COVID-19 Vaccine Response in Chronic Respiratory Conditions

Recruiting

• Conditions: SARS-CoV Infection
• Interventions: Biological: COVID-19 vaccine

• Registration Number: NCT05313087
• Lead Sponsor: National Jewish Health

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

Study Timeline

• Study Start: 2021-02-03
• Study First Submitted: 2021-06-01
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-04
• Last Update Submitted: 2022-04-04
• Study First Posted: 2022-04-06
• Last Update Posted: 2022-04-06
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Receipt of a SARS-CoV-2 vaccination

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic Obstructive Pulmonary Disease (COPD	COVID-19 vaccine	Adults
Bronchiectasis	COVID-19 vaccine	Adults and children age 5 and over.
Controls - who are NOT in any of the groups listed below	COVID-19 vaccine	Adults and children age 5 and over.
Asthma - NOT receiving immunomodulator medications or chronic oral steroids	COVID-19 vaccine	Adults and children age 5 and over.
Cancer patients receiving chemotherapy	COVID-19 vaccine	Adults and children age 5 and over.
Cystic fibrosis	COVID-19 vaccine	Adults and children age 5 and over.
Previous COVID infection	COVID-19 vaccine	Adults and children age 5 and over.
Asthma receiving immunomodulator medications	COVID-19 vaccine	Adults and children age 5 and over.
Asthma receiving chronic oral steroids	COVID-19 vaccine	Adults and children age 5 and over.
Rheumatoid Arthritis receiving immunomodulator medications	COVID-19 vaccine	Adults and children age 5 and over.
Rheumatoid Arthritis NOT receiving immunomodulator medications	COVID-19 vaccine	Adults and children age 5 and over.
Interstitial lung disease	COVID-19 vaccine	Adults and children age 5 and over.

Primary Outcome Measures

Name	Time	Method
Antibody response	after SARS-CoV-2 vaccinations	quantitative spike protein antibody, binding antibody units (BAU)

Secondary Outcome Measures

Name	Time	Method
Antibody change	Change 18 months after vaccinations	Quantitative spike protein antibody, binding antibody units (BAU)

Trial Locations

Locations (1)

National Jewish Health; 🇺🇸 Denver, Colorado, United States