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COMMUNITY - the COVID-19 Immunity Study

ConditionsCOVID 19Respiratory Synctial VirusInfluenza VirusSARS-CoV-2 Virus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDanderyd Hospital

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

No exclusion criteria

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood sampling

    Other intervention

    Venous blood sampling

  • Mucosal sampling

    Other intervention

    Saliva and nasal secretions

  • PCR-test

    Diagnostic test

    RT qPCR test to determine infection with SARS-CoV-2, Influenza A/B and/or RSV A/B.

Treatment groups

5,500 Participants
are divided into 2 treatment groups
Group A: The COMMUNITY cohort - healthcare workers3 interventions
Group B: The COMMUNITY cohort - COVID-19 patients3 interventions

Trial outcomes

Primary outcomes

1

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

Antigen-specific IgG and IgA responses in serum, saliva and nasal secretions (trajectories over time and correlates to protection against infection)

Time frame
2022-2026

Secondary outcomes

1

Antibody responses following Influenza A/B infection and/or vaccination

Antigen-specific IgG and IgA responses in serum, saliva and nasal secretions (trajectories over time and correlates to protection against infection)

Time frame
2022-2026
2

Antibody responses following RSV infection

Antigen-specific IgG and IgA responses in serum, saliva and nasal secretions (trajectories over time and correlates to protection against infection)

Time frame
2020-2026
3

Cellular immune responses following SARS-CoV-2, Influenza A/B and RSV A/B infection and/or vaccination

T and B cell responses in blood

Time frame
2020-2026

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Danderyd Hospital

Lead sponsor

Karolinska Institutet

Sponsor institution

Source ClinicalTrials.gov
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