The HPV and COVID-19 Serology Laboratories are world leaders in the development, validation, and standardization of serology assays for HPV and COVID-19. 

These laboratories develop standards and reference reagents that enable scientists to compare data derived from different studies and vaccines.

Serology standards enable data comparison between studies

The FNL team leads standardization and development of HPV and COVID-19 serology assays to support vaccine immunogenicity and natural infection studies. The team also developed international and U.S. Serology Standards.

Leveraging unique serological sciences expertise 

The HPV and COVID-19 Serology Laboratories lead studies of immune responses to HPV and SARS-CoV-2 infections and vaccines and have developed globally recognized serology standards.  

The HPV Laboratory was one of the first groups to demonstrate immunogenicity of a single dose of the HPV vaccine in parallel with efficacy, raising the possibility of one-dose schedules. With funding from the National Cancer Institute and the Bill and Melinda Gates Foundation, the laboratory has focused on identifying and addressing gaps in HPV serology standardization and conducted serology testing in the context of large-scale epidemiological studies and vaccine trials.  

At the start of the COVID-19 pandemic in 2020, our scientists quickly pivoted to develop serology assays and standards and to evaluate the performance of SARS-CoV-2 antibody tests for the U.S. Food and Drug Administration. In addition to HPV, the laboratory expanded to COVID-19 serology and immunology research and developed the Human SARS-CoV-2 Serology Standard and SARS-CoV-2 serology evaluation panels, which are available to the scientific community to promote global serology assay standardization.  

Collaboration Opportunities

VICD laboratories collaborate with partners across the globe. We have established strong technological capabilities and resources that support pre-clinical and clinical studies in immunology with in-house validated assays that generated a wealth of data in high-impact studies.

We work closely with National Institutes of Health and centers worldwide that are interested in conducting studies from preclinical to clinical trials, in vaccine development, assay development and validations, and critical reagents acquisition. VICD engages with external centers through partnership mechanisms, which are primarily Material Transfer Agreements (MTAs) and Cooperative Research and Development Agreement (CRADA).

To connect or collaborate with VICD, contact Bo Park, Director, Administrative and Finance.

Understanding immunity to HPV and COVID-19 vaccines 

The HPV Laboratory is testing antibody levels and avidity in various one-dose HPV vaccine trials. The COVID-19 Laboratory is testing antibody responses to SARS-CoV-2 infection and vaccination in healthy individuals and cancer patients.

The HPV and COVID-19 Serology Laboratories collaborate with the National Cancer Institute, inter-government agencies, including the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention, the National Institute of Standards and Technology, and the Biomedical Advanced Research and Development Authority, as well as academic and international laboratories and organizations such as the National Institute for Biological Standards and Control and the World Health Organization, to develop standards and assays, and conduct vaccine immunogenicity studies in healthy individuals and in people with cancer and other immunocompromising conditions.

Our capabilities and specializations

Serology characterization 

We have extensive experience in developing, qualifying, and validating serology-based assays as well as conducting testing using Good Clinical Laboratory Practice (GCLP) guidelines. 

  • Antibody level and avidity determination via binding assays
  • Binding singleplex and multiplex assays 
  • Functional serology assays, including HPV PsV-based neutralization

HPV VLP production 

The HPV Laboratory produces HPV virus-like particles (VLPs) using mammalian production methods. These HPV VLPs are available to the scientific community as reference materials. 

  • Mammalian cell production methods
  • Monoclonal antibody specificity testing

ELISA training

Our group conducts enzyme-linked immunosorbent assay (ELISA) training and provides training materials to laboratories worldwide.

  • Onsite ELISA training
  • Onsite VLP production training
  • Standard operating procedures for ELISA testing and VLP production