COMMUNITY - the COVID-19 Immunity Study (COMMUNITY)

January 16, 2025 updated by: Charlotte Thålin, Danderyd Hospital

The principal aim of the COMMUNITY study is to investigate immune responses following SARS-CoV-2 infection and/or vaccination in healthcare workers and hospitalized COVID-19 patients. The study aims to enroll a total of 5,000 healthcare workers and 500 COVID-19 patients. All participants are enrolled at Danderyd Hospital in Stockholm, Sweden. Participants will be followed every four months with blood and mucosal sampling in addition to demographic and clinical data provided by the participants and from national registries.

Primary outcome:

- Antibody responses in blood and mucosa following SARS-CoV-2 infection and/or vaccination

Secondary outcomes:

  • Cellular immune responses following SARS-CoV-2 infection and/or vaccination
  • Antibody responses in blood and mucosa following following Influenza A/B infection and/or vaccination
  • Antibody responses in blood and mucosa following following RSV A/B infection

Blood and mucosal samples are collected every 4 months and at tighter intervals in sub studies. PCR testing is conducted upon symptoms of respiratory infections and with regular intervals regardless of symptomatology in sub studies. Participants provide detailed demographic and clinical data through a smart phone application-based questionnaire. Data on infection and vaccination history is collected from national registries

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The COMMUNITY study is designed to longitudinally follow healthcare workers and recovered COVID-19 patients to assess SARS-CoV-2 immune responses over time. Follow-ups are conducted every four months, including serum, PBMC, and mucosa (saliva and nasal secretions) samples. Sub studies with additional samplings and PCR screenings are conducted with regular intervals to assess vaccine responses and correlates to protection against infection.

Analyses include:

  • Quantification and characterization of antibody responses
  • Evaluation of T and B-cell responses
  • RT-qPCR detection of viral infection
  • Mucosal microbiome evaluation

Clinical and demographic data, including information on hospital workplace, exposure, immunosuppressive treatments or conditions, and results from SARS-CoV-2 Rapid Diagnostic Tests, are collected at each follow-up through a smartphone-based app system. Data on SARS-CoV-2 infections and vaccinations are obtained from national registries. In addition, data from home based PCR-screenings are continuously being monitored for SARS-CoV-2, Influenza and RSV infections.

All samples are stored in Biobank Sweden.

Study Type

Observational

Enrollment (Estimated)

5500

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 Locations

  • Sweden
      • Stockholm, Sweden, 18288
        • Recruiting
        • Danderyd Hospital
        • Contact:
      • Stockholm, Sweden, 18288
        • Recruiting
        • Karolinska Institutet Danderyd Hospital
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Danderyd Hospital employs approximately 4,500 healthcare workers. All HCWs are invited to participate in the study through information disseminated via the hospital intranet, email, and word of mouth.

Description

Inclusion Criteria:

  • Health care workers: Employment at Danderyd hospital at time of enrollment
  • COVID-19 patients: Admitted to Danderyd Hospital with confirmed SARS-CoV-2 infection at time of enrollment

Exclusion Criteria:

  • No exclusion criteria

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
Intervention / Treatment
The COMMUNITY cohort - healthcare workers
5000 healthcare workers employed at Danderyd Hospital at time of enrollment
Other: Blood sampling
Venous blood sampling
Other: Mucosal sampling
Saliva and nasal secretions
Diagnostic test: PCR-test
RT qPCR test to determine infection with SARS-CoV-2, Influenza A/B and/or RSV A/B.
The COMMUNITY cohort - COVID-19 patients
500 patients admitted to Danderyd Hospital with confirmed SARS-CoV-2 infection
Other: Blood sampling
Venous blood sampling
Other: Mucosal sampling
Saliva and nasal secretions
Diagnostic test: PCR-test
RT qPCR test to determine infection with SARS-CoV-2, Influenza A/B and/or RSV A/B.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibody responses following SARS-CoV-2 infection and/or vaccination
Time Frame: 2022-2026
Antigen-specific IgG and IgA responses in serum, saliva and nasal secretions (trajectories over time and correlates to protection against infection)
2022-2026

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibody responses following Influenza A/B infection and/or vaccination
Time Frame: 2022-2026
Antigen-specific IgG and IgA responses in serum, saliva and nasal secretions (trajectories over time and correlates to protection against infection)
2022-2026
Antibody responses following RSV infection
Time Frame: 2020-2026
Antigen-specific IgG and IgA responses in serum, saliva and nasal secretions (trajectories over time and correlates to protection against infection)
2020-2026
Cellular immune responses following SARS-CoV-2, Influenza A/B and RSV A/B infection and/or vaccination
Time Frame: 2020-2026
T and B cell responses in blood
2020-2026

Collaborators and Investigators

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

Sponsor

Danderyd Hospital

Investigators

  • Principal Investigator: Charlotte Thålin, MD, PhD, Department of Clinical Sciences, Karolinska Institutet Danderyd Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

April 15, 2020

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

January 16, 2025

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 16, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-01653 (Other Identifier: Swedish Ethical Review Authority)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Under consideration

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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