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.
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.
Other: Sample collection
Optional nasal specimen(s)
Blood collection
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.
Alabama Vaccine CRS
Birmingham, Alabama, United States
UCLA CARE Center CRS
Los Angeles, California, United States
Bridge HIV CRS
San Francisco, California, United States
George Washington University CRS
Washington, 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
Bronx Prevention Research Center CRS
Bronx, New York, 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
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
CITBM - UNIDEC, Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS
Bellavista, Callao, Peru
San Miguel CRS
San Miguel, Lima, Peru
Asociacion Civil Selva Amazonica (ACSA) CRS
Iquitos, Maynas, Peru
Via Libra CRS
Lima, Peru
Barranco CRS
Lima, Peru
Josha Research CRS
Bloemfontein, South Africa
Emavundleni CRS
Cape Town, South Africa
Groote Schuur HIV CRS
Cape Town, South Africa
Khayelitsha CRS / (CIDRI UCT)
Cape Town, South Africa
Masiphumelele Clinical Research Site (MASI) CRS
Cape Town, South Africa
Chatsworth CRS
Chatsworth, South Africa
Botha's Hill CRS
Durban, South Africa
CAPRISA eThekwini CRS
Durban, South Africa
Vulindlela CRS
Durban, South Africa
Isipingo CRS
Isipingo, South Africa
Kliptown Soweto CRS
Johannesburg, South Africa
Soweto HVTN CRS
Johannesburg, South Africa
Aurum Institute Klerksdorp CRS
Klerksdorp, South Africa
Qhakaza Mbokodo Research Clinic CRS
Ladysmith, South Africa
Nelson Mandela Academic Research Unit CRS
Mthatha, South Africa
Synexus Stanza Clinical Research Centre CRS
Pretoria, South Africa
Rustenburg CRS
Rustenburg, South Africa
Setshaba Research Centre CRS
Soshanguve, South Africa
Tembisa Clinic 4 CRS
Tembisa, South Africa
The Aurum Institute Tembisa Clinical Research Centre CRS
Tembisa, South Africa
Tongaat CRS
Tongaat, South Africa
Verulam CRS
Verulam, South Africa
Matero Reference Clinic CRS
Lusaka, Zambia
St Mary's CRS
Chitungwiza, Zimbabwe
Zengeza CRS
Chitungwiza, Zimbabwe
Seke South CRS
Harare, Zimbabwe