Overview Laboratory of Bacterial Polysaccharides
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Transcript of Overview Laboratory of Bacterial Polysaccharides
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
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.DLaboratory Chief
Pathogenic NeisseriaSection
Margaret C Bash, MDMedical Officer
LipopolysaccharideSection
Chao-Ming Tsai, Ph.D.Biochemist
Polysaccharide and ConjugateVaccine QC Lot Release
Chi-Jen Lee, Sc.D.Biochemist
Polysaccharide ImmunitySection
Carl E. Frasch, Ph.DMicrobiologist
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