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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04403880
Recruitment Status : Active, not recruiting
First Posted : May 27, 2020
Last Update Posted : April 14, 2021
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
HIV Prevention Trials Network
Information provided by (Responsible Party):
HIV Vaccine Trials Network

Brief Summary:

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.


Condition or disease Intervention/treatment
SARS-CoV-2 COVID-19 Other: Sample collection

Detailed Description:

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

The observational cohort study will include 3 groups, as described in the table 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. Participants diagnosed with SARS-CoV-2 infection at an optional follow-up visit may be contacted more frequently. 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, optional nasal samples, and optional HIV testing.

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Study Type : Observational
Estimated Enrollment : 727 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Characterizing SARS-CoV-2-specific Immunity in Convalescent Individuals
Actual Study Start Date : May 13, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Persons reporting a positive test for SARS-CoV-2 and resolution of COVID-19 within 1-8 weeks of enrollment OR, if asymptomatic infection, reporting positive SARS-CoV-2 test within 2-10 weeks of enrollment.
Criteria

Inclusion Criteria:

  • Age 18 or older.
  • Reports having had a positive test for SARS-CoV-2.
  • Reports resolution of COVID-19 within 1-8 weeks of enrollment OR, if asymptomatic infection, reports positive SARS-CoV-2 test within 2-10 weeks of enrollment. Not excluded: individuals with symptoms consistent with residual sequelae of resolved COVID-19, in the clinical judgement of the investigator.
  • Access to a participating HVTN or HPTN CRS and willingness to be followed for the planned duration of the study.
  • Ability and willingness to provide informed consent.
  • Assessment of understanding: volunteer demonstrates understanding of this study.
  • Volunteers who were assigned female sex at birth: negative urine or serum beta human chorionic gonadotropin (β-HCG) pregnancy test within 4 days of enrollment visit (ie, prior to enrollment blood draw or nasal collections). Persons who are NOT of reproductive potential due to having undergone hysterectomy or bilateral oophorectomy (verified by medical records) or having reached menopause (no menses for ≥ 1 year ), are not required to undergo pregnancy testing.

Exclusion Criteria:

  • Reports current COVID-19.
  • Pregnant.
  • Receipt of SARS-CoV-2 specific antibodies (eg, convalescent plasma or sera, monoclonal antibodies, hyperimmune globulin). Not excluded: antibody therapy without SARS-CoV-2 specificity (eg, IL-6 pathway inhibitors for COVID-19).
  • SARS-CoV-2 vaccine(s) received in a prior vaccine trial.
  • Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence or a volunteer's ability to give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04403880


Locations
Show Show 53 study locations
Sponsors and Collaborators
HIV Vaccine Trials Network
National Institute of Allergy and Infectious Diseases (NIAID)
HIV Prevention Trials Network
Investigators
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Study Chair: Larry Corey HIV Vaccine Trials Network, Fred Hutch
Study Chair: Shelly Karuna HIV Vaccine Trials Network, Fred Hutch
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Responsible Party: HIV Vaccine Trials Network
ClinicalTrials.gov Identifier: NCT04403880    
Other Study ID Numbers: HVTN 405/HPTN 1901
5UM1AI068614-14 ( U.S. NIH Grant/Contract )
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No