HPV Serology Standardization Meeting (Agenda)

Session I: HPV Serology Standardization Efforts: An Update
Chair: Elizabeth Unger, CDC

Objectives:

• Provide updates on HPV Standards for the 9 HPV types of interest
• Describe availability and implementation approaches of International Standards, as well as other key reagents for HPV serology
• Identify other key reagents in standardization

Introduction to the Session
Elizabeth Unger, CDC

HPV Serology Standardization Initiative at FNLCR: An update
Ligia Pinto, FNLCR

WHO International Standards (IS) for HPV serology: Recent development and implementation plans
Dianna Wilkinson, National Institute for Biological Standards and Control (NIBSC)

Q&A

Facilitated Discussion #1 (Moderator: Dianna Wilkinson, NIBSC)

• Standards implementation
• Reporting results in International Units (IU) – methods and consensus on best practices
• Neutralization assays standardization and reporting in IU
• Calibration to International Standards procedure
• Other reagents needed for standardization

Session II: Developments and Challenges in HPV Serology Assays
Chair: Ligia Pinto, FNLCR

Objectives:

• Review recent serology assay developments to evaluate immunogenicity of current and next generation vaccines
• Describe availability and implementation approaches of International Standards, as well as other key reagents for HPV serology
• Discuss approaches to determine assay cut-off values

Introduction to the Session
Ligia Pinto, FNLCR

HPV serology multiplex assays at FNLCR: An update on development and validation
Troy Kemp, FNLCR

Serology assays for L2-based HPV vaccines
Richard Roden, Johns Hopkins University

Observations on use of children’s sera to establish assay cut-off
Gitika Panicker, CDC

Q&A

Facilitated discussion #2 (Moderator: Elizabeth Unger, CDC)

• Definition of cut-off value
• Can cut-off values be established in IU/ml and harmonized?
• Interlaboratory comparisons for establishing cut-off value
• New questions raised by new assays

Development of high-throughput assay for HPV neutralizing antibodies
Jianhui Nie, National Institutes for Food and Drug Control

Anti-HPV Monoclonal Antibodies: A key resource for Serology Assay QC
Neil Christensen, Penn State University

Q&A

Objectives:

• Review of assays used or planned to be used in HPV vaccine trials and immunobridging studies
• Review of progress of ongoing one dose HPV vaccine trials
• Neutralization assays standardization and reporting in IU
• Discuss standardization and data analyses plans

Introduction to the Session
Joakim Dillner, KI

HPV serology testing in Merck vaccine studies: Recent developments and observations
Alfred Saah, Merck & Co., Inc.

HPV Serology Assays: A collaborative approach for implementation
Aparna Kasinath, Syngene International Limited

One dose immunobridging trials: Review of study portfolio progress and plans for harmonization of analyses
Anne Schuind, PATH

DORIS Study: Review of immunobridging plans and preliminary data
Deborah Watson-Jones and Kathy Baisley, LSHTM

Immunogenicity of a prime and deferred-booster dosing schedule: Preliminary review of results
Vikrant Sahasrabuddhe, National Cancer Institute

KEN-SHE study: Planned Antibody Testing
Denise Galloway, Fred Hutchinson Cancer Research Center and
Ruanne Barnabas, University of Washington

Design of an alternative-dose schedule trial evaluating the Innovax bivalent HPV vaccine
Niranjan Bhat, PATH

Q&A

Overview of new HPV prophylactic vaccines in development
Peter Dull, The Bill & Melinda Gates Foundation

Immunobridging trials for new schedules and vaccines: A regulatory perspective
Jeff Roberts, U.S. Food and Drug Administration

Q&A and Open discussion