意义(P>0.05),主要表现为疼痛、红肿和瘙痒。试验组和对照组接种前的抗体几何平均滴度(GMT)分别为1∶5.83和1∶6.04;接种后的GMT分别为1∶89.15和1∶94.44,抗体阳转率分别为98.91%和98.37%,组间比较差异均无统计学意义(P>0.05)。结论无明胶冻干水痘减毒活疫苗的免疫原性等同于含明胶冻干水痘减毒活疫苗,且能明显降低中度发热反应的发生率。
Objective To observe the safety and immunogenicity of gelatin-free freeze-dried live attenuated varicella vaccine. Methods A random, double-blinded control trial was performed in 1 398 children aged 1 - 12 years. The 1 398 children were randomly divided into trial and control groups, then inoculated with gelatin-flee and gelatin-containing freeze-dried live attenuated varicella vaccines respectively and observed for safety, of whom 733 were determined for varicella antibody levels by fluorescent antibody to membrane antigen （FAMA） method to observed the immunogenicity of vaccine. Results The systemic reaction rates of children in trial and control groups were 11, 49% and 14. 96% respectively, which showed no significant difference （P 〉 0. 05 ）. The systemic reactions were mainly fever. The moderate fever （37. 6 ～ 39. 0℃ ） rate of children in trial group（0, 57% ） was significantly lower than that in control group （1.71%） （P 〈 0. 05 ）. The local reaction rates of children in trial （3.02%） and control （2. 99%） groups showed no significant difference （P 〉 O. 05）. The local reactions were mainly expressed as pain, redness and swelling as itch. The GMTs of varicella antibodies of trial and control groups were 1 ： 5. 83 and 1 ： 6. 04 before immunization, and 1 ： 89. 15 and 1 ： 94. 44 after immunization, respectively. The antibody positive conversion rates of trial and control groups were 98. 91% and 98. 37% respectively, which showed no significant difference （P 〉 0. 05 ）. Conclusion The immunogenicity of gelatin-free freeze-dried live attenuated varicella vaccine was equivalent to that of gelatin-containing vaccine, while the moderate fever rate decreased significantly.
出处
《中国生物制品学杂志》
CAS
CSCD
2011年第11期1336-1338,共3页
Chinese Journal of Biologicals
关键词
明胶
水痘疫苗
安全性
免疫原性
Gelatin
Varicella vaccine
Safety
Immunogenicity
作者简介
通讯作者：白云骅，E-mail：cycdc@163．com
