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Overview of Laboratory of Bacterial Polysaccharides

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Title: Overview of Laboratory of Bacterial Polysaccharides Author: FDA User Last modified by: Brownj Created Date: 11/20/2006 9:40:22 PM Document presentation format – PowerPoint PPT presentation

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Title: Overview of Laboratory of Bacterial Polysaccharides


1
Overview of Laboratory of Bacterial
Polysaccharides
  • By
  • Willie F. Vann, Chief LBP

2
Description of the Laboratory of Bacterial
Polysaccharides
  • The Laboratory of Bacterial Polysaccharides
    investigates the biochemistry, biology,
    chemistry, and immunology of virulence factors of
    encapsulated bacteria.
  • These virulence factors include capsular
    polysaccharides, lipopolysaccharides, and outer
    membrane proteins.

3
Description of the Laboratory of Bacterial
Polysaccharides (continued)
  • The Laboratory of Bacterial Polysaccharides has
    review responsibility for submissions related to
    polysaccharide and polysaccharide conjugate
    vaccines in addition to non-capsular immunogens
    of encapsulated pathogens.

4
Chronology of Laboratory of Bacterial
Polysaccharides
  • 2002
  • Last Site Visit
  • 2004
  • CE Frasch steps down as Lab Chief
  • MS Blake becomes Acting Lab Chief
  • 2006
  • WF Vann appointed Lab Chief
  • Glycobiology Group of Lab of Bacterial Toxins
    joined Lab of Bacterial Polysaccharides
  • NMR and Mass Spectrometry groups of Lab of
    Biophysics joined Lab of Bacterial Polysaccharides

5
Current Organization of the Laboratory of
Bacterial Polysaccharides
6
CURRENT RESEARCH STAFF
7
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8
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9
Areas of Research
  • Structure and conformation of capsular
    polysaccharides
  • Biosynthesis of capsular polysaccharides
  • Role of non-capsular antigens in protection
  • Interaction of the capsular polysaccharides with
    the immune system
  • Development of methodology for analysis of
    conjugate vaccines

10
Relevance of Research Program to CBER Mission
  • The Laboratory of Bacterial Polysaccharides has
    regulatory responsibility for vaccines against
    encapsulated bacteria and products containing
    bacterial polysaccharides
  • The overall goal of the research program of the
    LBP is to understand the virulence factors that
    are components of vaccines against bacterial
    pathogens.

11
Relevance of Research Program to CBER Mission
(continued)
  • The research program of the Laboratory of
    Bacterial Polysaccharides is directed toward
    understanding the physical, chemical, and
    immunological properties of bacterial
    polysaccharides, and polysaccharide conjugate
    vaccines
  • The knowledge and expertise gained in this
    research endeavor provide a scientific basis for
    our decisions related to the review of
    manufacturing, purity, potency, and safety of
    carbohydrate containing vaccines.

12
Some Significant Achievements
  • Development of Efficient Method for Meningococcal
    Group A Conjugate Vaccine Synthesis
  • Vaccine in MVP/WHO Sponsored Phase II Clinical
    Trial

13
Meningococcal Group A Conjugate Vaccine
Projectmanaged by CE Frasch - CBER M. LaForce
MVP
Gates Foundation
Daron Freedberg and Scott Norris contributed to
analysis during development
14
Some Significant AchievementsAnalytical
Biochemistry ChaoMing Tsai, PI
  • Developed HPAEC method for quantitation of
    phosphate and acetylation in polysaccharide
    vaccines
  • Characterized the lgtH gene of Neisseria LOS gene
    cluster
  • Demonstrated that the LOS of commensal N.
    polysaccharea is similar to LOS of meningococcal
    pathogen

15
Some Significant AchievementsMolecular
Epidemiology Margaret Bash
  • Developed and applied molecular methods to study
    PorB diversity
  • Horizontal genetic exchange (mosaicism)
    predominates
  • Persistence of PorB variable region sequence
    types indicates diversification is constrained
  • Identified survival advantages associated with
    PorB types
  • Relevant to development and evaluation of broadly
    protective OMP vaccines

16
Some Significant AchievementsCellular
Immunology-Mustafa Akkoyunlu, PI
  • Interactions of bacterial capsular
    polysaccharides with innate immune system.
  • Neisseria meningitidis type C polysaccharide
    binding to CD14 and LBP inhibits meningococcal
    LPS mediated cell activation
  • Modulation of BAFF/APRIL system molecules by
    microbial products.
  • Decreased expression of TACI on newborn mouse B
    cells may to be responsible for the impaired
    response of newborns to polysaccharide antigens.
  • Toll-like receptor agonists, CpG DNA and LPS,
    strongly upregulate TACI expression on B cells.

17
Some Significant Achievements Structural
Biology-Daron Freedberg, PI
  • 1. On cell NMR In-vivo antigen characterization
    by NMR
  • Mening B PS structure on cells Mening B PS
    structure in vaccine

mmonomer ppolymer
2. Carbohydrate 3D Structure Sucrose
18
Licensed Product Responsibility
Vaccine Class Product Manufacturer
Polysaccharide Pneumococcal 23-valent Wyeth
Merck
Meningococcal tetravalent Sanofi Pasteur
Typhoid Vi Sanofi Pasteur

Conjugate Haemophilus influenzae type b Wyeth
Sanofi Pasteur
Merck (2)
Pneumococcal heptavalent Wyeth
Meningococcal tetravalent Sanofi Pasteur

19
Regulatory Responsibilities
20
Regulatory Accomplishments
  • Licensing Tetravalent Meningococcal Conjugate
    Diphtheria Toxoid Vaccine against groups A,C,
    Y, and W-135
  • Reviewers included Frasch, Tsai, Lee, Bash, Lynn,
    Blake
  • Significant Changes in Analytical Methodology for
    Lot Release
  • Reviewers included Tsai, Freedberg

21
Other Regulatory Accomplishments
  • IND Supplement Reviewed 350
  • BLA BLA Supplement Review -85
  • Participated in International and CBER Policy
    Working Groups
  • Distributed Reference Material for Haemophilus
    and Pneumococcal Antibody Assays
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