Foot-and-mouth disease (FMD) is an infectious and sometimes fatal viral disease that affects cloven-hoofed animals, and Chinese government adopts compulsory immunization measures for FMD. The adverse effects of FMD va...Foot-and-mouth disease (FMD) is an infectious and sometimes fatal viral disease that affects cloven-hoofed animals, and Chinese government adopts compulsory immunization measures for FMD. The adverse effects of FMD vaccine to pigs, cattle and goats have been reported increasingly frequent during the spring and autumn seasons when large numbers of farm livestock are vaccinated. The financial losses caused by vaccine adverse effects have been a serious concern for both farmers and primary prevention personnel. There are various causative factors reported to involve into adverse effect of FMD vaccine, including the inappropriate vaccine production, transportation and storage, livestock poor tolerance, and unqualified vaccinating manipulations. Symptomatic treatment and early drug prevention have a certain effect on the adverse effects. To analyze causes and propose countermeasures, in the current study possible reasons during the production and processing procedures of inactivated FMD vaccine were reviewed and corresponding countermeasures were recommended. The review may provide references for better use of vaccine to prevent FMD.展开更多
Hand,foot,and mouth disease(HFMD)recently emerged as a global public threat.The licensure of inactivated enterovirus A71(EV-A71)vaccine was the first step in using a vaccine to control HFMD.New challenges arise from c...Hand,foot,and mouth disease(HFMD)recently emerged as a global public threat.The licensure of inactivated enterovirus A71(EV-A71)vaccine was the first step in using a vaccine to control HFMD.New challenges arise from changes in the pathogen spectrum while vaccines directed against other common serotypes are in the preclinical stage.The mission of a broad-spectrum prevention strategy clearly favors multivalent vaccines.The development of multivalent vaccines was attempted via the simple combination of potent monovalent vaccines or the construction of chimeric vaccines comprised of epitopes derived from different virus serotypes.The present review summarizes recent advances in HFMD vaccine development and discusses the next steps toward a safe and effective HFMD vaccine that is capable of establishing a crossprotective antibody response.展开更多
【背景】口蹄疫疫苗质量评价方法对疫苗生产企业和监管部门进行质量控制尤为重要,146S抗原含量是评价口蹄疫疫苗质量的关键指标。蔗糖密度梯度离心法(sucrose density gradient centrifugation,SDGC)是公认经典的测定口蹄疫146S抗原含...【背景】口蹄疫疫苗质量评价方法对疫苗生产企业和监管部门进行质量控制尤为重要,146S抗原含量是评价口蹄疫疫苗质量的关键指标。蔗糖密度梯度离心法(sucrose density gradient centrifugation,SDGC)是公认经典的测定口蹄疫146S抗原含量的方法,但存在检测耗时长、过程复杂、重复性差等缺点,影响了疫苗的质量监测。口蹄疫灭活疫苗146S抗原含量高效液相体积排阻色谱法(size-exclusion high-performance liquid chromatography,SE-HPLC)是一种简便、快速、自动化程度高、高效的测定方法。【目的】在初步建立的采用SE-HPLC测定口蹄疫灭活疫苗146S抗原含量方法的基础上,针对不同类型、不同浓缩纯化生产工艺制备的口蹄疫灭活疫苗,进一步确认SE-HPLC法在检测过程中的普适性势在必行。【方法】利用口蹄疫146S抗原标准品建立SE-HPLC法标准曲线,求得回归方程,用于检测样品的146S含量。采用SE-HPLC法和SDGC法分别检测146S抗原标准品1倍、2倍、4倍、8倍、16倍稀释的5个样品和市场上随机选取的22批疫苗,计算146S抗原含量,对比分析两种方法的相关性。用SE-HPLC法,3次重复检测不同企业生产的134批口蹄疫灭活疫苗146S抗原含量,通过色谱图特异性、检测值相对标准偏差(relative standard deviation,RSD)分析SE-HPLC法的重复性,评价该方法的适用性,分析市场流通疫苗的总体质量情况。【结果】SE-HPLC法建立的标准曲线,峰面积与146S抗原含量的线性关系良好(R^2=0.9981,n=8)。口蹄疫146S抗原标准品5个稀释样品和22批口蹄疫疫苗的146S抗原含量检测结果表明,口蹄疫146S抗原含量检测SDGC法和SE-HPLC法高度正相关(RS^2=0.9994,nS=5;Rv 2=0.9602,nv=22)。134批口蹄疫灭活疫苗中,146S抗原含量相对标准偏差RSD<5%的疫苗批次分别占疫苗总批次(134批)、单价苗总批次(18批)、双组分及双价苗总批次(76批)、三价苗总批次(40批)的81.34%、72.22%、85.53%、80.00%;146S抗原含量相对标准偏差RSD≤10%的疫苗批次占疫苗总批次(134批)的97.76%。口蹄疫146S抗原含量SE-HPLC法检测重复性良好,其中疫苗146S抗原含量2—4μg·mL^-1时,检测重复性最好。所有批次疫苗均检测到目的峰,目的峰的平均起峰、最高峰、落峰时间分别为SE-HPLC法进样后的11.58、12.90、14.93min,平均持续3.36min。134批口蹄疫灭活疫苗146S抗原含量为1.11—80.36μg·mL^-1,其中单价苗、双价苗、双组分苗、三价苗146S抗原含量均值分别为2.07、2.40、2.85、13.14μg·mL^-1。【结论】口蹄疫灭活疫苗146S抗原含量SE-HPLC法适用性好、重复性高、高效、快速、简便,能够用于检测不同类型的口蹄疫灭活疫苗,从而进行疫苗的质量监测和评估。市场流通的口蹄疫灭活疫苗146S含量较高,疫苗质量较好。展开更多
文摘Foot-and-mouth disease (FMD) is an infectious and sometimes fatal viral disease that affects cloven-hoofed animals, and Chinese government adopts compulsory immunization measures for FMD. The adverse effects of FMD vaccine to pigs, cattle and goats have been reported increasingly frequent during the spring and autumn seasons when large numbers of farm livestock are vaccinated. The financial losses caused by vaccine adverse effects have been a serious concern for both farmers and primary prevention personnel. There are various causative factors reported to involve into adverse effect of FMD vaccine, including the inappropriate vaccine production, transportation and storage, livestock poor tolerance, and unqualified vaccinating manipulations. Symptomatic treatment and early drug prevention have a certain effect on the adverse effects. To analyze causes and propose countermeasures, in the current study possible reasons during the production and processing procedures of inactivated FMD vaccine were reviewed and corresponding countermeasures were recommended. The review may provide references for better use of vaccine to prevent FMD.
