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1、细菌细菌(xjn)多糖多糖第一页,共12页。The Laboratory of Bacterial Polysaccharides ThemissionofthisLaboratoryisunifiedaroundthefactthat:Most all invasive bacterial diseases in the youngpediatric population are caused by bacterial specieshaving polysaccharide capsules:Haemophilus influenzae Neisseria meningitidisStre
2、ptococcus pneumoniaeStreptococcus agalactiae(GroupBStrep)第1页/共12页第二页,共12页。Licensed Vaccines for which the LBP has Product ResponsibilityPolysaccharides:Pneumococcal23-valentMerckMeningococcal4-valentAventisPasteurTyphoidViAventisPasteurConjugates:Haemophilusinfluenzaetypeb(Hib)WyethAventisPasteurMer
3、ck(2)Pneumococcal7-valentWyethCombination vaccines第2页/共12页第三页,共12页。Current Regulatory Activities in the Laboratory of Bacterial PolysaccharidesO IND supplement review over 125 active INDso Product License application and supplement review Over 80 submissions since June 2000o Meetings and conference
4、calls with manufacturerso Lot release protocol review and lot release testing Approximately 400 protocols per yearo Assist in training of reviewers and inspectorso Participate in inspections of manufacturing facilitieso Presentations to VRBPAC第3页/共12页第四页,共12页。Major outside mission related activities
5、 by Laboratory of BacterialPolysaccharides Personnel v Temporary consultants to CDC,PAHO,WHO and PATHv Help draft WHO requirements for conjugate vaccinesv Review Red Book chapters on polysaccharide and conjugate vaccinesv Journal review multiple journalsv Grant review for Meningitis Research Foundat
6、ionv Review of Military Infectious Disease Research Programv On organizing committees for major workshopsv Consult/train foreign laboratories in Quality Control第4页/共12页第五页,共12页。Research in the Laboratory of Bacterial PolysaccharidesResearch in the Laboratory of Bacterial Polysaccharides TheLBPisresp
7、onsiblefor:TheLBPisresponsiblefor:ConductingbasicandappliedresearchonproblemsrelatedtoConductingbasicandappliedresearchonproblemsrelatedtothepreparation,purity,stability,andimmunogenicityofthepreparation,purity,stability,andimmunogenicityofinvestigationalandlicensedvaccinesforencapsulatedbacterialin
8、vestigationalandlicensedvaccinesforencapsulatedbacterialpathogens.pathogens.Evaluatinghost-parasiteinteractionsforpathogenesisandEvaluatinghost-parasiteinteractionsforpathogenesisandprotectiveimmunity.protectiveimmunity.第5页/共12页第六页,共12页。Organization of the Laboratory of Bacterial PolysaccharidesCarl
9、 E.Frasch,Ph.DLaboratory ChiefPathogenic NeisseriaSectionMargaret C Bash,MDMedical OfficerLipopolysaccharideSectionChao-Ming Tsai,Ph.D.BiochemistPolysaccharide and ConjugateVaccine QC Lot ReleaseChi-Jen Lee,Sc.D.BiochemistPolysaccharide ImmunitySectionCarl E.Frasch,Ph.DMicrobiologistCellular Immunol
10、ogySectionMustafa Akkoyunlu,MD,Ph.D.Immunologist第6页/共12页第七页,共12页。Research Objectives:Polysaccharide Immunity SectionConductsresearchtoevaluatetheabilityofpolysaccharideandconjugatevaccinestoinduceprotectiveimmunity.Studiesdifferentconjugationchemistriestoimproveconjugateyieldsandtoimprovetheimmunere
11、sponsetonativepolysaccharideepitopes第7页/共12页第八页,共12页。Research Objectives:Cellular Immunity SectionFocusesontheinitialphaseofpolysaccharidevaccine/encapsulatedbacteriainteractionwithhostimmunity.Seekstodefinetheinteractionofpolysaccharideswithtoll-likereceptors(TLRs)oninnatecells.Thebiologicaleventsr
12、esultingfromthisinteractionmayaffectthedevelopmentofadaptiveimmuneresponsesagainstpolysaccharides.Investigatestheroleof“Aproliferation-inducingligand”(APRIL)andBLymphocyteStimulator(BLyS)ininfantandadultimmuneresponsesagainstbacterialpolysaccharides.第8页/共12页第九页,共12页。Research Objectives:Pathogenic Ne
13、isseria SectionInvestigates the Por B proteins of Neisseria gonorrhoeae and Neisseria meningitidis.StudiesthenaturalepidemiologyofPorvariationusingnovelmoleculartypingmethodsEvaluatestheeffectsofPorvariationonhost-pathogeninteractionincludingimmuneresponsestoPor,structurefunctionrestrictionsonPor,an
14、dtransmissionpatternsIdentifiesthemechanismsofPorvariationthroughinvestigationofmixedinfections,diverseandclonalpopulations.第9页/共12页第十页,共12页。Research Objectives:Lipopolysaccharide SectionConductsresearchtoevaluatechemicallyorgeneticallydetoxifiedmeningococcalLPSboundtoproteinasapotentialvaccineforgroupBmeningococcaldisease.StudiesthegeneticsofLPSbiosynthesisinpathogenicandcommensalNeisseriaspeciesandcharacterizestheirLPSimmunochemically.第10页/共12页第十一页,共12页。Thank you第11页/共12页第十二页,共12页。