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

Sponsor
HIV Vaccine Trials Network (Other)
Overall Status
Completed
CT.gov ID
NCT04403880
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) (NIH), HIV Prevention Trials Network (Other)
759
Enrollment
53
Locations
23.3
Actual Duration (Months)
14.3
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Sample collection

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.

Study Design

Study Type:
Observational
Actual Enrollment :
759 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Characterizing SARS-CoV-2-specific Immunity in Convalescent Individuals
Actual Study Start Date :
May 13, 2020
Actual Primary Completion Date :
Apr 21, 2022
Actual Study Completion Date :
Apr 21, 2022

Arms and Interventions

Arm Intervention/Treatment
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

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

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

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

Outcome Measures

Primary Outcome Measures

  1. Humoral responses to peptide antigens derived from SARS-CoV-2 structural proteins and regions of the spike protein not present in vaccines [Measured through participant's last visit at Month 0, 2, 4, or 12]

    Measured by peptide microarray

  2. SARS-CoV-2-specific antibody binding response rate [Measured through participant's last visit at Month 0, 2, 4, or 12]

    Measured by binding antibody multiplex assay (BAMA)

  3. SARS-CoV-2-specific antibody binding response magnitude [Measured through participant's last visit at Month 0, 2, 4, or 12]

    Measured by binding antibody multiplex assay (BAMA)

  4. SARS-CoV-2-specific antibody binding response epitope specificity [Measured through participant's last visit at Month 0, 2, 4, or 12]

    Measured by binding antibody multiplex assay (BAMA)

  5. SARS-CoV-2-specific antibody neutralization response rate [Measured through participant's last visit at Month 0, 2, 4, or 12]

    Measured by neutralizing antibody assay (NAb)

  6. SARS-CoV-2-specific antibody neutralization response magnitude [Measured through participant's last visit at Month 0, 2, 4, or 12]

    Measured by neutralizing antibody assay (NAb)

  7. SARS-CoV-2-specific antibody neutralization response epitope specificity [Measured through participant's last visit at Month 0, 2, 4, or 12]

    Measured by neutralizing antibody assay (NAb)

  8. SARS-CoV-2-specific Antibody-Dependent Cellular Cytotoxicity (ADCC) response rate [Measured through participant's last visit at Month 0, 2, 4, or 12]

    Measured by antibody-dependent cellular cytotoxicity assay (ADCC)

  9. SARS-CoV-2-specific Antibody-Dependent Cellular Cytotoxicity (ADCC) response magnitude [Measured through participant's last visit at Month 0, 2, 4, or 12]

    Measured by antibody-dependent cellular cytotoxicity assay (ADCC)

  10. SARS-CoV-2-specific Antibody-Dependent Cellular Cytotoxicity (ADCC) response epitope specificity [Measured through participant's last visit at Month 0, 2, 4, or 12]

    Measured by antibody-dependent cellular cytotoxicity assay (ADCC)

  11. SARS-CoV-2-specific CD4+ and CD8+ T cell responses [Measured through participant's last visit at Month 0, 2, 4, or 12]

    Measured by flow cytometry

  12. SARS-CoV-2-specific CD4+ and CD8+ T cell response rate [Measured through participant's last visit at Month 0, 2, 4, or 12]

    Measured by flow cytometry

  13. SARS-CoV-2-specific CD4+ and CD8+ T cell response magnitude [Measured through participant's last visit at Month 0, 2, 4, or 12]

    Measured by flow cytometry

  14. SARS-CoV-2-specific CD4+ and CD8+ T cell response functional profiling [Measured through participant's last visit at Month 0, 2, 4, or 12]

    Measured by flow cytometry

  15. SARS-CoV-2-specific memory B cell characterization [Measured through participant's last visit at Month 0, 2, 4, or 12]

    Measured by phenotyping and monoclonal antibody isolation

  16. SARS-CoV-2-specific infection presentation, including clinical course, along with demographics and corresponding medical history of participants [Measured through participant's last visit at Month 0, 2, 4, or 12]

    Tabulated overall and by group

Secondary Outcome Measures

  1. Detection of viral RNA in nasopharyngeal or nasal swab samples [Measured through participant's last visit at Month 0, 2, 4, or 12]

    Measured by real-time reverse transcription polymerase chain reaction (RT-PCR) assay

  2. Response rate of SARS-CoV-2-specific binding antibodies in nasal samples [Measured through participant's last visit at Month 0, 2, 4, or 12]

    Measured by binding antibody multiplex assay (BAMA)

