进口加拿大流行性感冒裂解疫苗临床安全性与免疫原性评价

目的 评价加拿大Shire公司生产的流行性感冒(流感)裂解疫苗的安全性和免疫原性。方法 按整群随机抽样原则，以进口同类疫苗作为对照开展现场临床试验；比较两种流感疫苗免疫后临床反应率、抗体阳转率、保护率及几何平均滴度(GMT)。结果 试验组发热反应率(3．69％)及局部反应率(1．75％)与对照组相比较，两组间差异无统计学意义。试验组、对照组免疫后H1N1、H3N2、B型抗体阳转率分别为96．8％、95．8％、52．3％和92．3％、90．2％、62．3％；结果显示两种流感疫苗间阳转率差异有统计学意义。试验组和对照组的H1N1、H3N2及B(亚)型抗体GMT平均增长倍数分别为22．4、16．8、8．2倍和21．2、12．5、7．4倍；试验组免疫后H1N1、H3N2、B型抗体保护率(99％、99％、53．9％)与对照组免疫后三型保护率(96．2％、98．4％、62．3％)差异无统计学意义。结论 加拿大Shire公司生产的流感裂解疫苗发热反应和局部反应与进口同类疫苗无差异，临床安全性良好；免疫后抗体阳转率较高，抗体滴度上升幅度较大，具有良好的免疫原性。

Evaluation on the safety and immunogenicity of Canada split influenza virus vaccine

OBJECTIVE: To evaluate the safety and immunogenicity of Canada split influenza virus vaccine. METHODS: Cluster samples were by randomly chosen and divided into split vaccination group and homoimported influenza vaccination group. RESULTS: After injection, fever-reaction and local reaction rates of 'trial' group were found as 3.69% and 1.75% respectively, but no statistical significance was found when compared with 'control' group. However the antibody positive rates of 'trail' and 'control' groupsappeared statistically significant (H1N1: 96.8% vs. 92.3%, H3N2: 95.8% vs. 90.2%, B: 52.3% vs. 62.3%). For geometric mean titer (GMT) of type H1N1, H3H2 and B antibody, 'trial' group and 'control' group increased 22.4, 16.8, 8.2 and 21.2, 12.5 and 7.4 times respectively. The antibody protective rates of type H1N1, H3N2 and B were 99%, 99% and 53.9% for 'trial' group, and 96.2%, 98.4% and 62.3% for 'control' but with no statistically significant difference. CONCLUSION: Influenza split vaccine made in Shire company in Canada was safe and with good immunogenicity.