Characterizing SARS-CoV-2-specific immunity in individuals who have recovered from COVID-19

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 a 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.

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)

NIH Reporter - Project 5UM1AI068614-14Clinical Trials NCT04403880

Vaccines (Immune Correlates)

May 2020 — Aug 2021

Peru
United States

Clinical Epidemiology of COVID-19 in Malaria Settings