季节性流感裂解疫苗在高抗体水平人群中的免疫原性
|
摘要
目的分析三价季节性流感裂解疫苗(SIV)在高抗体水平人群中的免疫原性。方法招募3-80岁健康人群1 200名,随机分为试验组和对照组分别接种本研究SIV和对照SIV,采集免疫前和免疫后28d血清,检测流感凝集抑制(HI)抗体,分析免疫前高抗体水平(抗体滴度≥1:10)人群免疫后抗体阳转率和几何平均滴度(GMT)增长幅度。结果试验组SIV免疫后H1N1、H3N2和B型流感HI抗体阳转率分别为78.3%(274/350)、74.1%(389/525)、69.8%(377/540);对照组分别为77.4%(254/328)、70.3%(374/532)、68.6%(376/548)。试验组免疫后与免疫前三个型别HI抗体GMT比值分别为10.4、8.8、5.9;对照组分别为9.7、6.5、5.8。结论 SIV在高抗体水平人群中具有良好的免疫原性。
Objective To determine the immunogenicity of seasonal influenza split-virus vaccine(SIV) among a highantibodylevel population. Methods We recruited 1 200 healthy individuals aged 3-80 years, and randomly allocated them into a study group and a control group who were vaccinated with the study SIV and a control SIV, respectively.We collected serum samples before and 28 days after vaccination to assess influenza HI antibody levels. We analyzed seroconversion rates and changes in geometric mean titers(GMT) of HI antibody after vaccination among subjects who had a high antibody level(antibody titer ≥1:10) before vaccination. Results Seroconversion rates of H1 N1, H3 N2 and B influenza HI antibodies were 78.3%(274/350), 74.1%(389/525), and 69.8%(377/540) in the study SIV group,respectively, and were 77.4%(254/328), 70.3%(374/532), and 68.6%(376/548) in the control SIV group. GMT ratios of three types of influenza HI antibodies af ter and before vaccination were 10.4, 8.8, and 5.9 in the study group,respectively, and were 9.7, 6.5, and 5.8 in the control group. Conclusion The study SIV had good immunogenicity among people with high antibody levels.
Objective To determine the immunogenicity of seasonal influenza split-virus vaccine(SIV) among a highantibodylevel population. Methods We recruited 1 200 healthy individuals aged 3-80 years, and randomly allocated them into a study group and a control group who were vaccinated with the study SIV and a control SIV, respectively.We collected serum samples before and 28 days after vaccination to assess influenza HI antibody levels. We analyzed seroconversion rates and changes in geometric mean titers(GMT) of HI antibody after vaccination among subjects who had a high antibody level(antibody titer ≥1:10) before vaccination. Results Seroconversion rates of H1 N1, H3 N2 and B influenza HI antibodies were 78.3%(274/350), 74.1%(389/525), and 69.8%(377/540) in the study SIV group,respectively, and were 77.4%(254/328), 70.3%(374/532), and 68.6%(376/548) in the control SIV group. GMT ratios of three types of influenza HI antibodies af ter and before vaccination were 10.4, 8.8, and 5.9 in the study group,respectively, and were 9.7, 6.5, and 5.8 in the control group. Conclusion The study SIV had good immunogenicity among people with high antibody levels.
引文
[1]沈艳华,王忠.甲型H1N1流感重症成年死亡患者RBC结果分析[J].国际检验医学杂志,2011,32(9):998-999.SHEN YH,WANG Z.Analysis on RBC results ofsevere adult death from influenza A(H1N1)[J].International Journal ofLaboratory Medicine,2011,32(9):998-999.
[2]曾祥兴,李康生.流感百年:20世纪流感大流行的回顾与启示[J].医学与社会,2010,23(11):4-6.ZENG XX,LI KS.The pandemic history ofinfluenza:review and revelation ofthe influenza pandemic in last century[J].Medicine and Society,2010,23(11):4-6.
