Characterizing SARS-CoV-2-specific Immunity in Individuals Who Have Recovered From COVID-19
- Conditions
- SARS-CoV-2COVID-19
- Interventions
- Other: Sample collection
- Registration Number
- NCT04403880
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 759
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Sample collection 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 Group 2 Sample collection 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 Group 3 Sample collection 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)
- Primary Outcome Measures
Name Time Method Humoral responses to peptide antigens derived from SARS-CoV-2 structural proteins and regions of the spike protein not present in vaccines Measured through participant's last visit at Month 0, 2, 4, or 12 Measured by peptide microarray
SARS-CoV-2-specific CD4+ and CD8+ T cell response rate Measured through participant's last visit at Month 0, 2, 4, or 12 Measured by flow cytometry
SARS-CoV-2-specific infection presentation, including clinical course, along with demographics and corresponding medical history of participants Measured through participant's last visit at Month 0, 2, 4, or 12 Tabulated overall and by group
SARS-CoV-2-specific CD4+ and CD8+ T cell response magnitude Measured through participant's last visit at Month 0, 2, 4, or 12 Measured by flow cytometry
SARS-CoV-2-specific antibody binding response magnitude Measured through participant's last visit at Month 0, 2, 4, or 12 Measured by binding antibody multiplex assay (BAMA)
SARS-CoV-2-specific Antibody-Dependent Cellular Cytotoxicity (ADCC) response rate Measured through participant's last visit at Month 0, 2, 4, or 12 Measured by antibody-dependent cellular cytotoxicity assay (ADCC)
SARS-CoV-2-specific Antibody-Dependent Cellular Cytotoxicity (ADCC) response epitope specificity Measured through participant's last visit at Month 0, 2, 4, or 12 Measured by antibody-dependent cellular cytotoxicity assay (ADCC)
SARS-CoV-2-specific CD4+ and CD8+ T cell responses Measured through participant's last visit at Month 0, 2, 4, or 12 Measured by flow cytometry
SARS-CoV-2-specific antibody binding response rate Measured through participant's last visit at Month 0, 2, 4, or 12 Measured by binding antibody multiplex assay (BAMA)
SARS-CoV-2-specific antibody binding response epitope specificity Measured through participant's last visit at Month 0, 2, 4, or 12 Measured by binding antibody multiplex assay (BAMA)
SARS-CoV-2-specific antibody neutralization response rate Measured through participant's last visit at Month 0, 2, 4, or 12 Measured by neutralizing antibody assay (NAb)
SARS-CoV-2-specific antibody neutralization response magnitude Measured through participant's last visit at Month 0, 2, 4, or 12 Measured by neutralizing antibody assay (NAb)
SARS-CoV-2-specific antibody neutralization response epitope specificity Measured through participant's last visit at Month 0, 2, 4, or 12 Measured by neutralizing antibody assay (NAb)
SARS-CoV-2-specific Antibody-Dependent Cellular Cytotoxicity (ADCC) response magnitude Measured through participant's last visit at Month 0, 2, 4, or 12 Measured by antibody-dependent cellular cytotoxicity assay (ADCC)
SARS-CoV-2-specific CD4+ and CD8+ T cell response functional profiling Measured through participant's last visit at Month 0, 2, 4, or 12 Measured by flow cytometry
SARS-CoV-2-specific memory B cell characterization Measured through participant's last visit at Month 0, 2, 4, or 12 Measured by phenotyping and monoclonal antibody isolation
- Secondary Outcome Measures
