St. Jude Tracking of Viral and Host Factors Associated With COVID-19

Summary

This is a prospective adaptive cohort study of St. Jude employees to determine the rate of SARS-CoV-2 infections that are asymptomatic and to evaluate immunological responses to SARS-CoV-2 infection.

Primary Objectives

* To estimate the proportion of asymptomatic infection with SARS-CoV-2 infection in a population of SARS-CoV-2-naïve adult St. Jude employees
* To comprehensively map CD4 and CD8 T cell epitopes and response magnitudes to SARS-CoV-2 infection in a population of SARS-CoV-2-naïve adult St. Jude employees who acquire SARS-CoV-2 infection
* To measure changes in the CD4 and CD8 response magnitude and function to SARS-CoV-2 infection and/or vaccination in a population of St. Jude employees for up to 48 months after infection and/or vaccination.

Secondary Objectives

* To establish seroprevalence of SARS-CoV-2-specific antibodies at baseline, and identify the rate of seroconversion to SARS-CoV-2 in a population of presumably naïve adult St. Jude employees
* To identify features of T cell responses at baseline and during SARS-CoV-2 infection that are associated with protection against symptomatic or severe COVID-19 disease in a population of adult St. Jude employees
* To identify risk factors for long-term protection against COVID-19 in a population of adult St. Jude employees
* To evaluate changes in antibody responses to SARS-CoV-2 in a population of St. Jude employees for up to 48 months after SARS-CoV-2 infection and/or vaccination.
* To evaluate the saliva antibody and cytokine response to SARS-CoV-2 infection and/or vaccination and identify characteristics that predict protection from subsequent SARS-CoV-2 infection among a population of St. Jude employees followed for up to 48 months after SARS-CoV-2 infection and/or vaccination.
* To measure changes in saliva antibody responses to SARS-CoV-2 for up to 48 months after SARS-CoV-2 infection and/or vaccination.

Exploratory Objectives

* To establish additional immunological features including host immune or receptor polymorphisms associated with response to SARS-CoV-2 infection
* To explore SARS-CoV-2 diversity and specific features in a circumscribed population
* To describe the presence, characteristics, and proportion of short-term re-infection
* To determine if an association between SARS-CoV-2 viral load in nasal swab specimens and COVID-19 symptoms can be identified in a population of adult St. Jude employees who acquire SARS-CoV-2
* To explore the laboratory and clinical response to SARS-CoV-2 vaccine in a population of adult St. Jude employees with and without a history of SARS-CoV-2 infection

Conditions

• COVID-19
• Coronavirus Infection
• Coronavirus
• SARS-CoV-2

Sponsors & Collaborators

• University of Georgia

  collaborator OTHER

• University of Wisconsin, Madison

  collaborator OTHER

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• St. Jude Children's Research Hospital

  lead OTHER

Principal Investigators

• Paul G. Thomas, PhD · St. Jude Children's Research Hospital

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-04-23

Primary Completion

2024-07-10

Completion

2024-07-29

Countries

• United States

Study Locations