[3]SHARMA S,SINGH VB,KUMAR S,et al.Immunogenicity and safety ofthe first indigenously developed Indian tetravalent influenza vaccine(split virion)in healthy adults≥18 years ofage:a randomized,multicenter,phase II/III clinical trial[J].Hum Vaccin Immunother,2018,20:1-23.
[4]吴金妍,柴文清,储艳,等.流感病毒裂解疫苗接种人体后的安全性和免疫原性观察[J].中国生物制品学杂志,2015,28(11):1173-1176.WU JY,CHAI WQ,CHU Y,e t a l.S a fe t y a n d immumogenicity ofinfluenza vaccine(split virion)in humans[J].Chinese Journal ofBiologicals,2015,28(11):1173-1176.
[5]HANQUET G,VANDAMME P,BRASSEUR D,et al.Lessons learnt from pandemic A(H1N1)2009 influenza vaccinat ion.Highl ights ofa European workshop in Brussels(22 March 2010)[J].Vaccine,2011,29(3):370.
[6]YANG Z,DONG Z,FU C.Seasonal influenza vaccine effectiveness among children aged 6 to 59 months in southern China[J].PLoS One,2012,7(1):e30424.
[7]Birgit Weinberger.Vaccines for the elderly:current use and future challenges[J].Immun Ageing,2018,15:3.
[8]戴宗祥,周健,蔡玮,等.季节性流行性感冒病毒裂解疫苗在小鼠中的安全性及免疫原性研究[J].中国疫苗和免疫,2012,18(6):508-510+554.DAI Zongxiang,ZHOU Jiang,CAI Wei,et al.Study ofsafety and immunogenicity oftrivalent seasonal influenza inactivated vaccine(split virion)in mouse[J].Chinese Journal ofVaccines and Immunization,2012,18(6):508-510+554.
[9]戴宗祥,王湘宜,王俊,等.流感病毒裂解疫苗儿童剂型在小鼠中的安全性及免疫原性研究[J].国际检验医学杂志,2012,33(15):1793-1794+1797.DAI ZX,WANG XY,WANG J,et al.Study ofsafety and immunogenicity ofsplit influenza vaccine for children dosage form in mouse[J].Internat ional Journal ofLaboratory Medicine,2012,33(15):1793-1794+1797.
[10]GAO JX,ZHAO YL,LIU JF,et al.Safety and effectiveness assessment of2011-2012 seasonal influenza vaccine produced in China:a randomized trial[J].Postgraduate Med,2017,129(8):907.
[11]PEPIN S,SZYMANSKI H,KOBASHI IAR,et al.Safety and immunogenicity ofan intramuscular quadrivalent influenza vaccine in children 3 to 8 years ofage:a phase III randomised cont rolled study[J].Human Vaccines Immun,2016,12(12):3072.
[12]GORSE GJ,FALSEY AR,OZOL-GODFREY A,et al.Safety and immunogenicity ofa quadrivalent intradermal influenza vaccine in adults[J].Vaccine,2015,33:1151.
[13]CLAEYS C,DRAME M,GARCíA-SICILIA J,et al.Assessment ofan optimized manufacturing process for inactivated quadrivalent influenza vaccine:a phase III,randomized,double-blind,safety and immunogenicity study in children and adults[J].BMC Infectious Diseases,2018,18(1):186.
[14]国家食品药品监督管理总局.疫苗临床试验技术指导原则[S].2007.China Food and Drug Administ ration.Guidelines for Vaccine Clinical Trials[S].2007.
[15]国家食品药品监督管理总局.化学药物和生物制品临床试验的生物统计学技术指导原则[S].2005.China Food and Drug Administ ration.Guidelines for biostat istics ofclinical t r ials ofchemical drugs and biological products[S].2005.
[16]WHO.Vaccines against influenza WHO position paperNovember 2012[J].Weekly Epidemiological Record,2012,87(47):461.
