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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-01653 | Other Identifier | Swedish Ethical Review Authority |
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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:
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
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The COMMUNITY cohort - healthcare workers | 5000 healthcare workers employed at Danderyd Hospital at time of enrollment |
| |
| The COMMUNITY cohort - COVID-19 patients | 500 patients admitted to Danderyd Hospital with confirmed SARS-CoV-2 infection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Other | Venous blood sampling |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 2022-2026 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 2022-2026 |
| Antibody responses following RSV infection |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nina Greilert Norin, RN | Contact | + 46812355000 | nina.greilert@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Charlotte Thålin, MD, PhD | Department of Clinical Sciences, Karolinska Institutet Danderyd Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danderyd hospital | Recruiting | Stockholm | 18288 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33267662 | Background | Ng H, Havervall S, Rosell A, Aguilera K, Parv K, von Meijenfeldt FA, Lisman T, Mackman N, Thalin C, Phillipson M. Circulating Markers of Neutrophil Extracellular Traps Are of Prognostic Value in Patients With COVID-19. Arterioscler Thromb Vasc Biol. 2021 Feb;41(2):988-994. doi: 10.1161/ATVBAHA.120.315267. Epub 2020 Dec 3. | |
| 37012986 |
| Label | URL |
|---|---|
| Charlotte Thålin Group at KI | View source |
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Under consideration
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Serum, PBMC, saliva, nasal secretions
| 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. |
|
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 | T and B cell responses in blood | 2020-2026 |
| Karolinska Institutet Danderyd Hospital | Recruiting | Stockholm | 18288 | Sweden |
|
| Sachetto ATA, Archibald SJ, Hisada Y, Rosell A, Havervall S, van Es N, Nieuwland R, Campbell RA, Middleton EA, Rondina MT, Thalin C, Mackman N. Tissue factor activity of small and large extracellular vesicles in different diseases. Res Pract Thromb Haemost. 2023 Mar;7(3):100124. doi: 10.1016/j.rpth.2023.100124. Epub 2023 Mar 15. |
| 35781796 | Background | Monteil V, Eaton B, Postnikova E, Murphy M, Braunsfeld B, Crozier I, Kricek F, Niederhofer J, Schwarzbock A, Breid H, Devignot S, Klingstrom J, Thalin C, Kellner MJ, Christ W, Havervall S, Mereiter S, Knapp S, Sanchez Jimenez A, Bugajska-Schretter A, Dohnal A, Ruf C, Gugenberger R, Hagelkruys A, Montserrat N, Kozieradzki I, Hasan Ali O, Stadlmann J, Holbrook MR, Schmaljohn C, Oostenbrink C, Shoemaker RH, Mirazimi A, Wirnsberger G, Penninger JM. Clinical grade ACE2 as a universal agent to block SARS-CoV-2 variants. EMBO Mol Med. 2022 Aug 8;14(8):e15230. doi: 10.15252/emmm.202115230. Epub 2022 Jul 4. |
| 34628049 | Background | Mravinacova S, Jonsson M, Christ W, Klingstrom J, Yousef J, Hellstrom C, Hedhammar M, Havervall S, Thalin C, Pin E, Tegel H, Nilsson P, Manberg A, Hober S. A cell-free high throughput assay for assessment of SARS-CoV-2 neutralizing antibodies. N Biotechnol. 2022 Jan 25;66:46-52. doi: 10.1016/j.nbt.2021.10.002. Epub 2021 Oct 7. |
| 35020778 | Result | Havervall S, Jernbom Falk A, Klingstrom J, Ng H, Greilert-Norin N, Gabrielsson L, Salomonsson AC, Isaksson E, Rudberg AS, Hellstrom C, Andersson E, Olofsson J, Skoglund L, Yousef J, Pin E, Christ W, Olausson M, Hedhammar M, Tegel H, Mangsbo S, Phillipson M, Manberg A, Hober S, Nilsson P, Thalin C. SARS-CoV-2 induces a durable and antigen specific humoral immunity after asymptomatic to mild COVID-19 infection. PLoS One. 2022 Jan 12;17(1):e0262169. doi: 10.1371/journal.pone.0262169. eCollection 2022. |
| 34731533 | Result | von Meijenfeldt FA, Havervall S, Adelmeijer J, Thalin C, Lisman T. Persistent endotheliopathy in the pathogenesis of long COVID syndrome: Comment from von Meijenfeldt et al. J Thromb Haemost. 2022 Jan;20(1):267-269. doi: 10.1111/jth.15580. Epub 2021 Nov 22. No abstract available. |
