Members of the HPV Serology Laboratory. From left to right: Troy Kemp; Beth Schafer; Ligia Pinto; Casper Alabanza; and Christine Newkirk.

A new international initiative, led by scientists at the Frederick National Laboratory for Cancer Research and several other institutions, is being launched to provide expertise and leadership on the development, validation, and standardization of human papillomavirus (HPV) serology assays to be used in vaccine trials. HPV serology assays measure antibody responses following exposure to HPV or HPV vaccines.

High-risk HPVs cause several types of cancer and are responsible for approximately five percent of all cancers worldwide. Virtually all cases of cervical cancer are caused by HPV, which is a leading cause of cancer in women in the developing world.

There are three licensed HPV vaccines with excellent efficacy against cervical cancer and HPV infection at other anatomic sites where HPV induces cancer, such as the anus and oral cavity. However, implementing the vaccines, particularly in the developing world, has been problematic due to their high cost and the challenges associated with delivery. The development of low cost, second-generation HPV vaccines in developing countries and modification of existing vaccines, such as combinations with commonly administered vaccines, is limited. This is due to the lack of easily accessible, uniform, and standardized techniques, as well as the lack of processes and reagents for monitoring immune responses induced by licensed vaccines.

The HPV Serology Laboratory at the Frederick National Lab launched an initiative in January 2017 co-funded by the Bill and Melinda Gates Foundation to address this challenge by standardizing and harmonizing serological assays for HPV antibody testing. The national lab is sponsored by the National Cancer Institute (NCI).

“Standardized assays, reagents, and procedures are critical to ensure data quality and allow comparison of results from different studies and vaccines,” said Ligia Pinto, Ph.D., principal investigator, HPV Serology Laboratory, Frederick National Lab. “This will facilitate decision-making on new HPV vaccine use recommendations and/or candidates, and, thus, may accelerate vaccine implementation.”

Pinto’s HPV Immunology Laboratory has evaluated immune responses to HPV vaccines for more than a decade, and it played a significant role in understanding the immunogenicity—the ability of an antigen to provoke an immune response—of the currently licensed HPV vaccines.

The HPV Serology Laboratory will be working closely with the HPV serology scientific community to build on existing resources to develop secondary assay standards, critical reagents, and high-throughput assays to efficiently test for HPV vaccine immune responses in new HPV vaccine trials. With its location at the Frederick National Lab, the lab is near experts in protein and assay characterization, who can share their knowledge and expertise to help achieve the lab’s mission.

“One impact of this project is to accelerate the implementation of new, less costly vaccines and new vaccine indications by enabling comparison of immune responses to new, lower-cost vaccines with licensed vaccines (immunobridging) and to simplify vaccine indications, such as alternate and reduced dose regimens, that will be less costly and easier to implement in resource-limited places,” said Pinto. “With this initiative, we feel we have a unique opportunity to link the laboratory work directly with a public impact mission, from the bench to the ‘field.’”

By Max Cole, staff writer; photo by Richard Frederickson, staff photographer.

Image: Members of the HPV Serology Laboratory. From left to right: Troy Kemp; Beth Schafer; Ligia Pinto; Casper Alabanza; and Christine Newkirk.