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Laboratory of Bacterial

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 young
     pediatric population are caused by bacterial species
     having polysaccharide capsules:

                  • Haemophilus influenzae
                  • Neisseria meningitidis
                  • Streptococcus pneumoniae
                  • Streptococcus agalactiae (Group B Strep)
    Licensed Vaccines for which the LBP has
             Product Responsibility
     • Pneumococcal 23-valent          Merck
     • Meningococcal 4-valent          Aventis Pasteur
     • Typhoid Vi                     Aventis Pasteur

     • 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
o Product License application and supplement review
       Over 80 submissions since June 2000
o Meetings and conference calls with manufacturers
o Lot release protocol review and lot release testing
        Approximately 400 protocols per year
o Assist in training of reviewers and inspectors
o Participate in inspections of manufacturing facilities
o Presentations to VRBPAC
      Major outside mission related
    activities by Laboratory of Bacterial
        Polysaccharides 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
  Polysaccharide Immunity
                                 Laboratory Chief
    Carl E. Frasch, Ph.D

                    Cellular Immunology
                Mustafa Akkoyunlu, MD, Ph.D.

                                 Pathogenic Neisseria
                                 Margaret C Bash, MD
                                    Medical Officer

                                               Chao-Ming Tsai, Ph.D.

                                                      Polysaccharide and Conjugate
                                                         Vaccine QC Lot Release
                                                           Chi-Jen Lee, Sc.D.
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

 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
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

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