COMMUNITY - the COVID-19 Immunity Study

Обзор

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

Подробное описание

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.

Вмешательства

• Другое Blood sampling
  Venous blood sampling
• Другое Mucosal sampling
  Saliva and nasal secretions
• Диагностический тест PCR-test
  RT qPCR test to determine infection with SARS-CoV-2, Influenza A/B and/or RSV A/B.

Первичные конечные точки

• Antibody responses following SARS-CoV-2 infection and/or vaccination [Срок оценки: 2022-2026]

Вторичные конечные точки (3)

• Antibody responses following Influenza A/B infection and/or vaccination [Срок оценки: 2022-2026]
• Antibody responses following RSV infection [Срок оценки: 2020-2026]
• Cellular immune responses following SARS-CoV-2, Influenza A/B and RSV A/B infection and/or vaccination [Срок оценки: 2020-2026]

Критерии участия

Критерии включения

• 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

Критерии исключения

• No exclusion criteria

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швеция · 2 центра

• Danderyd hospital — Stockholm
• Karolinska Institutet Danderyd Hospital — Stockholm

Публикации

• 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. PMID 33267662
• 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. PMID 37012986
• 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, Shoema PMID 35781796
• 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. PMID 34628049
• 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-1 PMID 35020778
• 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. PMID 34731533
• 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. PMID 37680234
• 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. PMID 33560386

Идентификаторы

NCT: NCT06784739 · 2020-01653 · 2020-01653

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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