[17]European Committee for Proprietary Medical Produce.Note for guidance on harmonisation ofrequirements for influenza vaccine(CPMP/BWP/214/96)[S].1997-03.
[18]European Medicine Agency.Explanatory note on the withdrawal ofthe note for guidance on harmonisation ofrequirements for influenza vaccines and ofthe core SmPC/PL for inactivated seasonal influenza vaccines[S].2014-01-22.
[19]WHO FluNe t.I nfluenzala boratory surve illance information by the Global Influenza Survei l la nce a nd Response Sys t em(GISRS)[EB/OL].2014-05.http://gamapserver.who.int/gareports/Default.aspx?ReportNo=7.
[20]肖奇友,李放军,黄铭华,等.季节性灭活流行性感冒病毒裂解疫苗在老年人中的免疫原性及与甲型H1N1流行性感冒病毒的交叉免疫研究[J].中国疫苗和免疫,2011,17(2):139-142.XIAO QY,LI FJ,HUANG MH,et al.Immunogenicity oft r ivalent seasonal influenza vaccine(split vir ion)inactivated in elders and the cross-reactive immunity to novel influenza A(H1N1)virus[J].Chinese Journal ofVaccines and Immunization,2011,17(2):139-142.
[21]CHRISTOF DV,JOHANNA F,SEETHA M,e t a l.Immunogenicity and safety ofan inactivated 2012/2013trivalent influenza vaccine produced in mammalian cell culture(Optaflu?)an open label,uncontrolled study[J].Human Vaccines&Immunotherapeutics,2014,10(2):441-448.
[22]GORAN S,LIDIJA L,SVETLANA FV,et al.Safety and immunogenicity ofa seasonal trivalent inactivated split influenza vaccine:a phase I randomized clinical trial in healthy Serbian adults[J].Human Vaccines&Immunotherapeutics,2018,14(3):579-586.
[2]曾祥兴,李康生.流感百年:20世纪流感大流行的回顾与启示[J].医学与社会,2010,23(11):4-6.ZENG XX,LI KS.The pandemic history ofinfluenza:review and revelation ofthe influenza pandemic in last century[J].Medicine and Society,2010,23(11):4-6.
[3]SHARMA S,SINGH VB,KUMAR S,et al.Immunogenicity and safety ofthe first indigenously developed Indian tetravalent influenza vaccine(split virion)in healthy adults≥18 years ofage:a randomized,multicenter,phase II/III clinical trial[J].Hum Vaccin Immunother,2018,20:1-23.
[4]吴金妍,柴文清,储艳,等.流感病毒裂解疫苗接种人体后的安全性和免疫原性观察[J].中国生物制品学杂志,2015,28(11):1173-1176.WU JY,CHAI WQ,CHU Y,e t a l.S a fe t y a n d immumogenicity ofinfluenza vaccine(split virion)in humans[J].Chinese Journal ofBiologicals,2015,28(11):1173-1176.
[5]HANQUET G,VANDAMME P,BRASSEUR D,et al.Lessons learnt from pandemic A(H1N1)2009 influenza vaccinat ion.Highl ights ofa European workshop in Brussels(22 March 2010)[J].Vaccine,2011,29(3):370.
[6]YANG Z,DONG Z,FU C.Seasonal influenza vaccine effectiveness among children aged 6 to 59 months in southern China[J].PLoS One,2012,7(1):e30424.
[7]Birgit Weinberger.Vaccines for the elderly:current use and future challenges[J].Immun Ageing,2018,15:3.
[8]戴宗祥,周健,蔡玮,等.季节性流行性感冒病毒裂解疫苗在小鼠中的安全性及免疫原性研究[J].中国疫苗和免疫,2012,18(6):508-510+554.DAI Zongxiang,ZHOU Jiang,CAI Wei,et al.Study ofsafety and immunogenicity oftrivalent seasonal influenza inactivated vaccine(split virion)in mouse[J].Chinese Journal ofVaccines and Immunization,2012,18(6):508-510+554.
