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COMMUNITY - the COVID-19 Immunity Study

COMMUNITY - the COVID-19 Immunity Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06784739
Acronym
COMMUNITY
Enrollment
5500
Registered
2025-01-20
Start date
2020-04-15
Completion date
2027-04-30
Last updated
2025-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID 19, Influenza Virus, Respiratory Synctial Virus, SARS-CoV-2 Virus

Keywords

COVID-19, Mucosal immunity, Pandemic, Vaccination, Secretory IgA

Brief summary

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

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.

Interventions

OTHERBlood sampling

Venous blood sampling

OTHERMucosal sampling

Saliva and nasal secretions

DIAGNOSTIC_TESTPCR-test

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

Sponsors

Danderyd Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Antibody responses following SARS-CoV-2 infection and/or vaccination2022-2026Antigen-specific IgG and IgA responses in serum, saliva and nasal secretions (trajectories over time and correlates to protection against infection)

Secondary

MeasureTime frameDescription
Antibody responses following Influenza A/B infection and/or vaccination2022-2026Antigen-specific IgG and IgA responses in serum, saliva and nasal secretions (trajectories over time and correlates to protection against infection)
Antibody responses following RSV infection2020-2026Antigen-specific IgG and IgA responses in serum, saliva and nasal secretions (trajectories over time and correlates to protection against infection)
Cellular immune responses following SARS-CoV-2, Influenza A/B and RSV A/B infection and/or vaccination2020-2026T and B cell responses in blood

Countries

Sweden

Contacts

Primary ContactNina Greilert Norin, RN
nina.greilert@ki.se+ 46812355000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026