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Co-relation Analysis On Antibody Reaction In Population Immunized With EV71 Inactived Vaccine,Live Poliomyelitis And Live HAV Vaccine

Posted on:2018-07-20Degree:MasterType:Thesis
Country:ChinaCandidate:J LiFull Text:PDF
GTID:2334330518462643Subject:Biological products
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Enterovirus 71(EV71)is one of the main pathogens for cuasing hand,foot and mouth disease(HFMD).In the past few years,the prevalence of HFMD has become one of the most important public health issues in the mainland China,Taiwan,and some other countries in the Southeast Asia,causing large economic losses and burden on society.Previous studies showed that EV71 was a major cause severe HFMD cases and fatal cases.There is no efficient therapeutic measures for HFMD at present.Development of an effective vaccine is the most effective ways to prevent and control the prevalence of HFMD.The increasing incidence and mortality of HFMD caused by EV71 promotes the development of EV71 vaccine.The EV71 vaccine development study takes eight years.The enterovirus 71 inactivated vaccine developed by Chinese Academy of Medical Sciences(CAMS)has been market in mainland China for school-age children.For the requirement of CFDA vaccine registration,in order to systematically investigate the safety?immunogenicity and protective effect of post-marketing EV71 inactived vaccine,since September 2016,muti-center clinical trail study was sponsored by CAMS,the clinical research centers including Chaoyang District,Beijing;Xiangyang District of Hubei Province;Arong banner of inner mongolia;Zhejiang Province,etc.Because the children in age group of 6 months~5 years old is the main recipients of a variety of vaccine listed in EPI,The relationship between the specific immune reaction of EV71-induced and other vaccine immune reaction is obviously a problem of epidemiological significance.In the phase ? clinical study of post-markting EV71 inactivated vaccine in Arong banner of inner mongolia.Besides of the observetion the safety and immunogenicity of the vaccine,the study particularly focus on immune responsing of live attenuated hepatitis A(HAV)vaccine and oral poliovirus(PV)vaccine which all belong to Enterovirus.The research studied on serum samples collected from the subjects immunized with inactivated EV71 vaccine.Neutralizing antibody(NTAb)against EV71 and poliovirus were detected by micro-cytopathic effect neutralization test.ELISA was used to detect IgG antibody against HAV.The relationship of anti-poliovirus neutralizing antibody?anti-EV71 neutralizing antibody and anti-hepatitis A virus IgG antibody was observed in this study to evaluate whether the pre-exist immune response caused by other vaccines were be influence by EV71 inactived vaccine.The results showed that the EV71 inactivated vaccine was safe in children aged 24~71 months.Fever was the most common systemic reactions.pain,red was the most common local reaction.No serious adverse events were observed,EV71 inactivated vaccine shows good immunogenicity following the prescribed immunization procedure and dose.The anti-EV71 neutralizing antibody positive rate was 97.72%,the geometric mean titers(GMTs)of anti-EV71 neutralizing antibody increased to 64.37 following the two-dose injection of inactivated EV71 vaccine.The result of study also showed that the antibody induced by the EV71 vaccine has no impact on the anti-HAV IgG antibody pre-exist in children.Moreover,the anti-HAV IgG level during the two-dose EV71 vaccination period has no correlation with anti-EV71 NTAb producing(|r|<0.1).However,our observation suggested that the anti-poliovirus I?II?III were interfered slightly by EV71 vaccination(p<0.05).A decreasing antibody titer of anti-poliovirus(types ???)at 28 days after the first dose of EV71 vaccine was observed could be a relativity with anti-EV71 NTAb increasing(|r| =0.3).For the type I poliovirus NTAb(28 days after first dose of EV71)and all three types of poliovirus NTAb(28 days after second dose of EV71),we didn' t find significant correlation with anti-EV71 NTAb(|r|?0.1),implying that these changes of antibody profile do not affect the clinical efficiency of immune response to live attenuated hepatitis A vaccine and Poliomyelitis Vaccine Live.Our finding supported the potential of EV71 vaccine being listed into EPI program and the fessibility for developing the combined vaccine.
Keywords/Search Tags:Enterovirus Type 71 Vaccine, Inactived(Human Diploid Cell), Phase ? clinical trail, Immunogenicity, Safety, Antibody, Dynamic monitor, Correlation analysis
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