Clinical trial NCT05313087: COVID-19 Vaccine Response in Chronic Respiratory Conditions
Official title: COVID-19 Vaccine Response and Durability In Patients With Chronic Respiratory and Medical Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV Infection
Lead sponsor: National Jewish Health
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic medical conditions seen at our medical center (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

Eligibility criteria: Inclusion Criteria:

* Receipt of a SARS-CoV-2 vaccination

Exclusion Criteria:

* None

Primary outcomes:
measure: Antibody response
timeFrame: after SARS-CoV-2 vaccinations
Secondary outcomes:
measure: Antibody change
timeFrame: Change 3 months after vaccinations
measure: Antibody change
timeFrame: Change 6 months after vaccinations
measure: Antibody change
timeFrame: Change 9 months after vaccinations
measure: Antibody change
timeFrame: Change 12 months after vaccinations
measure: Antibody change
timeFrame: Change 18 months after vaccinations
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
affiliation: National Jewish Health
name: Barry Make, MD
role: PRINCIPAL_INVESTIGATOR
References: