Clinical trial NCT04877496: Responses to COVID19 Vaccination in Patients With a Treatment History of Rituximab.
Official title: Registry Study for COVID19 Vaccination Efficacy in Patients With a Treatment History of Rituximab.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID19 Vaccination
Rituximab
Immunosuppression
Keywords: B-cells
T-cells
COVID19 vaccine
SARS-CoV2
Rituximab
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 425
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participating Centers / Participating Departments: all at Bern University Hospital Insel)

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Patients who were treated with anti-CD20 treatment since 01.01.2010
2. 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)
3. Volunteers without a history of anti-CD20 treatment exposure
4. All: written informed consent.

Exclusion Criteria:

Exclusion criteria for patients (any of the following)

1. Patients aged 18 years and younger at time of study enrollment and/or
2. Pregnant or lactating women at time of study enrollment and/or
3. Patients who do not provide written informed consent and/or
4. Patients who have previously had a COVID19 infection (self-reported COVID19 disease, positive PCR or serology)
5. Patients who are in a dependency relationship with the study personnel (hierarchical, social)

Exclusion criteria for volunteers (any of the following)

1. Volunteers aged 18 years and younger at time of study enrollment and/or
2. Pregnant or lactating women at time of study enrollment and/or
3. Volunteers who do not provide informed consent and/or
4. Volunteers who suffer from an active autoimmune disease, active cancer, immunosuppressive therapy, history of anti-CD20 treatment and/or
5. Volunteers who have previously had a COVID19 infection (self-reported COVID19 disease, positive PCR or serology)
6. Volunteers who did not complete their COVID19 vaccination
7. Volunteers who are in a dependency relationship with the study personnel (hierarchical, social)

Primary outcomes:
measure: Humoral immune response to SARS-CoV2 spike protein
timeFrame: At least 4 weeks after completion of COVID19 vaccination
Secondary outcomes:
measure: Correlation of IgG antibodies against SARS-CoV2 with age, history, co-medication and biomarkers of immunocompetence
timeFrame: At least 4 weeks after completion of COVID19 vaccination
measure: Correlation of IgG antibodies against SARS-CoV2 with time interval since last dose of rituximab
timeFrame: At least 4 weeks after completion of COVID19 vaccination
measure: Correlation of IgG antibodies against SARS-CoV2 with cumulative dose of rituximab received.
timeFrame: At least 4 weeks after completion of COVID19 vaccination
measure: T cell anti-SARS-CoV2 response after COVID19 vaccination
timeFrame: At least 4 weeks after completion of COVID19 vaccination
measure: Correlation between IgG antibodies against SARS-CoV2 and B-cell counts, T-cell counts and total immunoglobulin levels
timeFrame: At least 4 weeks after completion of COVID19 vaccination
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital Bern Inselspital
state: BE
Study officials:
affiliation: University Hospital Bern, Department of Nephrology and Hypertension
name: Daniel Sidler, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.