甲肝灭活疫苗(Vero细胞)在2岁以上中国健康人群的免疫原性和安全性研究

目的比较甲型肝炎(甲肝)灭活疫苗(Vero细胞)与甲肝灭活疫苗(二倍体细胞)在2岁以上健康人群中的免疫原性和安全性。方法采用随机、盲法、对照的设计,选择2 100名2岁以上甲肝易感者,分为A、B两组,按照0、6月免疫程序,接种甲肝灭活疫苗(Vero细胞)或甲肝灭活疫苗(二倍体细胞)并观察安全性;所有受试者于免前、全程免后1个月采血(前600名还需采集首剂免疫后1个月血样),采用间接酶联免疫吸附试验方法(ELISA)检测抗甲肝病毒抗体(抗-HAV),评价免疫效果。结果 1剂后A组抗-HAV阳转率为96.05%(成人)和92.78%(儿童),B组为94.92%(成人)和96.61%(儿童);2剂后A组为99.61%(成人)和99.53%(儿童),B组为99.41%(成人)和100.00%(儿童)。两组间抗-HAV阳转率均无统计学差异。安全性方面,A组不良反应率为32.41%(成人)和53.61%(儿童),B组为35.56%(成人)和53.33%(儿童),1级反应为主,组间无统计学差异。结论甲肝灭活疫苗(Vero细胞)对2岁以上的人群免疫原性和安全性良好。

Immunogenicity and safety of inactivated hepatitis A vaccines in Chinese healthy population over 2 ;years of age

Objective To evaluate immunogenicity and safety of inactivated hepatitis A vaccine (Vero cell) and hepatitis A vaccine (Diploid cell) in Chinese healthy population over 2 years of age. Methods A randomized , blind, controlled trial involving 2100 healthy subjects over 2 years of age was conducted into group A or B, two dose of hepatitis A vaccine (Vero cell) or hepatitis A vaccine (Diploid cell) were vaccinated with a 6 months interval between doses, and observed for safety. Serum samples before the 1st dose,1 month after 1st dose( only 600 subjects) and 1 month after immunization were collected, tested by ELISA. Results After 1st dose, the seroconversion rates of A group were 96.05%(adults) and 92.78%(children),B group were 94.92%(adults) and 96.61%(children). After two doses, A group were 99.61% (adults) and 99.53% (children) ,B group were 99.41% (adults) and 100.00%(children) .There was no significantly statistical difference between the two groups. The total incidence of adverse reaction of A group were 32.41% (adults) and 53.61% (children) ,which was no significantly statistical difference compared with B group, 35.56% (adults) and 53.33% (children) , and major side effects were mild. Conclusion The immunogenicity of inactivated Hepatitis A Vaccine (Vero cell) was non-inferiority to Hepatitis A Vaccine (Diploid cell),and with the same result in safety.