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Smallpox and Influenza

Smallpox and Influenza.

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Smallpox and Influenza

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  1. Smallpox and Influenza "In early 1962 long queues attended any clinic in Birmingham offering vaccination, because three patients with smallpox were in the isolation hospital. At this time over 100 people a week were dying in Birmingham of … (influenza) … ; but this caused no great public agitation." T. H. Flewett Introduction to 'Symposium on Influenza in Hospital and Elsewhere'. Postgrad Med J 1963: 39: 563.

  2. IOM Pandemic Flu Meeting: working group 6 Specific Questions: 1) What research is needed to develop/ assess new vaccine production and clinical trial strategies 2) What research is needed to define the potential for common antigen vaccines against all Flu including avian influenza strains? 3) What studies are needed to identify/ study adjuvants that can provide antigen-sparing effects for Flu vaccines? 4) What studies are needed to assess ID/TD/IN administration as an immunogenicity enhancing/ antigen sparing measure? 5) What research is needed to develop/ assess new devices/ strategies for vaccine administration ID/TD/IN ? 6) What studies are needed to assess the feasibility of novel vaccines (conserved proteins, etc..) for pandemic influenza preparedness?

  3. Improve Production ( Question 1) IOM Pandemic Flu Research Meeting – Working Group 6 A. Cell substrate for production of existing vaccines 1. What is current best (eggs vs. cells)? Do we know which cells? 2. What is future best (eggs vs. cells)? How do we determine? 3. Is it possible to be prepared with egg based production? 4. If current best cells are PER.C6 or MDCK, what are research needs? B. Improve Growth yield of existing flu vaccine 1. Via increased viral growth (reassortants/ reverse genetics/other)? C.) Rapidly identify the appropriate flu isolate for use in pandemic vaccine 1. Substrate used for isolation (cell/eggs/reverse genetics/fujian issues) 2. Ensure high yield of vaccine (reverse genetics, other) 3. Manufacturing safety (reverse genetics, other)

  4. Improve Immunogenicity (Questions 2,3,4,5) IOM Pandemic Flu Research Meeting – Working Group 6 A. Increased Potency of Existing or New Vaccines (not hetersubtypic) 1. Adjuvant ( MF59, alum, others)- How to design/ choose new adjuvants? 2. Alternate routes (ID, TD, IN), new delivery devices, other – What’s needed? 3. Alternate formulation of existing vaccines: WC/ Split Product/ Subunit 4. Alternative existing vaccine types – TIV vs. CAIV – Is one more immunogenic in the immuno-naive setting? B. Increased Heterosubtypic Potency of New or Existing Vaccine 1. What is basis and molecular mechanism for cross reactivity? 2. CAIV vs. TIV- are they different, if so, why? 3. Common Antigen (M2, other), is this approach feasible? 4.T Cell Immunity vs. Antibody to HA/NA. Is T cell approach feasible? 5. Pre-prime pop. with heterosubtypic H5/H9/etc. Advantages vs. problems C. Speed of Onset 1. One dose vs. 2 or 3 doses (TIV/ CAIV/other)- is this different than potency?

  5. Totally New Flu Vaccines (Question 6) IOM Pandemic Flu Research Meeting – Working Group 6 Expressed Flu Proteins Administered as Proteins or Peptides (HA/NA/M2) – Protein Folding/ Peptide Immunogenicity problems B. Expressed Flu Proteins Administered as DNA – How to Improve? C. Expressed Flu Proteins Administered via Viral/Bacterial Vectors Which Vector / Route? Pandemic specific vs. general approach? D. Other?

  6. Improve Clinical Evaluation of Existing/ New Vaccines (Question 1) IOM Pandemic Flu Research Meeting – Working Group 6 Can we develop informative human challenge models for pandemic flu? Are there methods to compare distinct candidates head to head, if not? How to evaluate safety/ reactogenicity/ immunogenicity for a pandemic candidate? Are criteria the same or different? When do we need to move testing to infants /elderly in the evaluation?

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