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COVID-19 Vaccine Response in Chronic Respiratory Conditions

COVID-19 Vaccine Response and Durability In Patients With Chronic Respiratory and Medical Disorders

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05313087
Enrollment
360
Registered
2022-04-06
Start date
2021-02-03
Completion date
2023-12-30
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV Infection

Brief summary

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.

Detailed description

HYPOTHESES 1. Patients with chronic respiratory diseases will have a lower antibody response to SARS-CoV-2 virus after vaccination and shorter durability of the response than control subjects without chronic disorders. 2. Patients on corticosteroids and other immunomodulator medications for chronic medical disorders will have a lower antibody response to SARS-CoV-2 after vaccination and shorter durability of the response than subjects with chronic disorders who are not being treated with corticosteroids and immunomodulator medications. SPECIFIC AIMS 1. 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. 1. Obtain blood samples to measure antibody 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) . 2. Categorize patients by their age, gender, race, ethnicity, underlying chronic disease, disease severity, medical therapy and comorbidities. 3. Assess the clinical effectiveness of the vaccine to prevent COVID-19 infections. 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: 1. Controls - who are NOT in any of the groups listed below. 2. Previous COVID infection 3. Asthma receiving immunomodulator medications 4. Asthma receiving chronic oral steroids 5. Asthma - NOT receiving immunomodulator medications or chronic oral steroids 6. Chronic Obstructive Pulmonary Disease (COPD) 7. Rheumatoid Arthritis receiving immunomodulator medications 8. Rheumatoid Arthritis NOT receiving immunomodulator medications 9. Interstitial lung disease 10. Cancer patients receiving chemotherapy 11. Bronchiectasis 12. Cystic fibrosis

Interventions

BIOLOGICALCOVID-19 vaccine

assess response to vaccine

Sponsors

National Jewish Health
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Receipt of a SARS-CoV-2 vaccination

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Antibody responseafter SARS-CoV-2 vaccinationsquantitative spike protein antibody, binding antibody units (BAU)

Secondary

MeasureTime frameDescription
Antibody changeChange 3 months after vaccinationsQuantitative spike protein antibody, binding antibody units (BAU)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORBarry Make, MD

National Jewish Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026