Official Title
Characterizing SARS-CoV-2-specific Immunity in Convalescent Individuals
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.

Completed
SARS-CoV-2
COVID-19

Other: Sample collection

Optional nasal specimen(s)
Blood collection

Eligibility 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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Malawi
Peru
South Africa
United States
Zambia
Zimbabwe
Locations

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

HIV Vaccine Trials Network
NCT Number
MeSH Terms
COVID-19