COVID-19 Vaccine Response in Chronic Respiratory Conditions

SARS-CoV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05313087
• Other study ID #: 21-08-054-528
• Status: Recruiting
• Start date: February 3, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2022
• Source: National Jewish Health
• Contact: Barry Make, MD
• Phone: 303-398-1993
• Email: makeb[@]njhealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Receipt of a SARS-CoV-2 vaccination

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Biological:
• COVID-19 vaccine
assess response to vaccine

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
National Jewish Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody response	quantitative spike protein antibody, binding antibody units (BAU)	after SARS-CoV-2 vaccinations
Secondary	Antibody change	Quantitative spike protein antibody, binding antibody units (BAU)	Change 3 months after vaccinations
Secondary	Antibody change	Quantitative spike protein antibody, binding antibody units (BAU)	Change 6 months after vaccinations
Secondary	Antibody change	Quantitative spike protein antibody, binding antibody units (BAU)	Change 9 months after vaccinations
Secondary	Antibody change	Quantitative spike protein antibody, binding antibody units (BAU)	Change 12 months after vaccinations
Secondary	Antibody change	Quantitative spike protein antibody, binding antibody units (BAU)	Change 18 months after vaccinations