Clinical trial NCT04403880: Characterizing SARS-CoV-2-specific Immunity in Individuals Who Have Recovered From COVID-19
Official title: Characterizing SARS-CoV-2-specific Immunity in Convalescent Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2
COVID-19
Lead sponsor: HIV Vaccine Trials Network
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: HIV Prevention Trials Network
First posted: 2020-05-27
Enrollment: 759
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Persons reporting a positive test for SARS-CoV-2 and resolution of COVID-19 within 1-8 weeks of enrollment OR, if asymptomatic infection, reporting positive SARS-CoV-2 test within 2-10 weeks of enrollment.

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.

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.

Primary outcomes:
measure: Humoral responses to peptide antigens derived from SARS-CoV-2 structural proteins and regions of the spike protein not present in vaccines
timeFrame: Measured through participant's last visit at Month 0, 2, 4, or 12
measure: SARS-CoV-2-specific antibody binding response rate
timeFrame: Measured through participant's last visit at Month 0, 2, 4, or 12
measure: SARS-CoV-2-specific antibody binding response magnitude
timeFrame: Measured through participant's last visit at Month 0, 2, 4, or 12
measure: SARS-CoV-2-specific antibody binding response epitope specificity
timeFrame: Measured through participant's last visit at Month 0, 2, 4, or 12
measure: SARS-CoV-2-specific antibody neutralization response rate
timeFrame: Measured through participant's last visit at Month 0, 2, 4, or 12
measure: SARS-CoV-2-specific antibody neutralization response magnitude
timeFrame: Measured through participant's last visit at Month 0, 2, 4, or 12
measure: SARS-CoV-2-specific antibody neutralization response epitope specificity
timeFrame: Measured through participant's last visit at Month 0, 2, 4, or 12
measure: SARS-CoV-2-specific Antibody-Dependent Cellular Cytotoxicity (ADCC) response rate
timeFrame: Measured through participant's last visit at Month 0, 2, 4, or 12
measure: SARS-CoV-2-specific Antibody-Dependent Cellular Cytotoxicity (ADCC) response magnitude
timeFrame: Measured through participant's last visit at Month 0, 2, 4, or 12
measure: SARS-CoV-2-specific Antibody-Dependent Cellular Cytotoxicity (ADCC) response epitope specificity
timeFrame: Measured through participant's last visit at Month 0, 2, 4, or 12
measure: SARS-CoV-2-specific CD4+ and CD8+ T cell responses
timeFrame: Measured through participant's last visit at Month 0, 2, 4, or 12
measure: SARS-CoV-2-specific CD4+ and CD8+ T cell response rate
timeFrame: Measured through participant's last visit at Month 0, 2, 4, or 12
measure: SARS-CoV-2-specific CD4+ and CD8+ T cell response magnitude
timeFrame: Measured through participant's last visit at Month 0, 2, 4, or 12
measure: SARS-CoV-2-specific CD4+ and CD8+ T cell response functional profiling
timeFrame: Measured through participant's last visit at Month 0, 2, 4, or 12
measure: SARS-CoV-2-specific memory B cell characterization
timeFrame: Measured through participant's last visit at Month 0, 2, 4, or 12
measure: SARS-CoV-2-specific infection presentation, including clinical course, along with demographics and corresponding medical history of participants
timeFrame: Measured through participant's last visit at Month 0, 2, 4, or 12
Secondary outcomes:
measure: Detection of viral RNA in nasopharyngeal or nasal swab samples
timeFrame: Measured through participant's last visit at Month 0, 2, 4, or 12
measure: Response rate of SARS-CoV-2-specific binding antibodies in nasal samples
timeFrame: Measured through participant's last visit at Month 0, 2, 4, or 12
measure: Response magnitude of SARS-CoV-2-specific binding antibodies in nasal samples
timeFrame: Measured through participant's last visit at Month 0, 2, 4, or 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Vaccine CRS
state: Alabama
city: Los Angeles
country: United States
facility: UCLA CARE Center CRS
state: California
city: San Francisco
country: United States
facility: Bridge HIV CRS
state: California
city: Washington
country: United States
facility: George Washington University CRS
state: District of Columbia
city: Atlanta
country: United States
facility: The Ponce de Leon Center CRS
state: Georgia
city: Decatur
country: United States
facility: The Hope Clinic of the Emory Vaccine Center CRS
