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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
HIV Vaccine Trials Network
Study ID
NCT04403880
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Sample collection — OTHER
    * Optional nasal specimen(s) * Blood collection

Study Details

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 Dates

Start date
May 13, 2020
Status verified
Dec 2025
Primary completion
Apr 21, 2022
Completion
Apr 21, 2022

Study Design

Enrollment
760 participants (actual)

Arms

  • Arm: Group 1
    Persons not hospitalized for COVID-19, without clinical spectrum or outcomes specified in group 3 * 1A: Persons with asymptomatic infection, ages 18 through 55, inclusive * 1B: Persons with asymptomatic infection, age \> 55 * 1C: Persons with symptomatic infection (ie, COVID-19) ages 18 through 55 * 1D: Persons with symptomatic infection (ie, COVID-19), age \> 55
  • Arm: Group 2
    Persons previously hospitalized for COVID-19, without clinical spectrum or outcomes specified in group 3 * 2A: Persons 18 through 55 years of age * 2B: Persons \> 55 years of age
  • Arm: Group 3
    Persons with specific clinical spectrums or outcomes, regardless of hospitalization history (eg, persons recovered after intubation, with prolonged viral shedding, with myocarditis/pericarditis, with rapid recovery from COVID-19, with a second positive SARS-CoV-2 RT-PCR test result after a negative result)

Primary Outcome Measure

SARS-CoV-2-specific Antibody Binding Response Rate (BAMA IgG1) by Region and Enrollment Group Among America Cohort [ Time Frame: Measured at Months 0, 2, 4 ]

Locations (21)

FacilityCityStateZIPSite coordinators
Alabama Vaccine CRSBirminghamAlabama35294-
UCLA CARE Center CRSLos AngelesCalifornia90035-
Bridge HIV CRSSan FranciscoCalifornia94143-
George Washington University CRSWashington D.C.District of Columbia20037-1894-
The Ponce de Leon Center CRSAtlantaGeorgia30308-2012-
The Hope Clinic of the Emory Vaccine Center CRSDecaturGeorgia30030-
Adolescent & Young Adult Research at The CORE Center (AYAR at CORE)ChicagoIllinois60612-
New Orleans Adolescent Trials Unit CRSNew OrleansLouisiana70112-
Johns Hopkins University CRSBaltimoreMaryland21205-
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)BostonMassachusetts02115-6110-
Fenway Health Clinical Research Site CRSBostonMassachusetts02215-4302-
New Jersey Medical School Clinical Research Center CRSNewarkNew Jersey07103-
Columbia P&S CRSNew YorkNew York10032-3732-
Harlem Prevention Center CRSNew YorkNew York10027-
New York Blood Center CRSNew YorkNew York10065-
University of Rochester Vaccines to Prevent HIV Infection CRSRochesterNew York14642-
Bronx Prevention Research Center CRSThe BronxNew York10451-
Chapel Hill CRSChapel HillNorth Carolina27599-
Penn Prevention CRSPhiladelphiaPennsylvania19104-
Vanderbilt Vaccine CRSNashvilleTennessee37232-2582-
Seattle Vaccine and Prevention CRSSeattleWashington98109-1024-

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