基金sponsored by the National Natural Science Foundation of China(81672018)the National 13th Five-Year Grand Program on Key Infectious Disease Control(2017ZX10202102)+2 种基金the 13th Five-Year National Science and Technology Major Project for infectious Diseases(2017ZX10305501-002)Shanghai Pujiang Program(19PJ1409100)the Technology Service Platform for Detecting High level Biological Safety Pathogenic Microorganism Supported by Shanghai Science and Technology Commission(18DZ2293000)。
文摘Hand,foot,and mouth disease(HFMD)recently emerged as a global public threat.The licensure of inactivated enterovirus A71(EV-A71)vaccine was the first step in using a vaccine to control HFMD.New challenges arise from changes in the pathogen spectrum while vaccines directed against other common serotypes are in the preclinical stage.The mission of a broad-spectrum prevention strategy clearly favors multivalent vaccines.The development of multivalent vaccines was attempted via the simple combination of potent monovalent vaccines or the construction of chimeric vaccines comprised of epitopes derived from different virus serotypes.The present review summarizes recent advances in HFMD vaccine development and discusses the next steps toward a safe and effective HFMD vaccine that is capable of establishing a crossprotective antibody response.
文摘【背景】口蹄疫疫苗质量评价方法对疫苗生产企业和监管部门进行质量控制尤为重要,146S抗原含量是评价口蹄疫疫苗质量的关键指标。蔗糖密度梯度离心法(sucrose density gradient centrifugation,SDGC)是公认经典的测定口蹄疫146S抗原含量的方法,但存在检测耗时长、过程复杂、重复性差等缺点,影响了疫苗的质量监测。口蹄疫灭活疫苗146S抗原含量高效液相体积排阻色谱法(size-exclusion high-performance liquid chromatography,SE-HPLC)是一种简便、快速、自动化程度高、高效的测定方法。【目的】在初步建立的采用SE-HPLC测定口蹄疫灭活疫苗146S抗原含量方法的基础上,针对不同类型、不同浓缩纯化生产工艺制备的口蹄疫灭活疫苗,进一步确认SE-HPLC法在检测过程中的普适性势在必行。【方法】利用口蹄疫146S抗原标准品建立SE-HPLC法标准曲线,求得回归方程,用于检测样品的146S含量。采用SE-HPLC法和SDGC法分别检测146S抗原标准品1倍、2倍、4倍、8倍、16倍稀释的5个样品和市场上随机选取的22批疫苗,计算146S抗原含量,对比分析两种方法的相关性。用SE-HPLC法,3次重复检测不同企业生产的134批口蹄疫灭活疫苗146S抗原含量,通过色谱图特异性、检测值相对标准偏差(relative standard deviation,RSD)分析SE-HPLC法的重复性,评价该方法的适用性,分析市场流通疫苗的总体质量情况。【结果】SE-HPLC法建立的标准曲线,峰面积与146S抗原含量的线性关系良好(R^2=0.9981,n=8)。口蹄疫146S抗原标准品5个稀释样品和22批口蹄疫疫苗的146S抗原含量检测结果表明,口蹄疫146S抗原含量检测SDGC法和SE-HPLC法高度正相关(RS^2=0.9994,nS=5;Rv 2=0.9602,nv=22)。134批口蹄疫灭活疫苗中,146S抗原含量相对标准偏差RSD<5%的疫苗批次分别占疫苗总批次(134批)、单价苗总批次(18批)、双组分及双价苗总批次(76批)、三价苗总批次(40批)的81.34%、72.22%、85.53%、80.00%;146S抗原含量相对标准偏差RSD≤10%的疫苗批次占疫苗总批次(134批)的97.76%。口蹄疫146S抗原含量SE-HPLC法检测重复性良好,其中疫苗146S抗原含量2—4μg·mL^-1时,检测重复性最好。所有批次疫苗均检测到目的峰,目的峰的平均起峰、最高峰、落峰时间分别为SE-HPLC法进样后的11.58、12.90、14.93min,平均持续3.36min。134批口蹄疫灭活疫苗146S抗原含量为1.11—80.36μg·mL^-1,其中单价苗、双价苗、双组分苗、三价苗146S抗原含量均值分别为2.07、2.40、2.85、13.14μg·mL^-1。【结论】口蹄疫灭活疫苗146S抗原含量SE-HPLC法适用性好、重复性高、高效、快速、简便,能够用于检测不同类型的口蹄疫灭活疫苗,从而进行疫苗的质量监测和评估。市场流通的口蹄疫灭活疫苗146S含量较高,疫苗质量较好。
