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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 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 menin

2、gitidis Streptococcus pneumoniae Streptococcus agalactiae (Group B Strep)第1页/共12页第二页,共12页。Licensed Vaccines for which the LBP has Product ResponsibilityPolysaccharides: Pneumococcal 23-valent Merck Meningococcal 4-valent Aventis Pasteur Typhoid Vi Aventis PasteurConjugates: Haemophilus influenzae ty

3、pe b (Hib) Wyeth Aventis Pasteur Merck (2 ) Pneumococcal 7-valent WyethCombination 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

4、since June 2000o Meetings and conference 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

5、。Major outside mission related activities 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 G

6、rant review for Meningitis Research Foundationv 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。第5页/共12页第六页,共12页。Organization of the Laboratory of Bacterial PolysaccharidesCarl

7、 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

8、ImmunologySectionMustafa Akkoyunlu, MD, Ph.D.Immunologist第6页/共12页第七页,共12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 conjug

9、ate yields and to improve the immune response to native polysaccharide epitopes第7页/共12页第八页,共12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 polysaccharid

10、es 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 a

11、nd adult immune responses against bacterial polysaccharides. 第8页/共12页第九页,共12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

12、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9页/共12页第十页,共12页。Research Objectives: Lipopolysaccharide Section Conducts research to evaluate chemically or genetically detoxified meningococcal LPS bound to protein as a potential vaccine for group B menin

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