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

Completed

Conditions studied: SARS-CoV-2, COVID-19

In brief

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.

Key facts

Study ID

NCT04403880

Run by

HIV Vaccine Trials Network

People needed

760

Starts

2020-05-13

Expected to finish

2022-04-21

Last updated by the study team

2026-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UCLA CARE Center CRS — Los Angeles, California, United States
• Bridge HIV CRS — San Francisco, California, United States
• George Washington University CRS — Washington D.C., District of Columbia, United States
• The Ponce de Leon Center CRS — Atlanta, Georgia, 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
• New Orleans Adolescent Trials Unit CRS — New Orleans, Louisiana, United States
• Johns Hopkins University CRS — Baltimore, Maryland, United States
• Brigham and Women's Hospital Vaccine CRS (BWH VCRS) — Boston, Massachusetts, 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
• Harlem Prevention Center CRS — New York, New York, United States
• Columbia P&S CRS — New York, New York, United States
• New York Blood Center CRS — New York, New York, United States
• University of Rochester Vaccines to Prevent HIV Infection CRS — Rochester, New York, United States
• Bronx Prevention Research Center CRS — The Bronx, New York, United States
• Chapel Hill CRS — Chapel Hill, North Carolina, United States
• Penn Prevention CRS — Philadelphia, Pennsylvania, United States
• Vanderbilt Vaccine CRS — Nashville, Tennessee, United States
• Seattle Vaccine and Prevention CRS — Seattle, Washington, United States
• Malawi CRS — Lilongwe, Malawi
• San Miguel CRS — San Miguel, Lima region, Peru
• Asociacion Civil Selva Amazonica (ACSA) CRS — Iquitos, Maynas, Peru
• CITBM - UNIDEC, Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS — Bellavista, Provincia Constitucional del Callao, Peru
• Alabama Vaccine CRS — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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