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NCT Number: NCT06784739

COMMUNITY - the COVID-19 Immunity Study

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

Recruiting

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Key information

Conditions

COVID 19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Influenza Virus Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Synctial Virus Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV-2 Virus Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Danderyd hospital, Stockholm, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Other

Venous blood sampling

Mucosal sampling

Other

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Nina Greilert Norin, RN

CONTACT

[email protected]

+ 46812355000

Sponsors and collaborators

Lead sponsor

Danderyd Hospital

Other

Registry information

Acronym: COMMUNITY

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2025
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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