Last Updated

21 Jul 2020

Characterizing SARS-CoV-2-specific Immunity in Individuals Who Have Recovered From COVID-19

Objectives

This study aims to characterize the SARS-CoV-2-specific immunity in convalescent individuals.

  • To identify serologic reactivities that differentiate SARS-CoV-2 infection from vaccination.
  • To develop and formally qualify a suite of immunologic assays and reference reagents that permit detailed interrogations of the immune response to SARS-CoV-2 infection in preparation for similar assessments of vaccine-elicited immune responses and immunotherapeutics.
  • To measure SARS-CoV-2-specific adaptive immune responses in order to identify immune markers of COVID-19 disease severity and duration in different demographic groups (eg, age, gender) and in people with different medical histories, including pre-existing conditions, new acute or chronic medical conditions, and concomitant medications.
  • To characterize presentations of SARS-CoV-2 infection, including the clinical course of COVID-19, among convalescent individuals.
Principal Investigator
Funding Information
Awarded for HIV Vaccine Trials Network
Rationale and Abstract

The purpose of this study is to learn more about infection with and recovery from the virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Some people know this virus by the name "coronavirus." It can cause the disease called COVID-19.

The information gained from the study will be used to help develop better tests for SARS-CoV-2 infection and COVID-19 disease and may help in developing future vaccines and treatments by allowing researchers to determine the difference between the body's immune response to natural SARS-CoV-2 infection and immunization with a SARS-CoV-2 vaccine.

Study Design

The observational cohort study will include 3 groups, as described below.

Participants will complete a minimum of one visit (1-8 weeks post resolution of COVID-19 OR 2-10 weeks post most recent positive SARS-CoV-2 test, if asymptomatic) and optional visits approximately 2 months, 4 months, and 1 year later. Additional follow up visit(s) may be added over time in response to evolving information regarding SARS-CoV-2 infection and COVID-19.

Study visits may include physical examinations, medical history, questionnaires, pregnancy tests (for participants assigned female at birth), blood draws, and optional nasal samples.

Group 1
Persons not hospitalized for COVID-19, without clinical spectrum or outcomes specified in group 3

  • 1A: Persons with asymptomatic infection, ages 18 through 55, inclusive
  • 1B: Persons with asymptomatic infection, age > 55
  • 1C: Persons with symptomatic infection (ie, COVID-19) ages 18 through 55
  • 1D: Persons with symptomatic infection (ie, COVID-19), age > 55
  • Other: Sample collection
  • Optional nasal specimen(s)
  • Blood collection

Group 2
Persons previously hospitalized for COVID-19, without clinical spectrum or outcomes specified in group 3

  • 2A: Persons 18 through 55 years of age
  • 2B: Persons > 55 years of age
  • Other: Sample collection
  • Optional nasal specimen(s)
  • Blood collection

Group 3
Persons with specific clinical spectrums or outcomes, regardless of hospitalization history (eg, persons recovered after intubation, with prolonged viral shedding, with myocarditis/pericarditis, with rapid recovery from COVID-19, with a second positive SARS-CoV-2 RT-PCR test result after a negative result)

  • Other: Sample collection
  • Optional nasal specimen(s)
  • Blood collection

 

Primary Outcome Measures  :

  1. Humoral responses to peptide antigens derived from SARS-CoV-2 structural proteins and regions of the spike protein not present in vaccines [ Time Frame: Measured through participant's last visit at Month 0, 2, 4, or 12 ]

    Measured by peptide microarray

  2. SARS-CoV-2-specific antibody binding response rate [ Time Frame: Measured through participant's last visit at Month 0, 2, 4, or 12 ]

    Measured by binding antibody multiplex assay (BAMA)

  3. SARS-CoV-2-specific antibody binding response magnitude [ Time Frame: Measured through participant's last visit at Month 0, 2, 4, or 12 ]

    Measured by binding antibody multiplex assay (BAMA)

