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| 国产流行性感冒裂解疫苗临床安全性与免疫原性评价研究 | |
| 引用本文： | 胡月梅,宋俐,茅群霞,梁祁,潘红星,方捍华,余录根,张才军,朱凤才. 国产流行性感冒裂解疫苗临床安全性与免疫原性评价研究[J]. 疾病监测, 2007, 22(5): 322-324. DOI: 10.3784/j.issn.1003-9961.2007.5.322 |
| 作者姓名： | 胡月梅 宋俐 茅群霞 梁祁 潘红星 方捍华 余录根 张才军 朱凤才 |
| 作者单位： | 江苏省疾病预防控制中心,南京,210009;中国药品生物制品研究所;江苏省溧水县疾病预防控制中心;溧水县柘塘中心卫生院 |
| 摘 要： | 目的 评价国产流行性感冒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 试验组及对照组接种后均无发热反应,局部反应率分别为1.8%和2.1%(P＞0.05),均为轻度反应;试验疫苗流感病毒H1N1、H3N2及B(亚)型的微量血凝抑制试验(HI)抗体总阳转率分别为93.6%、80.4%、88.8%,对照疫苗流感病毒H1N1、H3N2及B(亚)型的HI抗体总阳转率分别为89.0%、77.3%、86.6%,H1N1(亚)型HI抗体总阳转率试验组高于对照组,差异有统计学意义.试验疫苗流感病毒H1N1、H3N2及B(亚)型HI抗体增长倍数分别为23.9倍、8.6倍和12.9倍;对照疫苗流感病毒H1N1、H3N2及B(亚)型HI抗体增长倍数分别为20.0倍、6.6倍和9.7倍.HsN2、B(亚)型流感抗体增长倍数试验组高于对照组,差异有统计学意义.试验疫苗流感病毒H1N1、H3N2及B(亚)型HI抗体达到保护水平的保护率分别为94.8%、99.4%和87.0%;对照疫苗流感病毒H1N1、H3N2及B(亚)型HI抗体达到保护水平的保护率分别为92.4%、100%和83.0%.三(亚)型流感HI抗体达到保护水平的保护率差异均无统计学意义.结论 国产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,部分指标优于进口同类疫苗,免疫后抗体阳转率较高,抗体滴度上升幅度较大,具有良好的临床安全性和免疫原性. |
| 关 键 词： | 流行性感冒裂解疫苗 临床安全性 免疫原性 |
| 文章编号： | 1003-9961（2007）05-0322-03 |
| 收稿时间： | 2006-08-14 |
| 修稿时间： | 2006-08-14 |
Evaluation of clinical safety and immunogenicity of influenza split vaccine made in China |
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| HU Yue- mei, SONG Li, MAO Qun-xia, Liang Qi,et al.. Evaluation of clinical safety and immunogenicity of influenza split vaccine made in China[J]. Disease Surveillance, 2007, 22(5): 322-324. DOI: 10.3784/j.issn.1003-9961.2007.5.322 | |
| Authors: | HU Yue- mei SONG Li MAO Qun-xia Liang Qi et al. |
| Affiliation: | 1.Jiangsu Provincial CDC;Nanjing;Jiangsu 21009 China |
| Abstract: | Objective The study was conducted to evaluate the safety and immunogenicity of influenza split vaccine.Methods Spot clinical trials were performed by grouped random sampling with imported vaccines of the same kind as the control group.The clinical reaction rate,antibody positive rate,protective rate and geometric mean titer(GMT)were taken into comparison.Results No post-inoculation pyrogenetic reaction were observed in both trial group and control group,the local reaction rates being 1.8% and 2.1%(P>0.05),respectively,indicating slight reactions.The HI antibody positive rates of trial vaccine H1N1,H3N2 and B were respectively 93.6%,80.4% and 88.8%,while the rates of control vaccine H1N1,H3N2 and B were respectively 89.0%,77.3% and 86.6%.The total HI antibody positive rate in trial group was higher than in control group with statistical significance.The HI antibody increases of H1N1,H3N2 and B were averagely 23.9,8.6 and 12.9 times in trial group and 20.0,6.6 and 9.7 times in control group.The HI antibody increase in trial group was higher than in control group with statistical significance.The antibody protective rates of H1N1,H3N2 and B were respectively 94.8%,99.4% and 87.0% in trial group and 92.4%,100% and 83.0% in control group without statistical difference.Conclusion The influenza split vaccine made in China has no difference with imported vaccine of the same kind in pyrogenetic reactions,some indexes even better.Its post-inoculation antibody positive rate is higher and the increase of antibody titer larger.It has satisfying clinical safety and immunogenicity. |
| Keywords: | influenza split vaccine clinical safety immunogenicity |
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