November 28–29, 2012

International Workshop on Alternatives to the Murine Histamine Sensitization Test (HIST) for Acellular Pertussis Vaccines: State of the Science and the Path Forward

International Workshop on Alternatives to the Murine Histamine Sensitization Test (HIST) for Acellular Pertussis Vaccines: State of the Science and the Path Forward Final Documents

November 28–29, 2012

• Workshop Report (Biologicals)
• Workshop Summary

International Workshop on Alternatives to the Murine Histamine Sensitization Test (HIST) for Acellular Pertussis Vaccines: State of the Science and the Path Forward Presentations

November 28–29, 2012

Opening Session

• Welcoming Remarks and Introduction to ICCVAM and ICATM Organizations
  William Stokes, DVM, RADM, USPHS, NIEHS/NICEATM
  Karen Midthun, MD; Director, Center for Biologics Evaluation and Research (CBER), U.S. FDA
• Workshop Introduction and Objectives
  Juan Arciniega, DSc, CBER, U.S. FDA
• Plenary Presentation: The Many Faces of Pertussis Toxin
  Nicholas Carbonetti, PhD, University of Maryland Medical School, USA
• Current Regulatory Requirements for Residual Pertussis Toxin Testing of Acellular Vaccines
  Sue Nelson, PhD, Sanofi Pasteur, Canada
• International Collaborative Study on Validation of an In Vitro Assay System as an Alternative to the Current Histamine Sensitization Test for Acellular Pertussis Vaccines
  Dorothy Xing, PhD, National Institute for Biological Standards and Control (NIBSC), United Kingdom
• Overview of the International Working Group for Alternatives to HIST (Phase 1)
  Richard Isbrucker, PhD, Health Canada

Session 1: Alternatives to HIST: Methods and Evaluations: Reports on Alternative Methods to HIST and Results Using Pertussis Toxin-Spiked Vaccine Samples

Biochemical Assays: Carbohydrate-Binding Assay; Enzymatic/HPLC Assays

• Analyses of Pertussis Toxin ADP-ribosyltransferase and Carbohydrate-Binding Activities as an In Vitro Alternative to the In Vivo HIST
  CT Yuen, PhD, NIBSC, United Kingdom
• In Vitro Assays for the Detection of Pertussis Toxin: BSP114 Collaborative Study Results
  Amélie Castiaux, Ir, GlaxoSmithKline, Belgium
• Alternative In Vitro Methods for Detection of Pertussis Toxin in Component Pertussis Vaccines: Results of a BSP114 Phase 1 International Collaborative Study
  Juthika Menon, PhD, Sanofi Pasteur, Canad
• Characteristics of Enzymatic and Binding Activities of Pertussis Toxin According to Chemical Detoxifying Agents
  Hokyung Oh, PhD, Korea Food and Drug Administration, Republic of Korea

Biochemical and Cell-Based Assays: Carbohydrate-Binding Assay, Enzymatic/HPLC Assays, CHO Cell Clustering Assay

• Detection of PTx in Acellular Pertussis Vaccines Using a CHO Cell Clustering Assay, a Carbohydrate-Binding Assay, and an Enzymatic/HPLC Assay
  Richard Isbrucker, PhD, Health Canada
• Cell-Based Assays for Detection of Pertussis Toxin in Acellular Vaccines: The cAMP-PTx Assay and the Pertussis ATP Test (PAT)
  Christina Bache, PhD, Paul-Ehrlich-Institut, Germany
  Marieke Hoonakker, MSc, Netherlands Vaccine Institute, The Netherlands

Genetic Assays: Differential Gene Expression in Monocyte-Derived Dendritic Cells

• Using Pertussis Toxin-Sensitive Genes in Dendritic Cells to Evaluate the Safety of Acellular Pertussis Vaccines
  Stefan F.C. Vaessen, PhD, University of Applied Sciences Utrecht, The Netherlands
• Summary Analysis of Reported Data Sets
  Lev Sirota, PhD, CBER, U.S. FDA

Session 2: The Path Forward: Gaps to Cross and Bridges to Build in the Road Toward the Adoption of Alternatives to HIST

• Opening Remarks
  Richard Isbrucker, PhD, Health Canad
• Plenary Presentation: Pertussis Toxin and the CHO Cell Response
  Erik L. Hewlett, MD, University of Virginia School of Medicine, USA