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Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,*,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,Overview Laboratory of Bacterial,Polysaccharides,From cover-Science,23 March,2001,第一页，共十三页。,The Laboratory of Bacterial Polysaccharides,The mission of this Laboratory is unified around the fact that:,Most all invasive bacterial diseases in the youngpediatric population are caused by bacterial specieshaving polysaccharide capsules:,Haemophilus influenzae,Neisseria meningitidis,Streptococcus pneumoniae,Streptococcus agalactiae,(Group B Strep),第二页，共十三页。,Licensed Vaccines,for which the LBP has Product Responsibility,Polysaccharides:,Pneumococcal 23-valent Merck,Meningococcal 4-valent Aventis Pasteur,Typhoid Vi Aventis Pasteur,Conjugates:,Haemophilus influenzae type b(Hib)Wyeth Aventis Pasteur Merck(2),Pneumococcal 7-valent Wyeth,Combination vaccines,第三页，共十三页。,Current Regulatory Activities in the Laboratory of Bacterial Polysaccharides,O,IND supplement review,over 125 active INDs,Product License application and supplement review,Over 80 submissions since June 2000,Meetings and conference calls with manufacturers,Lot release protocol review and lot release testing,Approximately 400 protocols per year,Assist in training of reviewers and inspectors,Participate in inspections of manufacturing facilities,Presentations to VRBPAC,第四页，共十三页。,Major outside mission related activities by Laboratory of BacterialPolysaccharides Personnel,Temporary consultants to CDC,PAHO,WHO and PATH,Help draft WHO requirements for conjugate vaccines,Review Red Book chapters on polysaccharide and conjugate vaccines,Journal review multiple journals,Grant review for Meningitis Research Foundation,Review of Military Infectious Disease Research Program,On organizing committees for major workshops,Consult/train foreign laboratories in Quality Control,第五页，共十三页。,Research in the Laboratory of Bacterial Polysaccharides,The LBP is responsible for:,Conducting basic and applied research on problems related to the preparation,purity,stability,and immunogenicity of investigational and licensed vaccines for encapsulated bacterial pathogens.,Evaluating host-parasite interactions for pathogenesis and protective immunity.,第六页，共十三页。,Organization of the Laboratory of Bacterial Polysaccharides,Carl E.Frasch,Ph.D,Laboratory Chief,Pathogenic NeisseriaSection,Margaret C Bash,MD,Medical Officer,LipopolysaccharideSection,Chao-Ming Tsai,Ph.D.,Biochemist,Polysaccharide and Conjugate,Vaccine QC Lot Release,Chi-Jen Lee,Sc.D,.,Biochemist,Polysaccharide ImmunitySection,Carl E.Frasch,Ph.D,Microbiologist,Cellular ImmunologySection,Mustafa Akkoyunlu,MD,Ph.D,.,Immunologist,第七页，共十三页。,Research Objectives:,Polysaccharide Immunity Section,Conducts research to evaluate the ability of polysaccharide and conjugate vaccines to induce protective immunity.,Studies different conjugation chemistries to improve conjugate yields and to improve the immune response to native polysaccharide epitopes,第八页，共十三页。,Research Objectives:,Cellular Immunity Section,Focuses on the initial phase of polysaccharide vaccine/encapsulated bacteria interaction with host immunity.,Seeks to define the interaction of polysaccharides with toll-like receptors(TLRs)on innate cells.The biological events resulting from this interaction may affect the development of adaptive immune responses against polysaccharides.,Investigates the role of“A proliferation-inducing ligand”(APRIL)and B Lymphocyte Stimulator(BLyS)in infant and adult immune responses against bacterial polysaccharides.,第九页，共十三页。,Research Objectives:,Pathogenic Neisseria Section,Investigates the Por B proteins of Neisseria gonorrhoeae and Neisseria meningitidis.,Studies the natural epidemiology of Por variation using novel molecular typing methods,Evaluates the effects of Por variation on host-pathogen interaction including immune responses to Por,structure function restrictions on Por,and transmission patterns,Identifies the mechanisms of Por variation through investigation of mixed infections,diverse and clonal populations.,第十页，共十三页。,ResearchObjectives:,LipopolysaccharideSection,ConductsresearchtoevaluatechemicallyorgeneticallydetoxifiedmeningococcalLPSboundtoproteinasapotentialvaccineforgroupBmeningococcaldisease.,StudiesthegeneticsofLPSbiosynthesisinpathogenicandcommensal,Neisseria,speciesandcharacterizestheirLPSimmunochemically.,第十,一,一页,，,，共,十,十三,页,页。,Thankyou,第十,二,二页,，,，共,十,十三,页,页。,内容,(n,irng),总结,OverviewLaboratoryofBacterial。PresentationstoVRBPAC。Chi-JenLee,Sc.D.,。,。Thankyou,第十,三,三页,，,，共,十,十三,页,页。,