***UPDATE: The HPV Serology Laboratory is currently contributing to the broader Health and Human Services response by evaluating serology tests for the novel coronavirus, SARS-CoV-2, and reporting performance data on serology tests to the U.S. Food and Drug Administration.***
Protection against Human Papillomavirus (HPV) infection after vaccination is believed to be mediated by HPV-specific antibodies. Antibody responses in HPV prophylactic vaccine trials have been assessed using different methods.
The lack of standardized assays, procedures, and reagents accessible to the scientific community has precluded the comparison of different studies evaluating immunogenicity of HPV vaccines.
With an expected increase in the number of trials relying on immunobridging for approval of new dosing schedules or vaccine formulations, there is a critical need for standardized measurement and reporting of immunogenicity to reliably assess non-inferiority of antibody responses and improve overall comparability between studies.
The HPV Serology Laboratory at the Frederick National Laboratory was established in January 2017 to address some of these needs and advance HPV assay standardization.