state: Georgia
city: Chicago
country: United States
facility: Adolescent & Young Adult Research at The CORE Center (AYAR at CORE)
state: Illinois
city: New Orleans
country: United States
facility: New Orleans Adolescent Trials Unit CRS
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University CRS
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
state: Massachusetts
city: Boston
country: United States
facility: Fenway Health Clinical Research Site CRS
state: Massachusetts
city: Newark
country: United States
facility: New Jersey Medical School Clinical Research Center CRS
state: New Jersey
city: Bronx
country: United States
facility: Bronx Prevention Research Center CRS
state: New York
city: New York
country: United States
facility: Harlem Prevention Center CRS
state: New York
city: New York
country: United States
facility: Columbia P&S CRS
state: New York
city: New York
country: United States
facility: New York Blood Center CRS
state: New York
city: Rochester
country: United States
facility: University of Rochester Vaccines to Prevent HIV Infection CRS
state: New York
city: Chapel Hill
country: United States
facility: Chapel Hill CRS
state: North Carolina
city: Philadelphia
country: United States
facility: Penn Prevention CRS
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Vaccine CRS
state: Tennessee
city: Seattle
country: United States
facility: Seattle Vaccine and Prevention CRS
state: Washington
city: Lilongwe
country: Malawi
facility: Malawi CRS
city: Bellavista
country: Peru
facility: CITBM - UNIDEC, Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS
state: Callao
city: San Miguel
country: Peru
facility: San Miguel CRS
state: Lima
city: Iquitos
country: Peru
facility: Asociacion Civil Selva Amazonica (ACSA) CRS
state: Maynas
city: Lima
country: Peru
facility: Via Libra CRS
city: Lima
country: Peru
facility: Barranco CRS
city: Bloemfontein
country: South Africa
facility: Josha Research CRS
city: Cape Town
country: South Africa
facility: Emavundleni CRS
city: Cape Town
country: South Africa
facility: Groote Schuur HIV CRS
city: Cape Town
country: South Africa
facility: Khayelitsha CRS / (CIDRI UCT)
city: Cape Town
country: South Africa
facility: Masiphumelele Clinical Research Site (MASI) CRS
city: Chatsworth
country: South Africa
facility: Chatsworth CRS
city: Durban
country: South Africa
facility: Botha's Hill CRS
city: Durban
country: South Africa
facility: CAPRISA eThekwini CRS
city: Durban
country: South Africa
facility: Vulindlela CRS
city: Isipingo
country: South Africa
facility: Isipingo CRS
city: Johannesburg
country: South Africa
facility: Kliptown Soweto CRS
city: Johannesburg
country: South Africa
facility: Soweto HVTN CRS
city: Klerksdorp
country: South Africa
facility: Aurum Institute Klerksdorp CRS
city: Ladysmith
country: South Africa
facility: Qhakaza Mbokodo Research Clinic CRS
city: Mthatha
country: South Africa
facility: Nelson Mandela Academic Research Unit CRS
city: Pretoria
country: South Africa
facility: Synexus Stanza Clinical Research Centre CRS
city: Rustenburg
country: South Africa
facility: Rustenburg CRS
city: Soshanguve
country: South Africa
facility: Setshaba Research Centre CRS
city: Tembisa
country: South Africa
facility: Tembisa Clinic 4 CRS
city: Tembisa
country: South Africa
facility: The Aurum Institute Tembisa Clinical Research Centre CRS
city: Tongaat
country: South Africa
facility: Tongaat CRS
city: Verulam
country: South Africa
facility: Verulam CRS
city: Lusaka
country: Zambia
facility: Matero Reference Clinic CRS
city: Chitungwiza
country: Zimbabwe
facility: St Mary's CRS
city: Chitungwiza
country: Zimbabwe
facility: Zengeza CRS
city: Harare
country: Zimbabwe
facility: Seke South CRS
Study officials:
affiliation: HIV Vaccine Trials Network, Fred Hutch
name: Larry Corey
role: STUDY_CHAIR
affiliation: HIV Vaccine Trials Network, Fred Hutch
name: Shelly Karuna
role: STUDY_CHAIR
References:
citation: Karuna S, Li SS, Grant S, Walsh SR, Frank I, Casapia M, Trahey M, Hyrien O, Fisher L, Miner MD, Randhawa AK, Polakowski L, Kublin JG, Corey L, Montefiori D; HVTN 405/HPTN 1901 Study Team. Neutralizing antibody responses over time in demographically and clinically diverse individuals recovered from SARS-CoV-2 infection in the United States and Peru: A cohort study. PLoS Med. 2021 Dec 6;18(12):e1003868. doi: 10.1371/journal.pmed.1003868. eCollection 2021 Dec.