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1、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 meningitidisStreptococcus pneumoniaeSt
2、reptococcus agalactiae(GroupBStrep)第1页/共12页Licensed Vaccines for which the LBP has Product ResponsibilityPolysaccharides:Pneumococcal23-valentMerckMeningococcal4-valentAventisPasteurTyphoidViAventisPasteurConjugates:Haemophilusinfluenzaetypeb(Hib)WyethAventisPasteurMerck(2)Pneumococcal7-valentWyethC
3、ombination vaccines第2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 calls with manufacturerso Lot release pr
4、otocol 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Major outside mission related activities by Laboratory of BacterialPolysaccharides Person
5、nel 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 Foundationv Review of Military Infectious Disease Resear
6、ch Programv On organizing committees for major workshopsv Consult/train foreign laboratories in Quality Control第4页/共12页Research in the Laboratory of Bacterial Polysaccharides TheLBPisresponsiblefor:Conductingbasicandappliedresearchonproblemsrelatedtothepreparation,purity,stability,andimmunogenicityo
7、finvestigationalandlicensedvaccinesforencapsulatedbacterialpathogens.Evaluatinghost-parasiteinteractionsforpathogenesisandprotectiveimmunity.第5页/共12页Organization of the Laboratory of Bacterial PolysaccharidesCarl E.Frasch,Ph.DLaboratory ChiefPathogenic NeisseriaSectionMargaret C Bash,MDMedical Offic
8、erLipopolysaccharideSectionChao-Ming Tsai,Ph.D.BiochemistPolysaccharide and ConjugateVaccine QC Lot ReleaseChi-Jen Lee,Sc.D.BiochemistPolysaccharide ImmunitySectionCarl E.Frasch,Ph.DMicrobiologistCellular ImmunologySectionMustafa Akkoyunlu,MD,Ph.D.Immunologist第6页/共12页Research Objectives:Polysacchari
9、de Immunity SectionConductsresearchtoevaluatetheabilityofpolysaccharideandconjugatevaccinestoinduceprotectiveimmunity.Studiesdifferentconjugationchemistriestoimproveconjugateyieldsandtoimprovetheimmuneresponsetonativepolysaccharideepitopes第7页/共12页Research Objectives:Cellular Immunity SectionFocuseso
10、ntheinitialphaseofpolysaccharidevaccine/encapsulatedbacteriainteractionwithhostimmunity.Seekstodefinetheinteractionofpolysaccharideswithtoll-likereceptors(TLRs)oninnatecells.Thebiologicaleventsresultingfromthisinteractionmayaffectthedevelopmentofadaptiveimmuneresponsesagainstpolysaccharides.Investig
11、atestheroleof“Aproliferation-inducingligand”(APRIL)andBLymphocyteStimulator(BLyS)ininfantandadultimmuneresponsesagainstbacterialpolysaccharides.第8页/共12页Research Objectives:Pathogenic Neisseria SectionInvestigates the Por B proteins of Neisseria gonorrhoeae and Neisseria meningitidis.Studiesthenatura
12、lepidemiologyofPorvariationusingnovelmoleculartypingmethodsEvaluatestheeffectsofPorvariationonhost-pathogeninteractionincludingimmuneresponsestoPor,structurefunctionrestrictionsonPor,andtransmissionpatternsIdentifiesthemechanismsofPorvariationthroughinvestigationofmixedinfections,diverseandclonalpop
13、ulations.第9页/共12页Research Objectives:Lipopolysaccharide SectionConductsresearchtoevaluatechemicallyorgeneticallydetoxifiedmeningococcalLPSboundtoproteinasapotentialvaccineforgroupBmeningococcaldisease.StudiesthegeneticsofLPSbiosynthesisinpathogenicandcommensalNeisseriaspeciesandcharacterizestheirLPSimmunochemically.第10页/共12页 Thank you第11页/共12页感谢您的观看!第12页/共12页