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

COVID-19 Clinical Trial

Official title:

Characterizing SARS-CoV-2-specific Immunity in Convalescent Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04403880
• Other study ID #: HVTN 405/HPTN 1901
• Secondary ID: 5UM1AI068614-14
• Status: Completed
• Start date: May 13, 2020
• Est. completion date: April 21, 2022

Study information

• Verified date: May 2022
• Source: HIV Vaccine Trials Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 759
• Est. completion date: April 21, 2022
• Est. primary completion date: April 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (ß-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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2

Intervention

Other:
• Sample collection
Optional nasal specimen(s) Blood collection

Locations

Country	Name	City	State
Malawi	Malawi CRS	Lilongwe
Peru	CITBM - UNIDEC, Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS	Bellavista	Callao
Peru	Asociacion Civil Selva Amazonica (ACSA) CRS	Iquitos	Maynas
Peru	Barranco CRS	Lima
Peru	Via Libra CRS	Lima
Peru	San Miguel CRS	San Miguel	Lima
South Africa	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
United States	The Ponce de Leon Center CRS	Atlanta	Georgia
United States	Johns Hopkins University CRS	Baltimore	Maryland
United States	Alabama Vaccine CRS	Birmingham	Alabama
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	Bronx Prevention Research Center CRS	Bronx	New York
United States	Chapel Hill CRS	Chapel Hill	North Carolina
United States	Adolescent & Young Adult Research at The CORE Center (AYAR at CORE)	Chicago	Illinois
United States	The Hope Clinic of the Emory Vaccine Center CRS	Decatur	Georgia
United States	UCLA CARE Center CRS	Los Angeles	California
United States	Vanderbilt Vaccine CRS	Nashville	Tennessee
United States	New Orleans Adolescent Trials Unit CRS	New Orleans	Louisiana
United States	Columbia P&S CRS	New York	New York
United States	Harlem Prevention Center CRS	New York	New York
United States	New York Blood Center CRS	New York	New York
United States	New Jersey Medical School Clinical Research Center CRS	Newark	New Jersey
United States	Penn Prevention CRS	Philadelphia	Pennsylvania
United States	University of Rochester Vaccines to Prevent HIV Infection CRS	Rochester	New York
United States	Bridge HIV CRS	San Francisco	California
United States	Seattle Vaccine and Prevention CRS	Seattle	Washington
United States	George Washington University CRS	Washington	District of Columbia
Zambia	Matero Reference Clinic CRS	Lusaka
Zimbabwe	St Mary's CRS	Chitungwiza
Zimbabwe	Zengeza CRS	Chitungwiza
Zimbabwe	Seke South CRS	Harare

Sponsors (3)

Lead Sponsor	Collaborator
HIV Vaccine Trials Network	HIV Prevention Trials Network, National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Zambia,  Zimbabwe,  Malawi,  Peru,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Humoral responses to peptide antigens derived from SARS-CoV-2 structural proteins and regions of the spike protein not present in vaccines	Measured by peptide microarray	Measured through participant's last visit at Month 0, 2, 4, or 12
Primary	SARS-CoV-2-specific antibody binding response rate	Measured by binding antibody multiplex assay (BAMA)	Measured through participant's last visit at Month 0, 2, 4, or 12
Primary	SARS-CoV-2-specific antibody binding response magnitude	Measured by binding antibody multiplex assay (BAMA)	Measured through participant's last visit at Month 0, 2, 4, or 12
Primary	SARS-CoV-2-specific antibody binding response epitope specificity	Measured by binding antibody multiplex assay (BAMA)	Measured through participant's last visit at Month 0, 2, 4, or 12
Primary	SARS-CoV-2-specific antibody neutralization response rate	Measured by neutralizing antibody assay (NAb)	Measured through participant's last visit at Month 0, 2, 4, or 12
Primary	SARS-CoV-2-specific antibody neutralization response magnitude	Measured by neutralizing antibody assay (NAb)	Measured through participant's last visit at Month 0, 2, 4, or 12
Primary	SARS-CoV-2-specific antibody neutralization response epitope specificity	Measured by neutralizing antibody assay (NAb)	Measured through participant's last visit at Month 0, 2, 4, or 12
Primary	SARS-CoV-2-specific Antibody-Dependent Cellular Cytotoxicity (ADCC) response rate	Measured by antibody-dependent cellular cytotoxicity assay (ADCC)	Measured through participant's last visit at Month 0, 2, 4, or 12
Primary	SARS-CoV-2-specific Antibody-Dependent Cellular Cytotoxicity (ADCC) response magnitude	Measured by antibody-dependent cellular cytotoxicity assay (ADCC)	Measured through participant's last visit at Month 0, 2, 4, or 12
Primary	SARS-CoV-2-specific Antibody-Dependent Cellular Cytotoxicity (ADCC) response epitope specificity	Measured by antibody-dependent cellular cytotoxicity assay (ADCC)	Measured through participant's last visit at Month 0, 2, 4, or 12
Primary	SARS-CoV-2-specific CD4+ and CD8+ T cell responses	Measured by flow cytometry	Measured through participant's last visit at Month 0, 2, 4, or 12
Primary	SARS-CoV-2-specific CD4+ and CD8+ T cell response rate	Measured by flow cytometry	Measured through participant's last visit at Month 0, 2, 4, or 12
Primary	SARS-CoV-2-specific CD4+ and CD8+ T cell response magnitude	Measured by flow cytometry	Measured through participant's last visit at Month 0, 2, 4, or 12
Primary	SARS-CoV-2-specific CD4+ and CD8+ T cell response functional profiling	Measured by flow cytometry	Measured through participant's last visit at Month 0, 2, 4, or 12
Primary	SARS-CoV-2-specific memory B cell characterization	Measured by phenotyping and monoclonal antibody isolation	Measured through participant's last visit at Month 0, 2, 4, or 12
Primary	SARS-CoV-2-specific infection presentation, including clinical course, along with demographics and corresponding medical history of participants	Tabulated overall and by group	Measured through participant's last visit at Month 0, 2, 4, or 12
Secondary	Detection of viral RNA in nasopharyngeal or nasal swab samples	Measured by real-time reverse transcription polymerase chain reaction (RT-PCR) assay	Measured through participant's last visit at Month 0, 2, 4, or 12
Secondary	Response rate of SARS-CoV-2-specific binding antibodies in nasal samples	Measured by binding antibody multiplex assay (BAMA)	Measured through participant's last visit at Month 0, 2, 4, or 12
Secondary	Response magnitude of SARS-CoV-2-specific binding antibodies in nasal samples	Measured by binding antibody multiplex assay (BAMA)	Measured through participant's last visit at Month 0, 2, 4, or 12