应用实时细胞分析系统评价甲型H1N1流感病毒疫苗免疫原性和安全性

发布时间：2018-03-28 14:10

本文选题：甲型H_1N_1流感病毒疫苗　切入点：实时细胞分析系统　出处：《复旦大学》2011年硕士论文

【摘要】：目的：验证实时细胞分析系统可用于检测血清中和抗体滴度；评估甲型H1N1流感病毒裂解灭活疫苗的免疫原性和安全性。研究方法：验证实时细胞分析系统是否可用于动态监测流感病毒导致的细胞病变效应和检测血清中和抗体滴度；分析比较实时细胞分析系统和血凝抑制试验两种方法检测血清抗体的符合率和相关性；在此基础上,应用实时细胞分析系统和血凝抑制试验检测血清标本抗体滴度,分析比较接种前后血清抗体平均滴度、抗体转阳率和抗体保护率以评估疫苗的免疫原性；描述性分析不良事件发生率和严重程度以评估疫苗的安全性。结果：本研究证实,实时细胞分析系统可用于监测流感病毒致细胞病变效应(CPE),实时细胞分析系统和血凝抑制试验两种方法检测结果具有较高的符合率,免疫后7d和21d时两种检测方法的符合率分别为70.0%和65.0%,两种检测方法直线回归分析显示,两种检测方法之间具有直线回归关系(免疫前和免疫后7d的决定系数分别为Rod2=0.8213 R7d2=0.6676,P0.0001)；甲型H1N1流感病毒裂解灭活疫苗接种后血清抗体滴度逐渐升高,免疫后21d时,血凝抑制抗体平均滴度升高至1：95.27,82.1%(101/123)志愿者的抗体滴度达1：40或以上,血清中和抗体平均滴度升高至1：525.44,100%的志愿者血清中和抗体滴度达1：160或以上；且免疫前血清抗体状态对免疫后血清抗体滴度的升高无明显影响。136位志愿者接种疫苗后总不良事件发生率为36.0%,其中局部不良反应和全身不良事件发生率分别为19.1%和22.1%。接种部位疼痛(14.0%)和乏力(12.5%)分别是最常见的局部不良事件和全身不良事件。就严重程度而言,多数不良事件属轻度,少数为中度不良事件,未见重度不良事件及死亡事件。结论：实时细胞分析系统可用于检测血清中和抗体,绝大多数成人接种1剂(15μg)甲型H1N1流感病毒裂解灭活疫苗可实现血清抗体转阳,产生有效的抗甲型H1N1流感病毒感染的保护性。人群对甲型H1N1流感病毒裂解灭活疫苗普遍耐受,不良事件以轻中度为主,严重不良事件罕见。(国际注册号：ClinicalTrials.gov number, NCT01055990)
[Abstract]:Objective: to verify that the real-time cell analysis system can be used to detect serum neutralization antibody titers. To evaluate the immunogenicity and safety of inactivated influenza A (H1N1) virus lytic vaccine. Methods: to verify whether the real-time cell analysis system can be used to dynamically monitor the cytopathic effect caused by influenza virus and to detect serum neutralization antibody titer. The coincidence rate and correlation between real-time cell analysis system and hemagglutination inhibition test were analyzed and compared, and the titer of serum antibody was detected by real-time cell analysis system and hemagglutination inhibition test. To evaluate the immunogenicity of the vaccine by comparing the average titer of serum antibody, antibody conversion rate and antibody protection rate before and after inoculation, descriptive analysis of the incidence and severity of adverse events in order to assess the safety of the vaccine. The real-time cell analysis system can be used to monitor the cytopathic effect of influenza virus. The results of real-time cell analysis system and hemagglutination inhibition test have a high coincidence rate. The coincidence rates of the two methods were 70.0% and 65.0% respectively on day 7 and day 21 after immunization. There was a linear regression relationship between the two methods (the determinant coefficients of Rod2=0.8213 R7d2 and 7 days after immunization were Rod2=0.8213 R7d2, 0.6676G, P0.0001, respectively. The titer of serum antibody increased gradually after inoculation with inactivated influenza A H1N1 vaccine, and the titer of serum antibody increased 21 days after immunization. The average titer of hemagglutination suppressor antibody increased to 1: 95.27 / 82.1and the titer of serum neutralization antibody increased to 1: 525.44100% (1: 160 or above). The average titer of hemagglutination suppressor antibody increased to 1:40 or more than 101r123.The average titer of serum neutralizing antibody increased to 1: 525.44100%. The incidence of total adverse events after vaccination in 136 volunteers was 36.0, in which the incidence of local adverse reactions and systemic adverse events were 19.1%, respectively. The most common local adverse events and systemic adverse events were local adverse events and systemic adverse events, respectively. In terms of severity, Most of the adverse events were mild, a few were moderate adverse events, no severe adverse events and death events. Conclusion: the real-time cell analysis system can be used to detect serum neutralization antibody. The vast majority of adults were inoculated with a dose of 15 渭 g / 1 H1N1 influenza virus lytic inactivated vaccine to achieve serum antibody conversion, and to produce effective protection against influenza A H1N1 virus infection. The population was generally tolerant of H1N1 influenza virus lytic inactivated vaccine. Adverse events are mainly mild and moderate, and severe adverse events are rare. (international Registration No.:: clinical Trials.gov number, NCT01055990)
【学位授予单位】：复旦大学
【学位级别】：硕士
【学位授予年份】：2011
【分类号】：R392

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