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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4444%(8/18)。1年后,IFA抗体和中和抗体阳性率分别下降到2857%和1480%。但加强后两周的血清,IFA抗体和中和抗体分别反弹至8333%和5556%,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225%和260%。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9570%。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?
In the vaccine trial throughout the vaccination of 10,178 people, and set the control group of 16,203 people. From August 1995 to September 1998 three years after vaccination began to enhance the vaccine two years later, observed HFRS type Ⅰ mice inactivated purified vaccine safety and epidemiological protection rate effect. Looking at the results: The vaccine proved to be safe except for the more common and localized reactions caused by sucrose in the vaccine. Serum immunization results showed that IFA antibody positive rate was 100% and neutralizing antibody positive rate was 4444% (8/18) in the sera of 86 immunized patients after two weeks of inoculation. After 1 year, the positive rates of IFA antibody and neutralizing antibody decreased to 2857% and 1480% respectively. However, two weeks after the boost, the IFA and neutralizing antibodies rebounded to 8333% and 5556%, respectively, and the geometric mean titers of the antibodies also rose, but not significantly. In addition, the positive rates of IFA and neutralizing antibodies in the two years after the booster had dropped to 22.5% and 26.0%, respectively. In the whole course of inoculation population, one case was inoculated with 2 needles and one with 3 inoculations but did not inoculate according to the prescribed inoculation procedures. So far, no other cases occurred in inoculation group. In the control group, 22 cases had been reported and the average protection rate in 3 years was 95.7%. In conclusion, the vaccine is safe and effective, and the results confirmed that the vaccine has better serum immune effect and better epidemic prevention effect. There seems to be an immune-enhancing reaction, but no enhanced response to infection (inoculation group 2 patients clinical manifestations?