  4. SARS-CoV-2-specific antibody binding response epitope specificity [ Time Frame: Measured through participant's last visit at Month 0, 2, 4, or 12 ]

    Measured by binding antibody multiplex assay (BAMA)

  5. SARS-CoV-2-specific antibody neutralization response rate [ Time Frame: Measured through participant's last visit at Month 0, 2, 4, or 12 ]

    Measured by neutralizing antibody assay (NAb)

  6. SARS-CoV-2-specific antibody neutralization response magnitude [ Time Frame: Measured through participant's last visit at Month 0, 2, 4, or 12 ]

    Measured by neutralizing antibody assay (NAb)

  7. SARS-CoV-2-specific antibody neutralization response epitope specificity [ Time Frame: Measured through participant's last visit at Month 0, 2, 4, or 12 ]

    Measured by neutralizing antibody assay (NAb)

  8. SARS-CoV-2-specific Antibody-Dependent Cellular Cytotoxicity (ADCC) response rate [ Time Frame: Measured through participant's last visit at Month 0, 2, 4, or 12 ]

    Measured by antibody-dependent cellular cytotoxicity assay (ADCC)

  9. SARS-CoV-2-specific Antibody-Dependent Cellular Cytotoxicity (ADCC) response magnitude [ Time Frame: Measured through participant's last visit at Month 0, 2, 4, or 12 ]

    Measured by antibody-dependent cellular cytotoxicity assay (ADCC)

  10. SARS-CoV-2-specific Antibody-Dependent Cellular Cytotoxicity (ADCC) response epitope specificity [ Time Frame: Measured through participant's last visit at Month 0, 2, 4, or 12 ]

    Measured by antibody-dependent cellular cytotoxicity assay (ADCC)

  11. SARS-CoV-2-specific CD4+ and CD8+ T cell responses [ Time Frame: Measured through participant's last visit at Month 0, 2, 4, or 12 ]

    Measured by flow cytometry

  12. SARS-CoV-2-specific CD4+ and CD8+ T cell response rate [ Time Frame: Measured through participant's last visit at Month 0, 2, 4, or 12 ]

    Measured by flow cytometry

  13. SARS-CoV-2-specific CD4+ and CD8+ T cell response magnitude [ Time Frame: Measured through participant's last visit at Month 0, 2, 4, or 12 ]

    Measured by flow cytometry

  14. SARS-CoV-2-specific CD4+ and CD8+ T cell response functional profiling [ Time Frame: Measured through participant's last visit at Month 0, 2, 4, or 12 ]

    Measured by flow cytometry

  15. SARS-CoV-2-specific memory B cell characterization [ Time Frame: Measured through participant's last visit at Month 0, 2, 4, or 12 ]

    Measured by phenotyping and monoclonal antibody isolation

  16. SARS-CoV-2-specific infection presentation, including clinical course, along with demographics and corresponding medical history of participants [ Time Frame: Measured through participant's last visit at Month 0, 2, 4, or 12 ]

    Tabulated overall and by group

 

Secondary Outcome Measures  :

  1. Detection of viral RNA in nasopharyngeal or nasal swab samples [ Time Frame: Measured through participant's last visit at Month 0, 2, 4, or 12 ]

    Measured by real-time reverse transcription polymerase chain reaction (RT-PCR) assay

  2. Response rate of SARS-CoV-2-specific binding antibodies in nasal samples [ Time Frame: Measured through participant's last visit at Month 0, 2, 4, or 12 ]

    Measured by binding antibody multiplex assay (BAMA)

  3. Response magnitude of SARS-CoV-2-specific binding antibodies in nasal samples [ Time Frame: Measured through participant's last visit at Month 0, 2, 4, or 12 ]

    Measured by binding antibody multiplex assay (BAMA)

 

Date

2020 May - 2021 Aug

Funding Details

Awarded for HIV Vaccine Trials Network
Project Site
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