COMMUNITY - the COVID-19 Immunity Study
NCT06784739 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 5500
Last updated 2025-01-20
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
Conditions
- COVID 19
- Respiratory Synctial Virus
- Influenza Virus
- SARS-CoV-2 Virus
Interventions
- 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.
Sponsors & Collaborators
-
Danderyd Hospital
lead OTHER
Principal Investigators
-
Charlotte Thålin, MD, PhD · Department of Clinical Sciences, Karolinska Institutet Danderyd Hospital
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-04-15
- Primary Completion
- 2027-04-30
- Completion
- 2027-04-30
Countries
- Sweden
Study Locations
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