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原代沙鼠肾细胞流行性出血热双价疫苗临床观察与免疫学效果研究 |
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董关木 安祺 朱智勇 刘光中 何雅慧 俞永新
丁晓航 宋斌 刘文雪 孙光 孔艳 朱凤才 王英军
【摘要】 目的 对新近研制成功的沙鼠肾原代细胞培养的流行性出血热双价疫苗（汉滩型+汉城型）进行Ⅱ期临床扩大观察，考核其对人体的安全性和中和抗体反应。方法 将观察人群设在不同地区，分别选择中国南方和北方两个点，每个点接种500人的双价疫苗，同时接种250人的商品化单价疫苗（汉滩型）作对照，观察接种对象的副反应程度和采集其血清样品测定荧光抗体和以蚀斑减少中和法测定中和抗体，考核疫苗效果。结果 观察结果显示，在观察的280人中分别有7人呈现轻度局部副反应和37.5℃以下低热的全身反应，总反应率分别为2.5%。IFA抗体阳转率100%，GMT 1∶67。中和抗体阳转率汉滩型为87.6%，汉城型为96.3%（n=81）。如果以同一份血清中任何单一血清型阳转来计算，阳转率为100%。以同一份血清两个血清型均需阳转来计算，则阳转率为75.3%（61/81）。结论 经过Ⅱ期临床人体观察结果显示，该双价疫苗仅有轻度局部反应和良好的中和抗体应答。证明该疫苗对人体安全，具有较好的免疫原性。
【主题词】 出血热，流行性 疫苗 荧光抗体技术 中和试验
Expanded human trial of the bivalent HFRS inactivated vaccine made from M.gerbels kidney tissue culture Dong Guanmu*,Zhu Zhiyong, Yu Yongxin et al.*National lnstitute for the Control of Pharmaceutical and Biological Products,Beijing 100050
【Abstract】 Objective Expanded human trial (Phase II) for observing the safety and neutralizing antibodies response of a newly developed bivalent ( HTN+SEO type) HFRS inactivated vaccine made from M.Gerbels kidney tissue culture. Methods For observing the different responses subjects living in the different parts of volunteers were selected from southern and northern parts. Each group including 500 subjects to be vaccinated with bivalent and 250 with commercial univalent HTN vaccine as control. Side reactions were observed and serum samples were taken from the volunteers of each group and tested for the antibody responses by IFA and PRNT serological methods.Results The results showed that 7 volunteers got slight local reaction and 7 persons developed systemic reaction with temperature of <37.5C (n=280).The total reaction rate was 2.5%. The seroconversion rate of neutralizing antibodies against Hantaan type and Seoul type were 87.6% and 96.3% (n=81) respectively. The positive rate would be 100% by such calculation that one of the samples showed positive to either type. However, if one of the samples was positive to both types the positive rate was 75%[1] [2] 下一页
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