This Funding Opportunity Announcement (FOA) is associated with the COVID-19 Supplement funded through the Paycheck Protection Program and Health Care Enhancement Act (P.L. 116-139) which directs the National Cancer Institute of the NIH “to develop, validate, improve, and implement serological testing and associated technologies “. The purpose of the FOA is to establish Serological Sciences Centers of Excellence with the goal of identifying and advancing research opportunities to characterize the immune responses elicited by SARS-CoV-2 viral infection; understanding the mechanisms driving the serological, humoral and cellular immune responses; determining host, genetic, and environmental modifiers of the immune response; determining the serological correlates of disease pathogenesis and protection against future infection; defining access, communication, and implementation barriers related to SARS-CoV-2 serological testing. These U54 Centers will be part of a Serological Sciences Network (SeroNet). Other components of the Network will include Serological Sciences Research Projects (U01), the FNLCR Serology Laboratory, Serological Capacity Building Centers (CBC) and a Serological Sciences Network Coordinating Center (SSNCC) which will be managed through Frederick National Lab for Cancer Research (FNLCR), a Federally Funded Research and Development Center. It may also include SBIR grants and other grants and contracts related to serology associated with SARS-CoV-2. All components are expected to collaborate across the entire Network, sharing data, results, and reagents.
There are multiple FOAs:
This one solicits multi-component U54 Center applications, whereas a companion FOA, RFA-CA-20-039, solicits applications for discrete U01 research projects. Successful applicants from both FOAs will become members of the Serological Sciences Network.
- Developing novel assays, and preclinical and computational model systems to test adaptive and innate immune responses to SARS-CoV-2 infection that inform immune parameters and serological markers associated with asymptomatic vs symptomatic infection, disease severity, risk of re-infection or vaccine efficacy.
- Understanding the mechanisms underlying innate, cell-mediated, and humoral immune responses to SARS-CoV-2 – including macrophage activating syndrome and cytokine storm – as well as how disease severity differs as a function of immune health status.
- Determine if therapeutics (e.g. remdesivir, antivirals) and passive antibody therapies used to treat COVID-19 modulate serologic and immune responses to SARS-CoV-2 (e.g. antibody-dependent enhancement).
- Characterizing the serologic differences resulting from natural infection vs. vaccination against SARS-CoV-2, and how they correlate with the persistence or longevity of the response.
- Identifying genetic and epigenetic determinants (e.g. HLA types) that modulate the development and durability of immune responses against SARS-CoV-2 infection and associated serological correlates.
- Understanding what factors affect the SARS-CoV-2 immune response or pathogenesis including SARS-CoV-2 viral load, health conditions (e.g., diabetes, obesity, cardiovascular disease, precancerous conditions), co-infection with other viruses (e.g., HIV, HPV, CMV), or the presence of endemic coronavirus antibodies.
- Understanding how precancerous conditions, cancer, and/or cancer therapies (i.e., chemotherapy, radiation, immunotherapy, hormonal therapy, combinations) affect serologic and immune responses to SARS-CoV-2 infection and the clinical course of infection, and conversely how the immune response to SARS-CoV-2 affects precancerous conditions, cancers, and responses to cancer therapies.
- Understanding how patient demographic factors (e.g., age, sex, ethnicity), behavioral (e.g., smoking, physical activity), and environmental factors affect immune or serological responses to SARS-CoV-2 infection.
- Researching the clinical and public health implementation of validated serologic assays, their interpretation, and follow-up for health outcomes.
- Approaches to promoting and ensuring equitable access to serologic testing, identification of contextual factors associated with the uptake of SARS-CoV-2 serologic testing, and whether differential access further exacerbates health disparities and health outcomes.
- Determining the ethical, legal and social implications of serologic testing for SARS-CoV-2 in diverse populations and the best methods for appropriate communication of results and interpretation at the individual, provider, and population level; for example, the impact of serologic testing on employment, housing, health insurance, access to federal benefits.
This is an emergency FOA due to the SARS-CoV-2 global pandemic; therefore, applicants do not need to provide extensive background information or preliminary data in this application.
Intervention trials addressing behavioral, health care delivery, or implementation research related to serologic testing and serologic outcomes are appropriate for this RFA. These research efforts should include a broad and diverse population, including consideration of age, sex, gender, race, socioeconomic status, rural populations, ethnicity, as well as specific vulnerable populations (e.g., individuals with comorbidities such as autoimmune disease, immunosuppression, and obesity, medically underserved, and cancer populations – across all age groups – childhood, adolescent and young adult, and older populations). Leveraging ongoing cohort studies and registry data is encouraged.
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Filed Under: Funding Opportunities