N/A
N=760
Characterizing SARS-CoV-2-specific Immunity in Individuals Who Have Recovered From COVID-19
SARS-CoV-2 · COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04403880 ↗Enrolled (actual)
760
Serious AEs
—
Results posted
Jan 2026
Primary outcome: Primary: SARS-CoV-2-specific Antibody Binding Response Rate (BAMA IgG1) by Region and Enrollment Group Among America Cohort — 15; 3; 16; 18 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Sample collection (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HIV Vaccine Trials Network
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Rate (BAMA IgG1) by Region and Enrollment Group Among America Cohort |
15; 3; 16; 18; 21; 25 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Magnitude (BAMA IgG1) by Region and Enrollment Group Among America Cohort |
10735; 5225.2; 22000; 22000; 22000; 22000 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Rate (BAMA IgG3) by Region and Enrollment Group Among America Cohort |
22; 3; 22; 21; 23; 25 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Magnitude (BAMA IgG3) by Region and Enrollment Group Among America Cohort |
4377; 7774.2; 6265.9; 5985.4; 9181.5; 12261.8 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Rate (BAMA IgA) by Region and Enrollment Group Among America Cohort |
22; 3; 23; 23; 22; 25 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Magnitude (BAMA IgA) by Region and Enrollment Group Among America Cohort |
1386.2; 1661.2; 2782.8; 3824.5; 8149.6; 9913.8 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Rate (Nab) by Region and Enrollment Group Among America Cohort |
22; 3; 23; 22; 23; 25 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Magnitude (Nab) by Region and Enrollment Group Among America Cohort |
179.3; 684.8; 328.7; 1140.6; 3636.2; 2907.6 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Rate (Nab) by Region and Enrollment Group Among Africa Cohort |
48; 11; 87; 17; 37; 13 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Magnitude (Nab) by Region and Enrollment Group Among Africa Cohort |
169; 358.7; 303.2; 478.7; 501.5; 1570.3 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Rate (ADCC) by Region and Enrollment Group Among America Cohort |
8; 2; 11; 13; 17; 17 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Magnitude (ADCC) by Region and Enrollment Group Among America Cohort |
1.5; 3.7; 5; 8.8; 12.6; 13.6 | — |
| PRIMARY SARS-CoV-2-specific CD4+ and CD8+ T Cell Response Rate (ICS) by Region and Enrollment Group Among America Cohort |
12; 3; 13; 23; 20; 25 | — |
| PRIMARY SARS-CoV-2-specific CD4+ and CD8+ T Cell Response Magnitude (ICS) by Region and Enrollment Group Among America Cohort |
0.2; 0.4; 0.4; 0.9; 0.6; 1 | — |
| PRIMARY SARS-CoV-2-specific Memory B Cell Response Magnitude (B Cell) by Region and Enrollment Group Among America Cohort |
0.01; 0.01; 0; 0.04; 0.01; 0.03 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Rate (IgG1) by Region and COVID-19 Severity Among America Cohort |
18; 46; 15; 41; 27; 39 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Magnitude (IgG1) by Region and COVID-19 Severity Among America Cohort |
5989.2; 11935.2; 22000; 22000; 22000; 2149 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Rate (IgG3) by Region and COVID-19 Severity Among America Cohort |
25; 54; 17; 41; 28; 52 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Magnitude (IgG3) by Region and COVID-19 Severity Among America Cohort |
2775.6; 5366.5; 5835.1; 11878.2; 10388.5; 3573.2 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Rate (IgA) by Region and COVID-19 Severity Among America Cohort |
25; 57; 16; 41; 28; 53 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Magnitude (IgA) by Region and COVID-19 Severity Among America Cohort |
712.6; 1591.4; 6170; 3396.5; 3914.4; 2994.4 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Rate (Nab) by Region and COVID-19 Severity Among America Cohort |
25; 56; 17; 41; 28; 54 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Magnitude (Nab) by Region and COVID-19 Severity Among America Cohort |
179.3; 527.7; 2180; 2826; 2599; 87.60 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Rate (Nab) by Region and COVID-19 Severity Among Africa Cohort |
59; 107; 19; 28; 8; 1 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Magnitude (Nab) by Region and COVID-19 Severity Among Africa Cohort |
189.0; 344.8; 422.3; 1136; 1594; 2658.5 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Rate (ADCC) by Region and COVID-19 Severity Among America Cohort |
10; 32; 8; 31; 11; 15 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Magnitude (ADCC) by Region and COVID-19 Severity Among America Cohort |
1.6; 7.7; 11.3; 13.6; 17.9; 1.1 | — |
| PRIMARY SARS-CoV-2-specific CD4+ and CD8+ T Cell Response Rate (ICS) by Region and COVID-19 Severity Among America Cohort |
15; 46; 14; 40; 28; 33 | — |
| PRIMARY SARS-CoV-2-specific CD4+ and CD8+ T Cell Response Magnitude (ICS) by Region and COVID-19 Severity Among America Cohort |
0.2; 0.6; 0.5; 1.1; 1.1; 0.3 | — |
| PRIMARY SARS-CoV-2-specific Memory B Cell Response Magnitude (B Cell) by Region and COVID-19 Severity Among America Cohort |
0.01; 0.01; 0.02; 0.02; 0.01; 0.01 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Rate (IgG1) by Region and Days Since SARS-CoV-2 Diagnosis Group Among America Cohort |
20; 60; 63; 121; 21; 57 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Magnitude (IgG1) by Region and Days Since SARS-CoV-2 Diagnosis Group Among America Cohort |