  3. Response magnitude of SARS-CoV-2-specific binding antibodies in nasal samples [Measured through participant's last visit at Month 0, 2, 4, or 12]

    Measured by binding antibody multiplex assay (BAMA)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alabama Vaccine CRS Birmingham Alabama United States 35294
2 UCLA CARE Center CRS Los Angeles California United States 90035
3 Bridge HIV CRS San Francisco California United States 94143
4 George Washington University CRS Washington District of Columbia United States 20037-1894
5 The Ponce de Leon Center CRS Atlanta Georgia United States 30308-2012
6 The Hope Clinic of the Emory Vaccine Center CRS Decatur Georgia United States 30030
7 Adolescent & Young Adult Research at The CORE Center (AYAR at CORE) Chicago Illinois United States 60612
8 New Orleans Adolescent Trials Unit CRS New Orleans Louisiana United States 70112
9 Johns Hopkins University CRS Baltimore Maryland United States 21205
10 Brigham and Women's Hospital Vaccine CRS (BWH VCRS) Boston Massachusetts United States 02115-6110
11 Fenway Health Clinical Research Site CRS Boston Massachusetts United States 02215-4302
12 New Jersey Medical School Clinical Research Center CRS Newark New Jersey United States 07103
13 Bronx Prevention Research Center CRS Bronx New York United States 10451
14 Harlem Prevention Center CRS New York New York United States 10027
15 Columbia P&S CRS New York New York United States 10032-3732
16 New York Blood Center CRS New York New York United States 10065
17 University of Rochester Vaccines to Prevent HIV Infection CRS Rochester New York United States 14642
18 Chapel Hill CRS Chapel Hill North Carolina United States 27599
19 Penn Prevention CRS Philadelphia Pennsylvania United States 19104
20 Vanderbilt Vaccine CRS Nashville Tennessee United States 37232-2582
21 Seattle Vaccine and Prevention CRS Seattle Washington United States 98109-1024
22 Malawi CRS Lilongwe Malawi
23 CITBM - UNIDEC, Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS Bellavista Callao Peru 15081
24 San Miguel CRS San Miguel Lima Peru 32-15088
25 Asociacion Civil Selva Amazonica (ACSA) CRS Iquitos Maynas Peru 1
26 Via Libra CRS Lima Peru 15001
27 Barranco CRS Lima Peru 15063
28 Josha Research CRS Bloemfontein South Africa
29 Emavundleni CRS Cape Town South Africa
30 Groote Schuur HIV CRS Cape Town South Africa
31 Khayelitsha CRS / (CIDRI UCT) Cape Town South Africa
32 Masiphumelele Clinical Research Site (MASI) CRS Cape Town South Africa
33 Chatsworth CRS Chatsworth South Africa
34 Botha's Hill CRS Durban South Africa
35 CAPRISA eThekwini CRS Durban South Africa
36 Vulindlela CRS Durban South Africa
37 Isipingo CRS Isipingo South Africa
38 Kliptown Soweto CRS Johannesburg South Africa
39 Soweto HVTN CRS Johannesburg South Africa
40 Aurum Institute Klerksdorp CRS Klerksdorp South Africa
41 Qhakaza Mbokodo Research Clinic CRS Ladysmith South Africa
42 Nelson Mandela Academic Research Unit CRS Mthatha South Africa
43 Synexus Stanza Clinical Research Centre CRS Pretoria South Africa
44 Rustenburg CRS Rustenburg South Africa
45 Setshaba Research Centre CRS Soshanguve South Africa
46 Tembisa Clinic 4 CRS Tembisa South Africa
47 The Aurum Institute Tembisa Clinical Research Centre CRS Tembisa South Africa
48 Tongaat CRS Tongaat South Africa
49 Verulam CRS Verulam South Africa
50 Matero Reference Clinic CRS Lusaka Zambia
51 St Mary's CRS Chitungwiza Zimbabwe
52 Zengeza CRS Chitungwiza Zimbabwe
53 Seke South CRS Harare Zimbabwe

Sponsors and Collaborators

  • HIV Vaccine Trials Network
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • HIV Prevention Trials Network

Investigators

  • Study Chair: Larry Corey, HIV Vaccine Trials Network, Fred Hutch
  • Study Chair: Shelly Karuna, HIV Vaccine Trials Network, Fred Hutch

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
HIV Vaccine Trials Network
ClinicalTrials.gov Identifier:
NCT04403880
Other Study ID Numbers:
  • HVTN 405/HPTN 1901
  • 5UM1AI068614-14
First Posted:
May 27, 2020
Last Update Posted:
May 27, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of May 27, 2022