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| Name | Class |
|---|---|
| Haukeland University Hospital | OTHER |
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The ongoing Coronavirus Disease 2019 (COVID-19) pandemic has been intensified by no population-based immunity to the severe acute respiratory disease coronavirus 2 (SARS-CoV2) and initially lack of effective treatments or vaccines available to mitigate the pandemic. Currently, two COVID-19 vaccines are available for vaccination in Europe through conditional marketing authorisation granted by the European Medicines Agency and further vaccine will be licensed. These vaccines have shown good vaccine efficacy in phase 3 vaccine trials. We will recruit subjects who will be prioritised for vaccination with the primary aim of comparing the immune responses after COVID-19 vaccination and natural SARS-CoV-2 infection. In Western Norway we have recruited cohorts of health care workers and patients infected with SARS-CoV-2 and will extend to COVID-19 vaccinees. Demographic, clinical data and repeated blood samples will be collected to evaluate the complications and kinetics, duration and breadth of the immune responses comparing natural infection to vaccination.
The primary aim of this study is
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health care workers | 500-1000 health care workers prioritized for early vaccination |
| |
| prioritized patient populations | 2000 individuals in patient populations prioritized for vaccinations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| covid-19 vaccine | Biological | vaccination |
|
| Measure | Description | Time Frame |
|---|---|---|
| immune responses | spike antibody response to SARS-CoV-2 | 2 months to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration and breadth of B- cell responses | compare serological and memory B cells after vaccination to natural infection | 2 months to 3 years |
| Duration and breadth of T cell responses | compare T cell responses after vaccination to natural infection |
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Inclusion Criteria:
Exclusion Criteria:
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Comparator group: patients with natural SARS-CoV-2 infection Vaccine groups: Health care workers and high-risk population groups.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecca J Cox, PhD | Contact | +4745242974 | rebecca.cox@uib.no | |
| Nina Langeland, MD | Contact | +4741616450 | nina.langeland@uib.no |
| Name | Affiliation | Role |
|---|---|---|
| Rebecca J Cox, PhD | University of Bergen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bergen | Recruiting | Bergen | 5020 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32553187 | Background | Cox RJ, Brokstad KA, Krammer F, Langeland N; Bergen COVID-19 Research Group. Seroconversion in household members of COVID-19 outpatients. Lancet Infect Dis. 2021 Feb;21(2):168. doi: 10.1016/S1473-3099(20)30466-7. Epub 2020 Jun 15. No abstract available. | |
| 33247924 | Background | Trieu MC, Bansal A, Madsen A, Zhou F, Saevik M, Vahokoski J, Brokstad KA, Krammer F, Tondel C, Mohn KGI, Blomberg B, Langeland N, Cox RJ; Bergen COVID-19 Research Group. SARS-CoV-2-Specific Neutralizing Antibody Responses in Norwegian Health Care Workers After the First Wave of COVID-19 Pandemic: A Prospective Cohort Study. J Infect Dis. 2021 Feb 24;223(4):589-599. doi: 10.1093/infdis/jiaa737. |
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To be developed
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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 |
|---|---|
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Blood collection including cells.
| 2 months to 3 years |
| 39403561 | Derived | Bredholt G, Saevik M, Soyland H, Ueland T, Zhou F, Pathirana R, Madsen A, Vahokoski J, Lartey S, Halvorsen BE, Dahl TB, Trieu MC, Mohn KG, Brokstad KA, Aukrust P, Tondel C, Langeland N, Blomberg B, Cox RJ; Bergen COVID-19 Research Group. Three doses of Sars-CoV-2 mRNA vaccine in older adults result in similar antibody responses but reduced cellular cytokine responses relative to younger adults. Vaccine X. 2024 Sep 25;20:100564. doi: 10.1016/j.jvacx.2024.100564. eCollection 2024 Oct. |
| 36643855 | Derived | Hansen L, Brokstad KA, Bansal A, Zhou F, Bredholt G, Onyango TB, Sandnes HH, Elyanow R, Madsen A, Trieu MC, Saevik M, Soyland H, Olofsson JS, Vahokoski J, Ertesvag NU, Fjelltveit EB, Shafiani S, Tondel C, Chapman H, Kaplan I, Mohn KGI, Langeland N, Cox RJ. Durable immune responses after BNT162b2 vaccination in home-dwelling old adults. Vaccine X. 2023 Apr;13:100262. doi: 10.1016/j.jvacx.2023.100262. Epub 2023 Jan 10. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |