COVID-19 Vaccine Response in Chronic Respiratory Conditions

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

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV Infection
• Intervention / Treatment: Biological: COVID-19 vaccine

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 Type: Observational
• Enrollment (Actual): 360

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic medical conditions seen at our medical center (National Jewish Health)

Description

Inclusion Criteria:

• Receipt of a SARS-CoV-2 vaccination

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

12

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibody response	quantitative spike protein antibody, binding antibody units (BAU)	after SARS-CoV-2 vaccinations

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: National Jewish Health
• Investigators: Principal Investigator: Barry Make, MD, National Jewish Health

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2021
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: April 4, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Severe Acute Respiratory Syndrome; Biological Products; Complex Mixtures; Vaccines; Viral Vaccines; COVID-19 Vaccines
• Other Study ID Numbers: 21-08-054-528

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Results will be shared once the study results are analyzed and published.
• IPD Sharing Time Frame: Results will be shared once the study results are analyzed and published.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No