[9]戴宗祥,王湘宜,王俊,等.流感病毒裂解疫苗儿童剂型在小鼠中的安全性及免疫原性研究[J].国际检验医学杂志,2012,33(15):1793-1794+1797.DAI ZX,WANG XY,WANG J,et al.Study ofsafety and immunogenicity ofsplit influenza vaccine for children dosage form in mouse[J].Internat ional Journal ofLaboratory Medicine,2012,33(15):1793-1794+1797.
[10]GAO JX,ZHAO YL,LIU JF,et al.Safety and effectiveness assessment of2011-2012 seasonal influenza vaccine produced in China:a randomized trial[J].Postgraduate Med,2017,129(8):907.
[11]PEPIN S,SZYMANSKI H,KOBASHI IAR,et al.Safety and immunogenicity ofan intramuscular quadrivalent influenza vaccine in children 3 to 8 years ofage:a phase III randomised cont rolled study[J].Human Vaccines Immun,2016,12(12):3072.
[12]GORSE GJ,FALSEY AR,OZOL-GODFREY A,et al.Safety and immunogenicity ofa quadrivalent intradermal influenza vaccine in adults[J].Vaccine,2015,33:1151.
[13]CLAEYS C,DRAME M,GARCíA-SICILIA J,et al.Assessment ofan optimized manufacturing process for inactivated quadrivalent influenza vaccine:a phase III,randomized,double-blind,safety and immunogenicity study in children and adults[J].BMC Infectious Diseases,2018,18(1):186.
[14]国家食品药品监督管理总局.疫苗临床试验技术指导原则[S].2007.China Food and Drug Administ ration.Guidelines for Vaccine Clinical Trials[S].2007.
[15]国家食品药品监督管理总局.化学药物和生物制品临床试验的生物统计学技术指导原则[S].2005.China Food and Drug Administ ration.Guidelines for biostat istics ofclinical t r ials ofchemical drugs and biological products[S].2005.
[16]WHO.Vaccines against influenza WHO position paperNovember 2012[J].Weekly Epidemiological Record,2012,87(47):461.
[17]European Committee for Proprietary Medical Produce.Note for guidance on harmonisation ofrequirements for influenza vaccine(CPMP/BWP/214/96)[S].1997-03.
[18]European Medicine Agency.Explanatory note on the withdrawal ofthe note for guidance on harmonisation ofrequirements for influenza vaccines and ofthe core SmPC/PL for inactivated seasonal influenza vaccines[S].2014-01-22.
[19]WHO FluNe t.I nfluenzala boratory surve illance information by the Global Influenza Survei l la nce a nd Response Sys t em(GISRS)[EB/OL].2014-05.http://gamapserver.who.int/gareports/Default.aspx?ReportNo=7.
[20]肖奇友,李放军,黄铭华,等.季节性灭活流行性感冒病毒裂解疫苗在老年人中的免疫原性及与甲型H1N1流行性感冒病毒的交叉免疫研究[J].中国疫苗和免疫,2011,17(2):139-142.XIAO QY,LI FJ,HUANG MH,et al.Immunogenicity oft r ivalent seasonal influenza vaccine(split vir ion)inactivated in elders and the cross-reactive immunity to novel influenza A(H1N1)virus[J].Chinese Journal ofVaccines and Immunization,2011,17(2):139-142.
[21]CHRISTOF DV,JOHANNA F,SEETHA M,e t a l.Immunogenicity and safety ofan inactivated 2012/2013trivalent influenza vaccine produced in mammalian cell culture(Optaflu?)an open label,uncontrolled study[J].Human Vaccines&Immunotherapeutics,2014,10(2):441-448.
[22]GORAN S,LIDIJA L,SVETLANA FV,et al.Safety and immunogenicity ofa seasonal trivalent inactivated split influenza vaccine:a phase I randomized clinical trial in healthy Serbian adults[J].Human Vaccines&Immunotherapeutics,2018,14(3):579-586.