Name Time Method Response rate of SARS-CoV-2-specific binding antibodies in nasal samples Measured through participant's last visit at Month 0, 2, 4, or 12 Measured by binding antibody multiplex assay (BAMA)
Detection of viral RNA in nasopharyngeal or nasal swab samples 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
Response magnitude of SARS-CoV-2-specific binding antibodies in nasal samples Measured through participant's last visit at Month 0, 2, 4, or 12 Measured by binding antibody multiplex assay (BAMA)
Trial Locations
- Locations (53)
Zengeza CRS
🇿🇼Chitungwiza, Zimbabwe
University of Rochester Vaccines to Prevent HIV Infection CRS
🇺🇸Rochester, New York, United States
Columbia P&S CRS
🇺🇸New York, New York, United States
Groote Schuur HIV CRS
🇿🇦Cape Town, South Africa
Isipingo CRS
🇿🇦Isipingo, South Africa
Bronx Prevention Research Center CRS
🇺🇸Bronx, New York, United States
Emavundleni CRS
🇿🇦Cape Town, South Africa
Khayelitsha CRS / (CIDRI UCT)
🇿🇦Cape Town, South Africa
New York Blood Center CRS
🇺🇸New York, New York, United States
Botha's Hill CRS
🇿🇦Durban, South Africa
Tembisa Clinic 4 CRS
🇿🇦Tembisa, South Africa
Qhakaza Mbokodo Research Clinic CRS
🇿🇦Ladysmith, South Africa
Harlem Prevention Center CRS
🇺🇸New York, New York, United States
Malawi CRS
🇲🇼Lilongwe, Malawi
Josha Research CRS
🇿🇦Bloemfontein, South Africa
Masiphumelele Clinical Research Site (MASI) CRS
🇿🇦Cape Town, South Africa
CAPRISA eThekwini CRS
🇿🇦Durban, South Africa
Via Libra CRS
🇵🇪Lima, Peru
Soweto HVTN CRS
🇿🇦Johannesburg, South Africa
Synexus Stanza Clinical Research Centre CRS
🇿🇦Pretoria, South Africa
Setshaba Research Centre CRS
🇿🇦Soshanguve, South Africa
Kliptown Soweto CRS
🇿🇦Johannesburg, South Africa
Nelson Mandela Academic Research Unit CRS
🇿🇦Mthatha, South Africa
The Aurum Institute Tembisa Clinical Research Centre CRS
🇿🇦Tembisa, South Africa
Bridge HIV CRS
🇺🇸San Francisco, California, United States
Chapel Hill CRS
🇺🇸Chapel Hill, North Carolina, United States
CITBM - UNIDEC, Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS
🇵🇪Bellavista, Callao, Peru
Barranco CRS
🇵🇪Lima, Peru
Chatsworth CRS
🇿🇦Chatsworth, South Africa
Rustenburg CRS
🇿🇦Rustenburg, South Africa
Tongaat CRS
🇿🇦Tongaat, South Africa
UCLA CARE Center CRS
🇺🇸Los Angeles, California, United States
The Ponce de Leon Center CRS
🇺🇸Atlanta, Georgia, United States
Penn Prevention CRS
🇺🇸Philadelphia, Pennsylvania, United States
The Hope Clinic of the Emory Vaccine Center CRS
🇺🇸Decatur, Georgia, United States
Adolescent & Young Adult Research at The CORE Center (AYAR at CORE)
🇺🇸Chicago, Illinois, United States
Fenway Health Clinical Research Site CRS
🇺🇸Boston, Massachusetts, United States
New Jersey Medical School Clinical Research Center CRS
🇺🇸Newark, New Jersey, United States
Seattle Vaccine and Prevention CRS
🇺🇸Seattle, Washington, United States
Johns Hopkins University CRS
🇺🇸Baltimore, Maryland, United States
Vanderbilt Vaccine CRS
🇺🇸Nashville, Tennessee, United States
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
🇺🇸Boston, Massachusetts, United States
New Orleans Adolescent Trials Unit CRS
🇺🇸New Orleans, Louisiana, United States
George Washington University CRS
🇺🇸Washington, District of Columbia, United States
Asociacion Civil Selva Amazonica (ACSA) CRS
🇵🇪Iquitos, Maynas, Peru
San Miguel CRS
🇵🇪San Miguel, Lima, Peru
Matero Reference Clinic CRS
🇿🇲Lusaka, Zambia
St Mary's CRS
🇿🇼Chitungwiza, Zimbabwe
Seke South CRS
🇿🇼Harare, Zimbabwe
Alabama Vaccine CRS
🇺🇸Birmingham, Alabama, United States
Verulam CRS
🇿🇦Verulam, South Africa
Vulindlela CRS
🇿🇦Durban, South Africa
Aurum Institute Klerksdorp CRS
🇿🇦Klerksdorp, South Africa