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

Overview

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

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

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

Full Title of Study: “SJTRC-St. Jude Tracking of Viral and Host Factors Associated With COVID-19: A Prospective Adaptive Cohort Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 20, 2021

Detailed Description

Naive individuals will contribute a baseline blood sample at enrollment. Subsequent routine blood draws will occur to determine the proportion of participants who have asymptomatically seroconverted; the timing of these blood draws and proportion of participants required will be determined by the rate of documented SARS-CoV-2 infection in the cohort according to an adaptive study design. Subjects will be tracked for SARS-CoV-2 specific antibodies and CD4, and CD8 T cell responses throughout the period and especially during the early stages after clearance of infection and subsequently to determine the quality and duration of memory responses.

In addition to blood samples, participants will intermittently provide nasal swabs for detection of SARS-CoV-2; this will occur either through a comprehensive proactive employee screening program, or specifically for the purposes of the research study if participants are required to attend campus but are not currently eligible for employee screening. These will determine duration and characteristics of viral shedding and identify reinfection. Seroprevalence estimates and asymptomatic conversion will also be determined.

Individuals with a diagnosis of SARS-CoV-2 infection will have two additional blood draws in the acute and convalescent phase to identify acute and late immune responses. These responses will be compared to the essential baseline sample data to characterize the generation of de novo and cross-reactive recall responses.

At enrollment, subjects will complete a baseline online personal health and demographic questionnaire, and then monthly brief online health update questionnaires. Throughout the study period, subjects will complete a brief online symptom survey every 2 weeks.

Arms, Groups and Cohorts

  • SARS-CoV-2 Infection
    • St. Jude Children’s Research Hospital employees with SARS-CoV-2 infection
  • Controls
    • St. Jude Children’s Research Hospital employees uninfected with SARS-CoV-2 infection

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of asymptomatic subjects
    • Time Frame: 1 year from enrollment
    • The proportion of participants who test positive for SARS-CoV-2 infection but remain asymptomatic.
  • Positive CD4 and CD8 cell epitope positive response
    • Time Frame: at enrollment, 3 months, 6 months, 9 months and 1 year
    • A list of CD4 and CD8 cell epitopes with a magnitude change from baseline that is at least twice the standard deviation of the baseline.

Secondary Measures

  • Proportion of seroprevalence
    • Time Frame: Baseline, 3 months, 6 months, 9 months and 1 year
    • The proportion of participants at each time point who have detectable antibodies that recognize SARS-COV-2.
  • T-cell response
    • Time Frame: Baseline, 3 months, 6 months, 9months and 1 year
    • For CD8s, T cell responses will be categorized as cytolytic, cytokine producing, or exhausted. For CD4s they will be grouped as Th1, Th2, Tfh, or Th17. Percentages of cells in each category will be summarized at baseline and during SARS-CoV-2 infection.

Participating in This Clinical Trial

Inclusion Criteria

1. Adult St. Jude employees (Age ≥ 18 years of age) who are presumed to be SARS- CoV-2 naive, or have a recent diagnosis of COVID-19, and volunteer to participate.

2. Willing to undergo blood draws on up to 5 occasions during the study.

3. Receiving approximately twice-weekly SARS-CoV-2 screening by Occupational Health, or willing to provide up to twice weekly nasal self-swabs if attending campus.

4. Have access to a personal smartphone that is able to receive and respond to text messages for data collection.

5. Has ready access to the internet to log personal study information into the REDCap database.

6. Self-identified as able to speak and read English well enough to understand the consent process and survey forms, and to report symptoms.

Exclusion Criteria

1. Employees who are first-degree relatives of, or directly or indirectly report up to, the PI or any of the clinical study investigators who will have access to participant identities.

2. Employees who cannot complete the informed consent process.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • St. Jude Children’s Research Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Paul G. Thomas, PhD, Principal Investigator, St. Jude Children’s Research Hospital
  • Overall Contact(s)
    • Paul G. Thomas, PhD, 866-278-5833, referralinfo@stjude.org

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