NCT05313087

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2021

Completed
10 months until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

2.9 years

First QC Date

June 1, 2021

Last Update Submit

April 15, 2026

Conditions

SARS-CoV Infection

Outcome Measures

Primary Outcomes (1)

  • Antibody response

    quantitative spike protein antibody, binding antibody units (BAU)

    after SARS-CoV-2 vaccinations

Secondary Outcomes (5)

  • Antibody change

    Change 3 months after vaccinations

  • Antibody change

    Change 6 months after vaccinations

  • Antibody change

    Change 9 months after vaccinations

  • Antibody change

    Change 12 months after vaccinations

  • Antibody change

    Change 18 months after vaccinations

Study Arms (12)

Controls - who are NOT in any of the groups listed below

Adults and children age 5 and over.

Biological: COVID-19 vaccine

Previous COVID infection

Adults and children age 5 and over.

Biological: COVID-19 vaccine

Asthma receiving immunomodulator medications

Adults and children age 5 and over.

Biological: COVID-19 vaccine

Asthma receiving chronic oral steroids

Adults and children age 5 and over.

Biological: COVID-19 vaccine

Asthma - NOT receiving immunomodulator medications or chronic oral steroids

Adults and children age 5 and over.

Biological: COVID-19 vaccine

Chronic Obstructive Pulmonary Disease (COPD

Adults

Biological: COVID-19 vaccine

Rheumatoid Arthritis receiving immunomodulator medications

Adults and children age 5 and over.

Biological: COVID-19 vaccine

Rheumatoid Arthritis NOT receiving immunomodulator medications

Adults and children age 5 and over.

Biological: COVID-19 vaccine

Interstitial lung disease

Adults and children age 5 and over.

Biological: COVID-19 vaccine

Cancer patients receiving chemotherapy

Adults and children age 5 and over.

Biological: COVID-19 vaccine

Bronchiectasis

Adults and children age 5 and over.

Biological: COVID-19 vaccine

Cystic fibrosis

Adults and children age 5 and over.

Biological: COVID-19 vaccine

Interventions

COVID-19 vaccineBIOLOGICAL

assess response to vaccine

Asthma - NOT receiving immunomodulator medications or chronic oral steroidsAsthma receiving chronic oral steroidsAsthma receiving immunomodulator medicationsBronchiectasisCancer patients receiving chemotherapyChronic Obstructive Pulmonary Disease (COPDControls - who are NOT in any of the groups listed belowCystic fibrosisInterstitial lung diseasePrevious COVID infectionRheumatoid Arthritis NOT receiving immunomodulator medicationsRheumatoid Arthritis receiving immunomodulator medications

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Receipt of a SARS-CoV-2 vaccination

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA, RNA, serum, plasma

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Barry Make, MD

    National Jewish Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

June 1, 2021

First Posted

April 6, 2022

Study Start

February 3, 2021

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Results will be shared once the study results are analyzed and published.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Results will be shared once the study results are analyzed and published.

Locations

US(1)