Responses to COVID19 Vaccination in Patients With a Treatment History of Rituximab. (RituxiVac)
27. maj 2021 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Forventet)
425
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Daniel Sidler, MD PhD
- Telefonnummer: 0041316323144
- E-mail: daniel.sidler@insel.ch
Undersøgelse Kontakt Backup
- Navn: Matthias B. Moor, MD PhD
- Telefonnummer: 0041316323144
- E-mail: matthias.moor@insel.ch
Studiesteder
-
-
BE
-
Bern, BE, Schweiz, 3010
- Rekruttering
- University Hospital Bern Inselspital
-
Kontakt:
- Daniel Sidler, MD PhD
- Telefonnummer: 00316323144
- E-mail: daniel.sidler@insel.ch
-
Kontakt:
- Matthias B. Moor, MD PhD
- Telefonnummer: 0316323144
- E-mail: matthias.moor@insel.ch
-
Ledende efterforsker:
- Daniel Sidler, MD PhD
-
Underforsker:
- Matthias B Moor, MD PhD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Participating Centers / Participating Departments: all at Bern University Hospital Insel)
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Immunocompetent controls
Participants aged at least 18 years, no history of COVID19, no history of anti-CD20 treatment
|
Completion of COVID19 vaccination course at least 4 weeks ago.
|
|
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
|
Completion of COVID19 vaccination course at least 4 weeks ago.
Intravenous treatment history of anti-CD20 treatment since 01/01/2010
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Humoral immune response to SARS-CoV2 spike protein
Tidsramme: At least 4 weeks after completion of COVID19 vaccination
|
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)
|
At least 4 weeks after completion of COVID19 vaccination
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Correlation of IgG antibodies against SARS-CoV2 with age, history, co-medication and biomarkers of immunocompetence
Tidsramme: At least 4 weeks after completion of COVID19 vaccination
|
Multivariable regression models for IgG antibodies against SARS-CoV2 with age, history, co-medication and biomarkers of immunocompetence as confounding variables.
|
At least 4 weeks after completion of COVID19 vaccination
|
|
Correlation of IgG antibodies against SARS-CoV2 with time interval since last dose of rituximab
Tidsramme: At least 4 weeks after completion of COVID19 vaccination
|
At least 4 weeks after completion of COVID19 vaccination
|
|
|
Correlation of IgG antibodies against SARS-CoV2 with cumulative dose of rituximab received.
Tidsramme: At least 4 weeks after completion of COVID19 vaccination
|
At least 4 weeks after completion of COVID19 vaccination
|
|
|
T cell anti-SARS-CoV2 response after COVID19 vaccination
Tidsramme: At least 4 weeks after completion of COVID19 vaccination
|
At least 4 weeks after completion of COVID19 vaccination
|
|
|
Correlation between IgG antibodies against SARS-CoV2 and B-cell counts, T-cell counts and total immunoglobulin levels
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Daniel Sidler, MD PhD, University Hospital Bern, Department of Nephrology and Hypertension
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
26. april 2021
Primær færdiggørelse (Forventet)
30. august 2021
Studieafslutning (Forventet)
31. oktober 2021
Datoer for studieregistrering
Først indsendt
6. maj 2021
Først indsendt, der opfyldte QC-kriterier
6. maj 2021
Først opslået (Faktiske)
7. maj 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. juni 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. maj 2021
Sidst verificeret
1. maj 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 4749
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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