| 37680234 | Result | Blom K, Bladh O, Havervall S, Marking U, Greilert Norin N, Alm JJ, Klingstrom J, Thalin C. Point prevalence of SARS-CoV-2 infection among healthcare workers in March and June 2023 in Sweden. Lancet Reg Health Eur. 2023 Aug 30;33:100725. doi: 10.1016/j.lanepe.2023.100725. eCollection 2023 Oct. No abstract available. |
| 33560386 | Result | von Meijenfeldt FA, Havervall S, Adelmeijer J, Lundstrom A, Magnusson M, Mackman N, Thalin C, Lisman T. Sustained prothrombotic changes in COVID-19 patients 4 months after hospital discharge. Blood Adv. 2021 Feb 9;5(3):756-759. doi: 10.1182/bloodadvances.2020003968. No abstract available. |
| 33825846 | Result | Havervall S, Rosell A, Phillipson M, Mangsbo SM, Nilsson P, Hober S, Thalin C. Symptoms and Functional Impairment Assessed 8 Months After Mild COVID-19 Among Health Care Workers. JAMA. 2021 May 18;325(19):2015-2016. doi: 10.1001/jama.2021.5612. |
| 35691303 | Result | Blom K, Marking U, Havervall S, Norin NG, Gordon M, Garcia M, Tecleab T, Christ W, Forsell M, Phillipson M, Nilsson P, Mangsbo S, Hober S, Aberg M, Klingstrom J, Thalin C. Immune responses after omicron infection in triple-vaccinated health-care workers with and without previous SARS-CoV-2 infection. Lancet Infect Dis. 2022 Jul;22(7):943-945. doi: 10.1016/S1473-3099(22)00362-0. Epub 2022 Jun 9. No abstract available. |
| 35444806 | Result | Havervall S, Marking U, Greilert-Norin N, Gordon M, Ng H, Christ W, Phillipson M, Nilsson P, Hober S, Blom K, Klingstrom J, Mangsbo S, Aberg M, Thalin C. Impact of SARS-CoV-2 infection on vaccine-induced immune responses over time. Clin Transl Immunology. 2022 Apr 18;11(4):e1388. doi: 10.1002/cti2.1388. eCollection 2022. |
| 33742434 | Result | von Meijenfeldt FA, Havervall S, Adelmeijer J, Lundstrom A, Magnusson M, Mackman N, Thalin C, Lisman T. COVID-19 is Associated with an Acquired Factor XIII Deficiency. Thromb Haemost. 2021 Dec;121(12):1668-1669. doi: 10.1055/a-1450-8414. Epub 2021 May 5. No abstract available. |
| 35997692 | Result | Blom K, Havervall S, Marking U, Norin NG, Bacchus P, Groenheit R, Brave A, Thalin C, Klingstrom J. Infection Rate of SARS-CoV-2 in Asymptomatic Healthcare Workers, Sweden, June 2022. Emerg Infect Dis. 2022 Oct;28(10):2119-2121. doi: 10.3201/eid2810.221093. Epub 2022 Aug 23. |
| 38558811 | Result | Bladh O, Aguilera K, Marking U, Kihlgren M, Greilert Norin N, Smed-Sorensen A, Sallberg Chen M, Klingstrom J, Blom K, Russell MW, Havervall S, Thalin C, Aberg M. Comparison of SARS-CoV-2 spike-specific IgA and IgG in nasal secretions, saliva and serum. Front Immunol. 2024 Mar 15;15:1346749. doi: 10.3389/fimmu.2024.1346749. eCollection 2024. |
| 37086736 | Result | Bladh O, Marking U, Havervall S, Norin NG, Aguilera K, Hober S, Smed-Sorensen A, Gordon M, Blom K, Aberg M, Klingstrom J, Thalin C. Mucosal immune responses following a fourth SARS-CoV-2 vaccine dose. Lancet Microbe. 2023 Jul;4(7):e488. doi: 10.1016/S2666-5247(23)00102-7. Epub 2023 Apr 20. No abstract available. |
| 37453441 | Result | Marking U, Bladh O, Havervall S, Greilert-Norin N, Gordon M, Alm JJ, Blom K, Aberg M, Klingstrom J, Thalin C. Mucosal IgA protects against BQ.1 and BQ.1.1 infection. Lancet Infect Dis. 2023 Aug;23(8):e272-e273. doi: 10.1016/S1473-3099(23)00421-8. Epub 2023 Jul 12. No abstract available. |
| 36103621 | Result | Havervall S, Marking U, Svensson J, Greilert-Norin N, Bacchus P, Nilsson P, Hober S, Gordon M, Blom K, Klingstrom J, Aberg M, Smed-Sorensen A, Thalin C. Anti-Spike Mucosal IgA Protection against SARS-CoV-2 Omicron Infection. N Engl J Med. 2022 Oct 6;387(14):1333-1336. doi: 10.1056/NEJMc2209651. Epub 2022 Sep 14. No abstract available. |
| 38190833 | Result | Marking U, Bladh O, Aguilera K, Yang Y, Greilert Norin N, Blom K, Hober S, Klingstrom J, Havervall S, Aberg M, Sheward DJ, Thalin C. Humoral immune responses to the monovalent XBB.1.5-adapted BNT162b2 mRNA booster in Sweden. Lancet Infect Dis. 2024 Feb;24(2):e80-e81. doi: 10.1016/S1473-3099(23)00779-X. Epub 2024 Jan 5. No abstract available. |
| 37888924 | Result | Bladh O, Greilert-Norin N, Havervall S, Marking U, Aguilera K, Alm JJ, Blom K, Aberg M, Klingstrom J, Thalin C. Mucosal and Serum Antibodies 3 Weeks after Symptomatic BA.2.86 Infection. N Engl J Med. 2023 Oct 26;389(17):1626-1628. doi: 10.1056/NEJMc2310347. No abstract available. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |