HPV Serology

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Human Papillomavirus infection is mostly benign and self-limiting, however certain genotypes are considered high risk and oncogenic. HPV has been found in virtually all cervical cancers with HPV 16 causing 50% and HPV 18 another 20%. Currently, there are three licensed human papillomavirus (HPV) vaccines with excellent efficacy, but poorly characterized correlates of vaccine induced immunity. One of the vaccines is bivalent (Cervarix, GSK), the second is quadrivalent (Gardasil, Merck), while the third is nonavalent (Gardasil9). All three vaccines utilize virus like particles (VLPs) based on the L1 major capsid protein from HPV. VLPs are noninfectious protein capsids which can be produced by expressing the capsid protein in yeast or insect cells. The recombinant L1 capsid protein assembles in into the 60-nm HPV VLP. The efficacy of each vaccine has been evaluated with different standards, making comparison of the vaccines difficult. There has also been indication suggesting that one dose of these vaccines may be as efficacious as the three-dose regimen currently in use, however there is no set of serological standards that could be used for evaluation. Currently, pooled human serum serves as the best standard and is used to create a curve from which results are extrapolated in arbitrary Units/ml. However, the pooled serum is a finite resource and subsequent studies require the development of a new pool that is calibrated against the previous pool and therefore has its limitations as a standard. The goal is to establish a laboratory that would standardize and harmonize serological assays for Human Papillomavirus (HPV) antibody testing through development of validated reagents and standards that will be available to the scientific community. The laboratory will provide well qualified and standardized high-throughput testing that adheres to regulatory requirements defined for vaccine development and implementation. The laboratory will work with the scientific community and regulatory entities to identify unmet needs in HPV serology.