COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05030974

J.S.F. Sanders

Not reported

2021-09-01

Completed

RCT

Randomized

Parallel

Open label

multi-center

Prevention

inclusion criteria: age 18 years or older received 2 doses of mrna-1273 (stratum b) according to the recommended vaccination schedule, with the last administration within the last nine months. for stratum a, also patients who received 2 doses of bnt162b2 and/or a third dose with a mrna vaccine (mrna-1273 or bnt162b2) within the last three months are eligible. at least 6 months after kidney transplantation negative seroresponse 14 to 56 days after vaccination, measured by a validated anti-spike igg assay of which the definition is dependent on the assay that is used. eligible for covid-19 vaccination as described by the instructions of the manufacturers of the vaccine (moderna and janssen) capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained) willing to adhere to the protocol and be available during the study period additional inclusion criteria to be eligible for stratum a: maintenance immunosuppressive therapy consisting of a calcineurin inhibitor (tacrolimus or cyclosporine), mmf/mpa, and prednisone in case of tacrolimus treatment: last tacrolimus pre-dose level while on current dosage above 4 μg/l in case of cyclosporine treatment: last cyclosporine pre-dose level while on current dosage above 75 μg/l prednisone dose at least 5 mg/day first or second transplantation calculated level of panel reactive antibodies prior to last transplantation below 85% no signs of acute rejection during the preceding year

multi-organ transplant recipient history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s). previous or active covid-19 disease active malignancy, except non-melanoma skin cancer inherited immune deficiency infection with human immunodeficiency virus (hiv) administration of t cell, b cell, or plasma cell depleting antibodies during the last 6 months any vaccination within a week before enrolment bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. additional exclusion criteria for stratum b: history of recurrent venous thrombosis or venous thrombosis <2 years before baseline immune-mediated diseases associated with thrombocytopenia such as itp and ahus

5

University Medical Center Groningen

18

100

Netherlands

High risk patients

N/A

336

Positive SARS-CoV-2 seroresponse

None

Phase 4

[{"arm_notes": "third dose", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Patients treated with triple immunosuppressive therapy;third dose", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "with temporary discontinuation of MMF/MPA;third dose", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "patients treated with any combination of immunosuppressive drugs;third dose", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "patients treated with any combination of immunosuppressive drugs, receiving a 3rd dose of mRNA-1273 (100 \u03bcg, i.m) in both upper arms", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]