Incidence and outcome of COVID-19 following vaccine and hybrid immunity in patients on immunosuppressive therapy : identification of protective post-immunisation anti-RBD antibody levels in a prospective cohort study
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ..
OBJECTIVES: To assess incidence, severity and predictors of COVID-19, including protective post-vaccination levels of antibodies to the receptor-binding domain of SARS-CoV-2 spike protein (anti-RBD), informing further vaccine strategies for patients with immune-mediated inflammatory diseases (IMIDs) on immunosuppressive medication.
METHODS: IMIDs on immunosuppressives and healthy controls (HC) receiving SARS-CoV-2 vaccines were included in this prospective observational study. COVID-19 and outcome were registered and anti-RBD antibodies measured 2-5 weeks post-immunisation.
RESULTS: Between 15 February 2021 and 15 February 2023, 1729 IMIDs and 350 HC provided blood samples and self-reported COVID-19. The incidence of COVID-19 was 66% in patients and 67% in HC, with re-infection occurring in 12% of patients. Severe COVID-19 was recorded in 22 (2%) patients and no HC. No COVID-19-related deaths occurred. Vaccine-induced immunity gave higher risk of COVID-19 (HR 5.89 (95% CI 4.45 to 7.80)) than hybrid immunity. Post-immunisation anti-RBD levels <6000 binding antibody units/mL were associated with an increased risk of COVID-19 following three (HR 1.37 (95% CI 1.08 to 1.74)) and four doses (HR 1.28 (95% CI 1.02 to 1.62)), and of COVID-19 re-infection (HR 4.47 (95% CI 1.87 to 10.67)).
CONCLUSION: Vaccinated patients with IMID have a low risk of severe COVID-19. Hybrid immunity lowers the risk of infection. High post-immunisation anti-RBD levels protect against COVID-19. These results suggest that knowledge on COVID-19 history, and assessment of antibody levels post-immunisation can help individualise vaccination programme series in high-risk individuals.
TRIAL REGISTRATION NUMBER: NCT04798625.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:10 |
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| Enthalten in: |
RMD open - 10(2024), 2 vom: 09. Apr. |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Ørbo, Hilde S [VerfasserIn] |
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| Links: |
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| Themen: |
Autoimmunity |
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| Anmerkungen: |
Date Completed 12.04.2024 Date Revised 25.04.2024 published: Electronic ClinicalTrials.gov: NCT04798625 Citation Status MEDLINE |
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| doi: |
10.1136/rmdopen-2023-003545 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM370889762 |
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| 100 | 1 | |a Ørbo, Hilde S |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Incidence and outcome of COVID-19 following vaccine and hybrid immunity in patients on immunosuppressive therapy |b identification of protective post-immunisation anti-RBD antibody levels in a prospective cohort study |
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| 500 | |a Date Completed 12.04.2024 | ||
| 500 | |a Date Revised 25.04.2024 | ||
| 500 | |a published: Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT04798625 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. | ||
| 520 | |a OBJECTIVES: To assess incidence, severity and predictors of COVID-19, including protective post-vaccination levels of antibodies to the receptor-binding domain of SARS-CoV-2 spike protein (anti-RBD), informing further vaccine strategies for patients with immune-mediated inflammatory diseases (IMIDs) on immunosuppressive medication | ||
| 520 | |a METHODS: IMIDs on immunosuppressives and healthy controls (HC) receiving SARS-CoV-2 vaccines were included in this prospective observational study. COVID-19 and outcome were registered and anti-RBD antibodies measured 2-5 weeks post-immunisation | ||
| 520 | |a RESULTS: Between 15 February 2021 and 15 February 2023, 1729 IMIDs and 350 HC provided blood samples and self-reported COVID-19. The incidence of COVID-19 was 66% in patients and 67% in HC, with re-infection occurring in 12% of patients. Severe COVID-19 was recorded in 22 (2%) patients and no HC. No COVID-19-related deaths occurred. Vaccine-induced immunity gave higher risk of COVID-19 (HR 5.89 (95% CI 4.45 to 7.80)) than hybrid immunity. Post-immunisation anti-RBD levels <6000 binding antibody units/mL were associated with an increased risk of COVID-19 following three (HR 1.37 (95% CI 1.08 to 1.74)) and four doses (HR 1.28 (95% CI 1.02 to 1.62)), and of COVID-19 re-infection (HR 4.47 (95% CI 1.87 to 10.67)) | ||
| 520 | |a CONCLUSION: Vaccinated patients with IMID have a low risk of severe COVID-19. Hybrid immunity lowers the risk of infection. High post-immunisation anti-RBD levels protect against COVID-19. These results suggest that knowledge on COVID-19 history, and assessment of antibody levels post-immunisation can help individualise vaccination programme series in high-risk individuals | ||
| 520 | |a TRIAL REGISTRATION NUMBER: NCT04798625 | ||
| 650 | 4 | |a Observational Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a autoimmunity | |
| 650 | 4 | |a biological therapy | |
| 650 | 4 | |a vaccination | |
| 650 | 7 | |a spike protein, SARS-CoV-2 |2 NLM | |
| 650 | 7 | |a COVID-19 Vaccines |2 NLM | |
| 650 | 7 | |a Vaccines |2 NLM | |
| 650 | 7 | |a Immunomodulating Agents |2 NLM | |
| 650 | 7 | |a Spike Glycoprotein, Coronavirus |2 NLM | |
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| 700 | 1 | |a Sexton, Joseph |e verfasserin |4 aut | |
| 700 | 1 | |a Jyssum, Ingrid |e verfasserin |4 aut | |
| 700 | 1 | |a Tveter, Anne T |e verfasserin |4 aut | |
| 700 | 1 | |a Christensen, Ingrid E |e verfasserin |4 aut | |
| 700 | 1 | |a Mjaaland, Siri |e verfasserin |4 aut | |
| 700 | 1 | |a Kvien, Tore K |e verfasserin |4 aut | |
| 700 | 1 | |a Grødeland, Gunnveig |e verfasserin |4 aut | |
| 700 | 1 | |a Kro, Grete B |e verfasserin |4 aut | |
| 700 | 1 | |a Jahnsen, Jørgen |e verfasserin |4 aut | |
| 700 | 1 | |a Haavardsholm, Espen A |e verfasserin |4 aut | |
| 700 | 1 | |a Munthe, Ludvig A |e verfasserin |4 aut | |
| 700 | 1 | |a Provan, Sella A |e verfasserin |4 aut | |
| 700 | 1 | |a Vaage, John T |e verfasserin |4 aut | |
| 700 | 1 | |a Goll, Guro Løvik |e verfasserin |4 aut | |
| 700 | 1 | |a Jørgensen, Kristin Kaasen |e verfasserin |4 aut | |
| 700 | 1 | |a Syversen, Silje Watterdal |e verfasserin |4 aut | |
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