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The investigators will assess the antibody, T cell and B cell responses to SARS-CoV-2 vaccination before and every 3 months for 18 months after the initial vaccination or subsequent vaccinations (boosters) in adults and children including patients with chronic medical conditions.
HYPOTHESES
SPECIFIC AIMS
Enroll up to 1,000 patients receiving a SARS-CoV-2 vaccination (initial or subsequent vaccinations) in an observational study to determine vaccine antibody response and durability.
3. Determine the clinical features and gene expression of patients who are less responsive (have lower antibody levels and shorter duration of antibody response) to SARS-CoV-2 vaccinations.
STUDY DESIGN Patient population - up to 1,000.
Consisting of patients in the following groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controls - who are NOT in any of the groups listed below | Adults and children age 5 and over. |
| |
| Previous COVID infection | Adults and children age 5 and over. |
| |
| Asthma receiving immunomodulator medications | Adults and children age 5 and over. |
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| Asthma receiving chronic oral steroids | Adults and children age 5 and over. |
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| Asthma - NOT receiving immunomodulator medications or chronic oral steroids | Adults and children age 5 and over. |
| |
| Chronic Obstructive Pulmonary Disease (COPD | Adults |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 vaccine | Biological | assess response to vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Antibody response | quantitative spike protein antibody, binding antibody units (BAU) | after SARS-CoV-2 vaccinations |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody change | Quantitative spike protein antibody, binding antibody units (BAU) | Change 3 months after vaccinations |
| Antibody change | Quantitative spike protein antibody, binding antibody units (BAU) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic medical conditions seen at our medical center (National Jewish Health)
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| Name | Affiliation | Role |
|---|---|---|
| Barry Make, MD | National Jewish Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health | Denver | Colorado | 80206 | United States |
Results will be shared once the study results are analyzed and published.
Results will be shared once the study results are analyzed and published.
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| ID | Term |
|---|---|
| D045169 | Severe Acute Respiratory Syndrome |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
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| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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DNA, RNA, serum, plasma
| Rheumatoid Arthritis receiving immunomodulator medications | Adults and children age 5 and over. |
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| Rheumatoid Arthritis NOT receiving immunomodulator medications | Adults and children age 5 and over. |
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| Interstitial lung disease | Adults and children age 5 and over. |
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| Cancer patients receiving chemotherapy | Adults and children age 5 and over. |
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| Bronchiectasis | Adults and children age 5 and over. |
|
| Cystic fibrosis | Adults and children age 5 and over. |
|
| Change 6 months after vaccinations |
| Antibody change | Quantitative spike protein antibody, binding antibody units (BAU) | Change 9 months after vaccinations |
| Antibody change | Quantitative spike protein antibody, binding antibody units (BAU) | Change 12 months after vaccinations |
| Antibody change | Quantitative spike protein antibody, binding antibody units (BAU) | Change 18 months after vaccinations |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |