NCT04362995

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,316

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

April 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2024

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2024

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

4.2 years

First QC Date

April 22, 2020

Last Update Submit

August 9, 2024

Conditions

COVID-19Coronavirus InfectionCoronavirusSARS-CoV-2

Outcome Measures

Primary Outcomes (3)

  • Proportion of asymptomatic subjects

    The proportion of participants who test positive for SARS-CoV-2 infection but remain asymptomatic.

    1 year from enrollment

  • Positive CD4 and CD8 cell epitope positive response

    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.

    at enrollment, 3 months, 6 months, 9 months and 1 year

  • Positive CD4 and CD8 cell epitope positive response

    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.

    up to 48 months of additional observation in participants who have had COVID-19 or vaccination

Secondary Outcomes (5)

  • Proportion of seroprevalence

    Baseline, 3 months, 6 months, 9 months and 1 year

  • T-cell response

    Baseline, 3 months, 6 months, 9months, 1 year and 6 monthly for an additional 48 months in participants included in the long-term follow-up arm

  • Protective antibody responses against SARS-CoV-2 at last follow-up sample

    up to 48 months of additional observation in participants who have had COVID-19 or vaccination

  • Change in antibody responses to SARS-CoV-2

    up to 48 months of additional observation in participants who have had COVID-19 or vaccination

  • Saliva antibody and cytokine responses to SARS-CoV-2

    up to 48 months of additional observation in participants who have had COVID-19 or vaccination

Study Arms (3)

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

Long Term Follow Up (LTFU)

Subset of participants who participated in the original SJTRC study and agree to continue in LTFU

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

St. Jude employees who meet the eligibility criteria.

You may qualify if:

  • 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.
  • Willing to undergo blood draws on up to 5 occasions during the study.
  • 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.
  • Have access to a personal smartphone that is able to receive and respond to text messages for data collection.
  • Has ready access to the internet to log personal study information into the REDCap database.
  • Self-identified as able to speak and read English well enough to understand the consent process and survey forms, and to report symptoms.
  • Adult St. Jude employees (age ≥ 18 years of age) who participated in the original SJTRC study.
  • Willing to undergo blood draws on up to five occasions during the LTFU arm. Willing to provide saliva samples at acute and convalescent episodes.
  • Have access to a personal smartphone that is able to receive and respond to text messages for data collection.
  • Have ready access to the internet to log personal study information into the REDCap database.
  • Self-identified as able to speak and read English well enough to understand the consent process and questionnaires, and to report symptoms.

You may not qualify if:

  • 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.
  • Employees who cannot complete the informed consent process.
  • Employees who did not participate in the original SJTRC study.
  • Employees who cannot complete the informed consent process.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (1)

  • Schultz-Cherry S, McGargill MA, Thomas PG, Estepp JH, Gaur AH, Allen EK, Allison KJ, Tang L, Webby RJ, Cherry SD, Lin CY, Fabrizio T, Tuomanen EI, Wolf J; SJTRC Investigative Team. Cross-reactive Antibody Response to mRNA SARS-CoV-2 Vaccine After Recent COVID-19-Specific Monoclonal Antibody Therapy. Open Forum Infect Dis. 2021 Aug 10;8(9):ofab420. doi: 10.1093/ofid/ofab420. eCollection 2021 Sep.

    PMID: 34557558DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

blood, saliva, and nasal samples

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Paul G. Thomas, PhD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2020

First Posted

April 27, 2020

Study Start

April 23, 2020

Primary Completion

July 10, 2024

Study Completion

July 29, 2024

Last Updated

August 12, 2024

Record last verified: 2024-08

Locations

US(1)