肾综合征出血热疫苗效果免疫(感染)增强和免疫策略研究专题报告

Evaluation on Efficacy of Vaccines against HFRS and Study of the Strategy of Their Immunization

在疫苗试区全程接种了１０１７８人，并设对照组人群１６２０３人。１９９５年８月～１９９８年９月３年时间里从疫苗开始接种到加强后两年，观察了ＨＦＲＳⅠ型鼠脑灭活纯化疫苗的安全性和流行病学保护率效果等。纵观结果：证明该疫苗除了因疫苗中的蔗糖引起较重较普遍的局部反应外，疫苗的安全性是有保证的。从血清免疫效果看，８６例全程接种后两周的免疫者血清，ＩＦＡ抗体阳转率达１００％，中和抗体阳转率为４４４４％（８／１８）。１年后，ＩＦＡ抗体和中和抗体阳性率分别下降到２８５７％和１４８０％。但加强后两周的血清，ＩＦＡ抗体和中和抗体分别反弹至８３３３％和５５５６％，其抗体几何平均滴度也随之回升，但不十分明显。此外，在加强后２年的ＩＦＡ和中和抗体阳性率已下降到较低水平，分别为２２５％和２６０％。在全程接种人群中除１例因接种２针，１例虽接种３针，但未按规定接种程序进行接种而发病外，至今接种组未发生其他病例。而对照组人群中已发病２２例，其３年平均保护率达９５７０％。总之，该疫苗是安全和有效的，结果证实疫苗有较好的血清免疫效果和较好的流行病学防病效果。其中似乎存在免疫增强反应，但没有发现感染增强反应（接种组２例病人临床表现?

To evaluate the safety,immunogenicity and pretective efficacy of HFRS Ⅰ vaccine purified from sucking mouse brains,a controlled field trail was carried out in the endemic area of HFRS in Zhejiang province form August 1995 to September 1998.10178 volunteers were vaccinated while 16203 people living in the same areas were chosen as control group.The side effect of the vaccine was slight except for the high incidence of local pain caused by.No severe general reaction was ever found.Two weeks after three doses,the seroconvertion of the IFA and neutralizing anti Hantaan virus were 100%(86/86) and 44 44%(8/18) respectively.Just bdfore booster,one year after the basic immunization,the positive rate of IFA and PRNT dropped to 28.57% and 14.80%.Two weeks after the booster,both rates rebounded to 83.33% and 56.56% respectively.The changes of geometric mean titre(GMT) were probably the same.Two years after the booster,the seroprevelence of IFA and PRNT was 22.1% and 19.35%.During the three year kobservation,no HFRS patients were found among the vaccinees who received whole schedule vaccination ecept for one case who received only two doses patients were found in the control group,the epidemiological kprotective rate for three years was 95.70%.In short,the result suggested that the vaccine was safety and has good pretective effects.Idt may has immunological inhanced reaction but we did find infectious inhanced reaction in our study.It seems that the implementary injection and further observation are of great importance.