11484.4; 22000; 22000; 14553.4; 5544.1; 11097.6 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Rate (IgG3) by Region and Days Since SARS-CoV-2 Diagnosis Group Among America Cohort |
29; 73; 77; 151; 1; 19 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Magnitude (IgG3) by Region and Days Since SARS-CoV-2 Diagnosis Group Among America Cohort |
5275.2; 7354.2; 6335.5; 6180.5; 3674; 2815.5 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Rate (IgA) by Region and Days Since SARS-CoV-2 Diagnosis Group Among America Cohort |
29; 74; 80; 146; 1; 18 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Magnitude (IgA) by Region and Days Since SARS-CoV-2 Diagnosis Group Among America Cohort |
8344.8; 8379.1; 8258.5; 5754.8; 11670.8; 4340.5 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Rate (Nab) by Region and Days Since SARS-CoV-2 Diagnosis Group Among America Cohort |
21; 48; 48; 50; 29; 75 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Magnitude (Nab) by Region and Days Since SARS-CoV-2 Diagnosis Group Among America Cohort |
636.7; 2322; 1264; 574.8; 370.7; 1019 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Rate (Nab) by Region and Days Since SARS-CoV-2 Diagnosis Group Among Africa Cohort |
20; 48; 50; 101; 22; 61 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Magnitude (Nab) by Region and Days Since SARS-CoV-2 Diagnosis Group Among Africa Cohort |
341.2; 312.2; 269.1; 320.3; 341.2; 296.6 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Rate (ADCC) by Region and Days Since SARS-CoV-2 Diagnosis Group Among America Cohort |
12; 38; 33; 69; 16; 39 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Magnitude (ADCC) by Region and Days Since SARS-CoV-2 Diagnosis Group Among America Cohort |
4.1; 7.2; 5.6; 6.3; 6.5; 9.7 | — |
| PRIMARY SARS-CoV-2-specific CD4+ and CD8+ T Cell Response Rate (ICS) by Region and Days Since SARS-CoV-2 Diagnosis Group Among America Cohort |
17; 40; 41; 45; 22; 58 | — |
| PRIMARY SARS-CoV-2-specific CD4+ and CD8+ T Cell Response Magnitude (ICS) by Region and Days Since SARS-CoV-2 Diagnosis Group Among America Cohort |
0.4; 1; 0.8; 0.6; 0.4; 0.8 | — |
| PRIMARY SARS-CoV-2-specific Memory B Cell Response Magnitude (B Cell) by Region and Days Since SARS-CoV-2 Diagnosis Group Among America Cohort |
0.01; 0.01; 0.01; 0.02; 0.01; 0.01 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Rate (IgG1) by Region and Comorbidity Group Among America Cohort |
143; 104; 147; 141; 103; 95 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Magnitude (IgG1) by Region and Comorbidity Group Among America Cohort |
21989.8; 21924.8; 21849.4; 22000; 22000; 22000 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Rate (IgG3) by Region and Comorbidity Group Among America Cohort |
160; 119; 165; 157; 118; 107 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Magnitude (IgG3) by Region and Comorbidity Group Among America Cohort |
6714.8; 6505.5; 6657.1; 6717.8; 6796.4; 6335.5 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Rate (IgA) by Region and Comorbidity Group Among America Cohort |
160; 119; 167; 158; 118; 109 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Magnitude (IgA) by Region and Comorbidity Group Among America Cohort |
7557.6; 6875.2; 7658; 8354.6; 8285; 7325.5 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Rate (Nab) by Region and Comorbidity Group Among America Cohort |
301; 292; 296; 265; 191; 303 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Magnitude (Nab) by Region and Comorbidity Group Among America Cohort |
968.4; 848.1; 994.9; 961.9; 983.4; 978.7 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Rate (Nab) by Region and Comorbidity Group Among Africa Cohort |
277; 248; 255; 218; 239; 264 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Magnitude (Nab) by Region and Comorbidity Group Among Africa Cohort |
320.3; 271.3; 366.3; 278.1; 416.9; 362.2 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Rate (ADCC) by Region and Comorbidity Group Among America Cohort |
131; 138; 124; 104; 140; 93 | — |
| PRIMARY SARS-CoV-2-specific Antibody Binding Response Magnitude (ADCC) by Region and Comorbidity Group Among America Cohort |
6; 6; 4.9; 5.1; 6.6; 6.6 | — |
| PRIMARY SARS-CoV-2-specific CD4+ and CD8+ T Cell Response Rate (ICS) by Region and Comorbidity Group Among America Cohort |
139; 105; 143; 138; 104; 91 | — |
| PRIMARY SARS-CoV-2-specific CD4+ and CD8+ T Cell Response Magnitude (ICS) by Region and Comorbidity Group Among America Cohort |
0.7; 0.7; 0.7; 0.7; 0.7; 0.6 | — |
| PRIMARY SARS-CoV-2-specific Memory B Cell Response Magnitude (B Cell) by Region and Comorbidity Group Among America Cohort |
0.01; 0.01; 0.01; 0.01; 0.01; 0.01 | — |
| PRIMARY SARS-CoV-2-specific Infection Presentation, Including Clinical Course, Along With Demographics and Corresponding Medical History of Participants , Overall and by Region Among America Cohort |
14; 21; 18; 32; 20; 33 | — |
| PRIMARY SARS-CoV-2-specific Infection Presentation, Including Clinical Course, Along With Demographics and Corresponding Medical History of Participants , Overall and by Region Among Africa Cohort |
14; 12; 44; 17; 38; 20 | — |
| SECONDARY SARS-CoV-2-specific Antibody Binding Response Magnitude (IgA Nasal Sample) by Region and Enrollment Group Among America Cohort |
1.88; 2.67; 1.36; 0.2; 0.41; 1.13 | — |
| SECONDARY Detection of Viral RNA in Nasopharyngeal or Nasal Swab Samples Via RT-PCR |
5; 6; 17; 3; 11; 3 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04403880). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.