细菌多糖.ppt

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,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,),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,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,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,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.,Organization of the Laboratory of Bacterial Polysaccharides,Carl E.Frasch,Ph.D,Laboratory Chief,Pathogenic NeisseriaSection,Margaret C Bash,MD,Medical Officer,Lipopolysaccharide,Section,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,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,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.,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.,Research Objectives:,Lipopolysaccharide,Section,Conducts research to evaluate chemically or,genetically detoxified meningococcal,LPS bound to protein as a potential vaccine,for group B meningococcal disease.,Studies the genetics of LPS biosynthesis,in pathogenic and,commensal,Neisseria,species and characterizes their LPS immunochemically.,Thank you,