Responses to COVID19 Vaccination in Patients With a Treatment History of Rituximab. (RituxiVac)
27 maj 2021 uppdaterad av: University Hospital Inselspital, Berne
Registry Study for COVID19 Vaccination Efficacy in Patients With a Treatment History of Rituximab.
Patients with treatment history of rituximab since 01.01.2019 and immunocompetent volunteers will be contacted to give a blood sample after their COVID19 vaccination, and in a subset also before vaccination.
Immune responses of antibodies and SARS-CoV2-specific T-cells to the vaccination will be quantified and the rituximab effect on COVID19 vaccine-induced immune responses is analyzed.
Studieöversikt
Status
Rekrytering
Betingelser
Studietyp
Observationell
Inskrivning (Förväntat)
425
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Daniel Sidler, MD PhD
- Telefonnummer: 0041316323144
- E-post: daniel.sidler@insel.ch
Studera Kontakt Backup
- Namn: Matthias B. Moor, MD PhD
- Telefonnummer: 0041316323144
- E-post: matthias.moor@insel.ch
Studieorter
-
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BE
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Bern, BE, Schweiz, 3010
- Rekrytering
- University Hospital Bern Inselspital
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Kontakt:
- Daniel Sidler, MD PhD
- Telefonnummer: 00316323144
- E-post: daniel.sidler@insel.ch
-
Kontakt:
- Matthias B. Moor, MD PhD
- Telefonnummer: 0316323144
- E-post: matthias.moor@insel.ch
-
Huvudutredare:
- Daniel Sidler, MD PhD
-
Underutredare:
- Matthias B Moor, MD PhD
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Participating Centers / Participating Departments: all at Bern University Hospital Insel)
Beskrivning
Inclusion Criteria:
- Patients who were treated with anti-CD20 treatment since 01.01.2010
- Patients who received a COVID19 vaccination (completion of all required doses) until target date (initial target: 30.05.21, but can be delayed to 30.06.21, 30.07.21 or 30.08.21 in case of insufficient enrollment)
- Volunteers without a history of anti-CD20 treatment exposure
- All: written informed consent.
Exclusion Criteria:
Exclusion criteria for patients (any of the following)
- Patients aged 18 years and younger at time of study enrollment and/or
- Pregnant or lactating women at time of study enrollment and/or
- Patients who do not provide written informed consent and/or
- Patients who have previously had a COVID19 infection (self-reported COVID19 disease, positive PCR or serology)
- Patients who are in a dependency relationship with the study personnel (hierarchical, social)
Exclusion criteria for volunteers (any of the following)
- Volunteers aged 18 years and younger at time of study enrollment and/or
- Pregnant or lactating women at time of study enrollment and/or
- Volunteers who do not provide informed consent and/or
- Volunteers who suffer from an active autoimmune disease, active cancer, immunosuppressive therapy, history of anti-CD20 treatment and/or
- Volunteers who have previously had a COVID19 infection (self-reported COVID19 disease, positive PCR or serology)
- Volunteers who did not complete their COVID19 vaccination
- Volunteers who are in a dependency relationship with the study personnel (hierarchical, social)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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Immunocompetent controls
Participants aged at least 18 years, no history of COVID19, no history of anti-CD20 treatment
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Completion of COVID19 vaccination course at least 4 weeks ago.
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Patients with a treatment history of rituximab
Participants aged at least 18 years, no history of COVID19, history of at least 1 dose of anti-CD20 treatment received since 01/01/2010
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Completion of COVID19 vaccination course at least 4 weeks ago.
Intravenous treatment history of anti-CD20 treatment since 01/01/2010
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Humoral immune response to SARS-CoV2 spike protein
Tidsram: At least 4 weeks after completion of COVID19 vaccination
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Percentage of all patients developing IgG antibodies against SARS-CoV2 spike protein that is comparable to the immunological response in immunocompetent controls (-2 standard deviations of mean)
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At least 4 weeks after completion of COVID19 vaccination
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Correlation of IgG antibodies against SARS-CoV2 with age, history, co-medication and biomarkers of immunocompetence
Tidsram: At least 4 weeks after completion of COVID19 vaccination
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Multivariable regression models for IgG antibodies against SARS-CoV2 with age, history, co-medication and biomarkers of immunocompetence as confounding variables.
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At least 4 weeks after completion of COVID19 vaccination
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Correlation of IgG antibodies against SARS-CoV2 with time interval since last dose of rituximab
Tidsram: At least 4 weeks after completion of COVID19 vaccination
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At least 4 weeks after completion of COVID19 vaccination
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|
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Correlation of IgG antibodies against SARS-CoV2 with cumulative dose of rituximab received.
Tidsram: At least 4 weeks after completion of COVID19 vaccination
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At least 4 weeks after completion of COVID19 vaccination
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T cell anti-SARS-CoV2 response after COVID19 vaccination
Tidsram: At least 4 weeks after completion of COVID19 vaccination
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At least 4 weeks after completion of COVID19 vaccination
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Correlation between IgG antibodies against SARS-CoV2 and B-cell counts, T-cell counts and total immunoglobulin levels
Tidsram: At least 4 weeks after completion of COVID19 vaccination
|
Multivariable regression models for IgG antibodies against SARS-CoV2 with B-cell counts, T-cell counts and total immunoglobulin levels as confounders.
|
At least 4 weeks after completion of COVID19 vaccination
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Daniel Sidler, MD PhD, University Hospital Bern, Department of Nephrology and Hypertension
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Sidler D, Born A, Schietzel S, Horn MP, Aeberli D, Amsler J, Moller B, Njue LM, Medri C, Angelillo-Scherrer A, Borradori L, Seyed Jafari SM, Radonjic-Hoesli S, Chan A, Hoepner R, Bacher U, Mani LY, Iype JM, Suter-Riniker F, Staehelin C, Nagler M, Hirzel C, Maurer B, Moor MB. Trajectories of humoral and cellular immunity and responses to a third dose of mRNA vaccines against SARS-CoV-2 in patients with a history of anti-CD20 therapy. RMD Open. 2022 Mar;8(1):e002166. doi: 10.1136/rmdopen-2021-002166.
- Moor MB, Suter-Riniker F, Horn MP, Aeberli D, Amsler J, Moller B, Njue LM, Medri C, Angelillo-Scherrer A, Borradori L, Radonjic-Hoesli S, Seyed Jafari SM, Chan A, Hoepner R, Bacher VU, Mani LY, Iype JM, Hirzel C, Maurer B, Sidler D. Humoral and cellular responses to mRNA vaccines against SARS-CoV-2 in patients with a history of CD20 B-cell-depleting therapy (RituxiVac): an investigator-initiated, single-centre, open-label study. Lancet Rheumatol. 2021 Nov;3(11):e789-e797. doi: 10.1016/S2665-9913(21)00251-4. Epub 2021 Sep 7. Erratum In: Lancet Rheumatol. 2022 Mar;4(3):e174.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
26 april 2021
Primärt slutförande (Förväntat)
30 augusti 2021
Avslutad studie (Förväntat)
31 oktober 2021
Studieregistreringsdatum
Först inskickad
6 maj 2021
Först inskickad som uppfyllde QC-kriterierna
6 maj 2021
Första postat (Faktisk)
7 maj 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 juni 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 maj 2021
Senast verifierad
1 maj 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 4749
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