CAJ | 학술논문

目的观察采用不含明胶、不含人血白蛋白保护剂制备的冻干甲型肝炎(甲肝)减毒活疫苗接种后的安全性及免疫原性.方法在浙江杭州及河北正定二个点,筛选了183名甲肝病毒易感者,给予冻干甲肝减毒活疫苗一针免疫.观察疫苗接种后7d内的局部和全身反应,同时采集接种后的血清样本,检测甲肝抗体阳转率及抗体产生的水平.结果观察期间主要表现为轻度反应,肝功能检测未见异常,未发生与疫苗有关的重度反应、皮疹及不良事件.疫苗接种后2个月的抗体阳转率为98.2％,抗体的几何平均滴度为135.5 mIU/mL.结论不含明胶、不含人血白蛋白的保护剂制备的疫苗安全性及免疫原性良好.
목적 관찰채용불함명효、불함인혈백단백보호제제비적동간갑형간염(갑간)감독활역묘접충후적안전성급면역원성.방법 재절강항주급하북정정이개점,사선료183명갑간병독역감자,급여동간갑간감독활역묘일침면역.관찰역묘접충후7d내적국부화전신반응,동시채집접충후적혈청양본,검측갑간항체양전솔급항체산생적수평.결과 관찰기간주요표현위경도반응,간공능검측미견이상,미발생여역묘유관적중도반응、피진급불량사건.역묘접충후2개월적항체양전솔위98.2％,항체적궤하평균적도위135.5 mIU/mL.결론 불함명효、불함인혈백단백적보호제제비적역묘안전성급면역원성량호.
Objective To observe the safety and immunogenicity of freeze-dried live attenuated hepatitis A vaccine prepared by a protective additive without gelatin and human albumin.Methods One hundred and eighty-three persons susceptible to hepatitis A virus were screened from 2 sites in Hangzhou,Zhejiang and Zhengding,Hebei.Each person was inoculated by one dose live attenuated hepatitis A vaccine and observed for local and systemic reaction in 7 days.Serum samples were collected after vaccination for determining the seroconversion rates and antibody levels.Results Most of the reactions were mild in period of observation,and there were no abnormal liver function and severe reactions such as rashes,adverse events related with the vaccine.The seroconversion rate was 98.2％ after 2 months of vaccination,the geometric mean titer of anti-HAV was 135.5 mIU/mL.Conclusions The study indicates that freeze-dried live attenuated hepatitis A vaccine without gelatin and human albumin is safe and has a good immunogenicity.