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目的观察国产冻干水痘减毒活疫苗在印度的安全性及免疫原性。方法采用单盲、平行、随机(1∶1)、对照的方法,在印度选择104名1~12岁无水痘病史、水痘疫苗接种史及接种禁忌的健康儿童,按照免疫程序,接种国产冻干水痘减毒活疫苗,并以水痘减毒活疫苗Varilrix誖作为对照疫苗,接种疫苗后30 min、0~6 d观察受试者局部和全身反应,采集受试者免疫前及免疫后42~47 d双份静脉血样,分离血清,采用膜抗原荧光抗体(fluorescent antibody to membrane antigen,FAMA)法检测血清中抗水痘-带状疱疹病毒(varicella-zoster virus,VZV)抗体水平,并计算抗体几何平均滴度(GMT)。结果实验组和对照组各52名(100%)受试者全程接种了相应的水痘疫苗,接种疫苗后30 min及0~6 d,均未见严重的局部副反应和全身不良反应,也未见疫苗接种者的密切接触者出现疫苗相关疾病;实验组和对照组免疫后血清抗体阳转率分别为92.31%和80.77%,差异无统计学意义(P>0.05);实验组和对照组免疫后血清抗体GMT分别为58.30和52.40,GMT增长倍数分别为6.21和5.36,两组免疫前及免疫后血清抗体GMT差异无统计学意义(P>0.05)。结论国产冻干水痘减毒活疫苗在印度1~12岁儿童中接种,具有良好的安全性和免疫原性。
Objective To observe the safety and immunogenicity of live attenuated live attenuated varicella vaccine in India. Methods A total of 104 healthy chickenpox patients aged 1-12 years, history of varicella vaccination and contraindications to vaccination were selected in India by single blind, parallel, randomized (1: 1) and control methods. In accordance with the immunization schedule, Varicella attenuated live attenuated varicella vaccine was used as a control vaccine. The local and systemic reactions were observed at 0 to 6 days after vaccination and the subjects were immunized and immunized 42 to 47 d double venous blood samples were collected and the serum was separated. The antibody level of varicella-zoster virus (VZV) in serum was detected by fluorescent antibody to membrane antigen (FAMA) Titer (GMT). Results Fifty-two (100%) subjects in the experimental group and control group were vaccinated with the corresponding varicella vaccine. No severe side effects or systemic adverse reactions were observed 30 min and 0-6 d after vaccination, nor Vaccine-related diseases were found in the close contacts of vaccinees. The positive rates of serum antibody in experimental group and control group after immunization were 92.31% and 80.77%, respectively, with no significant difference (P> 0.05). Immunization of experimental group and control group After the serum GMT was 58.30 and 52.40 respectively, the multiplication of GMT was 6.21 and 5.36, respectively. There was no significant difference in the GMT between the two groups before and after immunization (P> 0.05). Conclusion The live attenuated vaccine of domestic freeze-dried varicella vaccine is inoculated in children aged 1 ~ 12 years in India with good safety and immunogenicity.