| 郭万申,徐瑾,吴俊燏,赵升,何红霞,师文俊,于丹,李晶,高虹,陈江婷.季节性流感裂解疫苗安尔来福®up>®的安全性、免疫原性及与H7N9禽流感病毒的交叉免疫研究[J].Chinese journal of Epidemiology,2014,35(8):949-952 |
| 季节性流感裂解疫苗安尔来福®up>®的安全性、免疫原性及与H7N9禽流感病毒的交叉免疫研究 |
| Safety and immunogenicity of seasonal inactivated influenza vaccine（split virion）and cross- reactive antibody responses to the H7N9 avian influenza virus |
| Received:March 05, 2014 |
| DOI：10.3760/cma.j.issn.0254-6450.2014.08.016 |
| KeyWord: 季节性流感裂解疫苗 免疫原性 安全性 H7N9禽流感 交叉免疫反应 |
| English Key Word: Seasonal influenza vaccine（split virion） Immunogenicity Safety H7N9 avian influenza virus Cross-reaction |
| FundProject: |
| Author Name | Affiliation | E-mail | | Guo Wanshen | Henan Provincial Center for Disease Control and Prevention, Zhengzhou 450016, China | | | Xu Jin | Henan Provincial Center for Disease Control and Prevention, Zhengzhou 450016, China | | | Wu Junyu | Sinovac Biotech Co., Ltd | | | Zhao Sheng | Henan Provincial Center for Disease Control and Prevention, Zhengzhou 450016, China | | | He Hongxia | Yuanyang Country Center for Disease Control and Prevention, Henan | | | Shi Wenjun | Yuanyang Country Center for Disease Control and Prevention, Henan | | | Yu Dan | Sinovac Biotech Co., Ltd | | | Li Jing | Sinovac Biotech Co., Ltd | | | Gao Hong | Sinovac Biotech Co., Ltd | | | Chen Jiangting | Sinovac Biotech Co., Ltd | chenjt@sinovac.com |
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| Abstract: |
| 目的 评价季节性流感裂解疫苗（安尔来福®）的免疫原性及安全性，分析与H7N9禽流感病毒的交叉免疫反应。方法 采用临床研究开放式设计，选择6～35月龄婴幼儿（免疫接种方式：2针，0、28 d）、18～60岁成年人及>60岁老年人（1针）接种安尔来福®。所有接种者免疫后均接受安全性观察，并采集成年人和老年人免疫前后21 d的血清标本，利用血凝抑制试验（HI）检测疫苗3种（甲型流感2种和乙型流感1种）病毒株以及H7N9禽流感病毒抗体。采用欧盟流感疫苗临床研究标准（欧盟标准）评价疫苗免疫效果。结果 共202（婴幼儿65、成年人69及老年人68）人完成接种和安全性观察。不良反应发生率为12.4%（25/202），以全身不良反应为主，未见严重不良反应。有124（成年人64、老年人60）人采集到免疫前后配对血清。接种疫苗后21 d，成年组3个型别HI抗体阳转率为78.1%～90.6%，抗体保护率为92.2%～100.0%，GMT增长7.9～41.0倍；老年组HI抗体阳转率为66.7%～83.3%，抗体保护率为86.7%～100.0%，GMT增长5.7～20.4倍。均达到欧盟标准。而接种疫苗后，成年组和老年组抗H7N9抗体阳性率和阳转率仍保持为零，GMT增长仅1.2～1.4倍。结论 季节性灭活流感裂解疫苗的安全性和免疫原性良好，但对H7N9禽流感病毒无交叉免疫反应。 |
| English Abstract: |
| Objective To evaluate the safety and immunogenicity of seasonal inactivated influenza vaccine (split virion)and to analyze its cross-reactive antibody responses to H7N9 avian influenza virus. Methods An open-labeled clinical trial was carried out in infants aged 6-35 months,adults aged 18-60 years and the elderly aged >60 years. After vaccinations (one dose for adults and the elderly and two doses for infants),adverse events were observed. Serum samples were obtained before vaccination and 21 days after vaccination from adults and elderly subjects. Three types of antibody against seasonal influenza virus and antibody against H7N9 avian influenza virus were tested using microhemagglutination inhibition(HI) assay. Immunogenicity of the vaccine was evaluated based on the immunogenicity criteria for adults and the elderly,set by the Committee for Medicinal Products for Human Use (CHMP) for the European Medicines Agency. Results A total of 202 subjects (65 infants,69 adults and 68 elderly) were enrolled and injected for at least one dose. The overall rate of adverse events was 12.4%(25/202) and most of them were under systemic reaction. No serious adverse event was reported. Pre- and post-vaccination serum samples were collected from 124 subjects (64 adults,60 elderly). After 21 days of vaccination,the sero-conversion rate,sero-protection rate,and geometric mean titer(GMT) ratio(post-/pre-vaccination) of antibody against seasonal influenza virus were 78.1%-90.6%,92.2%-100.0% and 7.9-41.0 among adults while 66.7%-83.3%,86.7%-100.0% and 5.7-20.4 among the elderly,respectively. However,after vaccination,both sero-conversion rate and sero-protection rate of antibody against H7N9 avian influenza virus among adults and the elderly became zero,with GMT ratio between 1.2 and 1.4. Conclusion This trial vaccine appeared to have good safety and immunogenicity but inducing no cross-reactive antibody response to H7N9 avian influenza virus. |
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