| 李荣成,方捍华,李艳萍,刘幼平,农艺,黄贵彪.MF59-佐剂流感亚单位疫苗在中国老年人中的免疫原性和安全性研究[J].Chinese journal of Epidemiology,2008,29(6):548-551 |
| MF59-佐剂流感亚单位疫苗在中国老年人中的免疫原性和安全性研究 |
| Study on the safety and immunogenicity of MF59-adjuvanted influenza subunit vaccine in Chinese elderly |
| Received:March 07, 2008 |
| DOI：10.3321/j.issn:0254-6450.2008.06.008 |
| KeyWord: 流感疫苗|免疫原性|安全性|老年人 |
| English Key Word: Influenza vaccine|Immunogenicity|Safety|Elderly |
| FundProject: |
| Author Name | Affiliation | | LI Rong-cheng | Vaccine Clinical Trial, Guangxi Zhuang Autongmous Region Centre for Disease Control and Prevention, Nanning 530028, China | | FANG Han-hua | 中国药品生物制品检定所 | | LI Yan-ping | Vaccine Clinical Trial, Guangxi Zhuang Autongmous Region Centre for Disease Control and Prevention, Nanning 530028, China | | LIU You-ping | Vaccine Clinical Trial, Guangxi Zhuang Autongmous Region Centre for Disease Control and Prevention, Nanning 530028, China | | NONG Yi | Vaccine Clinical Trial, Guangxi Zhuang Autongmous Region Centre for Disease Control and Prevention, Nanning 530028, China | | HUANG Gui-biao | Vaccine Clinical Trial, Guangxi Zhuang Autongmous Region Centre for Disease Control and Prevention, Nanning 530028, China |
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| Abstract: |
| 目的 比较MF59-佐剂流感亚单位疫苗与传统的非佐剂流感亚单位疫苗在老年人中的安全性和免疫原性．方法 采用随机、研究者设盲的对照研究，按照2:1的比例分别给予600名60岁以上老年人接种MF-59佐剂流感亚单位疫苗(复立达TM，简称佐剂流感疫苗)和传统的非佐剂流感亚单位疫苗(爱阁力保(R)，简称传统亚单位疫苗)，观察接种日和接种后7天内的局部反应和全身反应;使用血凝抑制试验检测接种老年人免疫前后的血凝抑制抗体(HI)滴度，计算基线无免疫保护状态受试者的抗体4倍增长阳转率、免疫后HI抗体达到保护水平(≥1:40)的保护率以及抗体GMT值和增长倍数．比较两者在安全性和免疫原性的差异．结果 两组疫苗的局部反应和全身反应相似，但传统亚单位疫苗组(n=200)中注射部位的硬结相对常见(P＜0.05)，而佐剂流感疫苗组(n=400)中注射部位轻度疼痛和发热则相对较常见．对于基线无免疫保护状态的受试者，免疫后针对A/H3N2病毒株的抗体阳转率，佐剂流感疫苗组显著高于传统亚单位疫苗组(P＜0.001);除A/H1N1病毒株外，与基线相比，两组疫苗的保护率均有显著提高，但针对A/H3N2病毒株的保护率方面，佐剂流感疫苗显著高于传统亚单位疫苗(P＜0.001);两组疫苗接种后的GMT均比基线明显增加(P＜0.001)，但佐剂流感疫苗组明显高于传统亚单位疫苗组．结论 中国老年人对佐剂流感疫苗耐受性良好，佐剂流感疫苗诱导的免疫原性水平比传统亚单位疫苗高，可使免疫力低下的老年人获益更大． |
| English Abstract: |
| Objective To compare the safety and immunogenicity between a MF59-adjuvanted influenza subunit vaccine and a conventional non-adjuvanted influenza subunit vaccine.Methods A randomized, blind-designed controlled study was carried out, with 600 subjects (≥60 years of age)received MF59-adjuvanted influenza subunit vaccine (FLUAD(R), n=400) or conventional non-adjuvanted influenza subunit vaccine (Agrippal(R), n= 200) respectively. The local and systemic reactions were observed on 0-7 days after vaccination. Haemagglutination inhibition (HI) titers of pre-and post-vaccination were detected by the HI assay. Seroconversion (4-fold increase) rate of subjects was calculated using baseline data when it was under naive level, and the protection rate when HI titer achieving the level of protection(≥1:40) after vaccination.Geometric mean titer(GMT) and its increasing folds were calculated.Differences between safety and immunogenicity were also calculated. Results The local and systemic reaction rates were similar between both groups, but the duration in injection site was frequent for Agrippal(R)(P＜0.05), while mild pain and fever in injection site were frequent for FLUAD(R). On immunogenicity test, for those subjects whose baseline was under naive level while the seroconversion rate against A/H3N2 viral strain after vaccination - FLUAD(R) was significantly higher than Agrippal(R) (P＜0.001). Aside from A/H1N1 viral strain, the rate of protection on both groups were significantly higher than those from baseline data, but for A/H3N2 viral strain, FLUAD(R) was significantly higher than Agrippal(R) (P＜0.001 ). GMT was higher than baseline (P＜0.001 ) after both groups being vaccinated but FLUAD(R) group was significantly higher than Agrippal(R) group. Conclusion FLUAD(R) was well tolerated by Chinese elderly and its immunogenicity level induced by FLUAD(R) was higher than that of Agrippal(R), showing that it would benefit the elderly with hypoimmunity. |
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