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NCI Initiatives on the Human Immune Response to SARS-CoV-2

, by Dr. Douglas R. Lowy and Dr. Dinah S. Singer

In this post, Dr. Douglas R. Lowy and Dr. Dinah S. Singer, provide an update on NCI’s recently launched Serological Sciences Network (SeroNet). Specifically, Drs. Lowy and Singer expand on three integrated components of SeroNet.

Dr. Singer and Dr. Lowy

Dr. Douglas R. Lowy, NCI Principal Deputy Director and Dr. Dinah S. Singer, NCI Deputy Director for Scientific Strategy and Development

A June Bottom Line blog post described elements of NCI’s Serological Sciences Network, or SeroNet, an initiative to understand the human immune response to SARS-CoV-2, the virus that causes COVID-19. Funding for SeroNet comes from $306 million allocated to NCI from the emergency appropriation Congress enacted in April. While NCI is aggressively moving forward with SeroNet, just like so many of you, cancer research and cancer patients remain our foremost priority.

The June blog post included details of two NCI funding opportunities that are cornerstones of SeroNet: U54 centers, known as Serological Sciences Centers of Excellence, and U01 research projects in serological sciences. In the coming weeks, NCI will peer review and score the applications we received and promptly make funding decisions on these important awards.

In addition to Centers of Excellence and serological sciences projects, SeroNet has three other integrated components:

  • the SeroNet Serology Lab
  • Serological Sciences Capacity Building Centers
  • a coordinating center, fostering collaboration across SeroNet

In this post, we want to describe these three components in greater detail.

SeroNet Serology Laboratory – This past spring, as the pandemic grew in scope, NCI rapidly converted part of its Human Papillomavirus (HPV) Serology Lab at the Frederick National Laboratory for Cancer Research (FNLCR) to evaluate antibody test kits that measure immune response to the virus that causes COVID-19. We redirected lab priorities to support our sister agency, the Food and Drug Administration (FDA), and its efforts to validate test kits for the infection that triggered the pandemic.

Some background on the FNLCR Serology Lab offers insight into why NCI maintains this essential expertise. Before pivoting to COVID-19 serology, the HPV Serology Lab, with co-funding from the Bill and Melinda Gates Foundation, was developing global standards for assays used to measure antibody responses to the HPV vaccine and to natural HPV infection. HPV assay analysis is part of a broad collaboration on HPV with our U.S. and international public health partners. 

The HPV Serology Lab is an example of NCI’s longstanding commitment to understand and address viruses that cause cancer. A key priority for our serology lab is to permit HPV vaccine trials of the future to be immunogenicity trials rather than efficacy trials. Immunogenicity trials are smaller, can be completed sooner, and are less expensive to conduct. 

As COVID-19 emerged as a global pandemic, NCI’s HPV Serology Lab began sharing its unique scientific and technical expertise. The lab also pivoted its capacity to support the growing public health need for serology testing. Serology testing will determine whether a person has antibodies to SARS-CoV-2. If so, this means the individual is, or was, infected with the virus. The widespread availability of reliable serology tests is critical to understanding who has been infected with SARS-CoV-2 and supporting accurate population-wide seroprevalence studies. Further research may also provide insights into important questions about resistance to reinfection. 

The HPV Serology Lab now serves a vital role contributing to the COVID-19 response, by evaluating the sensitivity and specificity of test kits and supporting FDA decisions on which kits manufacturers can market. NCI has delivered analysis to FDA on many of the test kits developed by different manufacturers.  

Serological Sciences Capacity Building CentersWorking through our FNLCR, NCI also solicited proposals for Serological Sciences Capacity Building Centers (CBCs), another important SeroNet component designed to develop and expand the nation’s capacity for serological testing. Each CBC is expected to establish and then expand testing capacity, eventually achieving a screening capacity of 5,000 patients per week, per CBC. By funding four to eight CBCs, NCI expects to expand serological testing capacity, relying on highly specific and sensitive serological assays to test for an immune response to SARS-CoV-2.

In addition to significantly expanding testing capacity, the CBCs also offer an opportunity to conduct focused studies in serological sciences research and technology innovation. For example, NCI expects CBCs to collaborate in serosurveillance and sero-protection studies, including longitudinal studies to investigate the dynamics and variability of serological response to SARS-CoV-2 infection. 

In fact, collaboration on serosurveillance studies has begun; a study being conducted through the NIH All of Us program is already working with NCI’s SeroNet. Collaborating with All of Us and similar studies will provide important glimpses into the prevalence of antibodies to SARS-CoV2 just before or at the onset of the pandemic, which will enrich our understanding of the human immune response to SARS-CoV-2.

Serological Sciences Network Coordinating CenterNCI designed SeroNet to function as an integrated, interconnected network. Each component is expected to collaborate across the network, sharing expertise, data, resources, and samples. 

To further advance this goal, NCI is establishing a Serological Sciences Network Coordinating Center (SSNCC) as the final element of SeroNet. The Coordinating Center will foster synergy throughout SeroNet by managing and coordinating communications, as well as sharing data, protocols, and reagents across the network. SSNCC will be guided by a steering committee that provides scientific oversight, with representatives from each component of SeroNet.
    
As the June blog post emphasized, NCI planned all these elements of SeroNet in close coordination with our colleagues in the National Institute of Allergy and Infectious Diseases, as well as with our colleagues at FDA, the Centers for Disease Control and Prevention, and other components of the Department of Health and Human Services.

In the midst of a global pandemic, NCI is deploying our serology expertise to contribute to the COVID-19 response and help speed the availability of high quality, valid, and reliable serology tests. As we describe these important research opportunities, we also want to assure our extramural colleagues that NCI continues to maintain sharp focus on our cancer research mission. Like you, our enduring commitment is making scientific progress and delivering results for those suffering from cancer, those at risk of cancer, and the growing population of cancer survivors.

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