摘要
研究冻干甲型肝炎灭活疫苗免疫原性、安全性及热稳性 .分别将冻干及液体甲型肝炎灭活疫苗注射小白鼠和恒河猴 ,确定小白鼠 7d存活情况及恒河猴的谷丙转胺酶 (ALT)水平、肝脏病理、抗 -HAVIgG水平 .用同等剂量 (12 80EL·UmL-1)的冻干灭活疫苗与液体灭活疫苗初次及加强免疫后 1周 ,2组猴在食欲、活动性、大便频率及持续时间方面均无异常 ;5 2周观察期内未出现肝脏病理改变及ALT水平异常升高 .冻干灭活疫苗与液体灭活疫苗诱发的抗 -HAV水平无显著差异 ,2组IgG水平均在免疫后第 12周达到初次免疫后的最高水平 ,冻干疫苗组为 12 0 47mIUmL-1,液体疫苗组为 11875mIUmL-1.两组无显著差异 (P >0 .0 5 ) .第 2 4周分别加强免疫同等剂量疫苗后 ,第 2 8周抗 -HAVIgG水平显著提高 ,达到最高水平 ,冻干疫苗组为 412 15mIUmL-1,液体疫苗组为 40 874mIUmL-1.冻干剂型的甲型肝炎灭活疫苗具有液体剂型同样良好的安全性和免疫原性 .
The immmunogenicity and safty of lyophilizated inactivated hepatitis A vaccine were evaluated in mice (species Kunming) and rhesus monkeys ( Macaca Mulatta ). Mice and rhesus monkeys were inoculated with lyophilizated and aqueous inactivated hepatitis A vaccine to detect the living rates for mice and ALT,liver pathology and anti-HAV IgG in rhesus monkeys.No changes in appetite,activities or in frequency and consistency of stools were noted a week later after either dose of the primary or booster vaccinations with lyophilizated and aqueous inactivated hepatitis A vaccine.During the 52-week observation no abnormal elevation of ALT and liver pathology appeared.There was no statistically significant difference in anti-HAV IgG response between lyophilized and aqueous formulation in 52-week duration( P >0.05).The 100% of seroconversion rate were reached 2 weeks after vaccination with lyophilized and aqueous formulation.The first peak of IgG response appeared at week 12, 12?047?mIUmL -1 for lyophilized formulation,11?875?mIUmL -1 for aqueous one,and decreased gradually later for both formulation.The highest level of IgG appeared at week 28 after booster inoculation at week 24,41?215?mIUmL -1 for lyophilized for vaccine,40?874?mIUmL -1 for aqueous one,but there was no significant difference between two groups ( P >0.05).The lyophilized vaccine is as safe and well immmunogenic as aqueous vaccine.
出处
《云南大学学报（自然科学版）》
CAS
CSCD
2000年第3期237-240,共4页
Journal of Yunnan University(Natural Sciences Edition)
基金
国家"九五"攻关项目资助
关键词
甲型肝炎灭活疫苗
冻干剂型
免疫原性
安全性
Inactivated hepatitis A vaccine
lyophilization
immmunogenicity
safety
