COVID-19 Vaccine Response in Chronic Respiratory Conditions

April 15, 2026 updated by: Barry Make, National Jewish Health

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Antibody response
Time Frame: after SARS-CoV-2 vaccinations
quantitative spike protein antibody, binding antibody units (BAU)
after SARS-CoV-2 vaccinations

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Antibody change
Time Frame: Change 3 months after vaccinations
Quantitative spike protein antibody, binding antibody units (BAU)
Change 3 months after vaccinations
Antibody change
Time Frame: Change 6 months after vaccinations
Quantitative spike protein antibody, binding antibody units (BAU)
Change 6 months after vaccinations
Antibody change
Time Frame: Change 9 months after vaccinations
Quantitative spike protein antibody, binding antibody units (BAU)
Change 9 months after vaccinations
Antibody change
Time Frame: Change 12 months after vaccinations
Quantitative spike protein antibody, binding antibody units (BAU)
Change 12 months after vaccinations
Antibody change
Time Frame: Change 18 months after vaccinations
Quantitative spike protein antibody, binding antibody units (BAU)
Change 18 months after vaccinations

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Jewish Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Barry Make, MD, National Jewish Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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