RECOVAC Repeated Vaccination Study
Covid19, Kidney Diseases, Vaccine Response Impaired
About this trial
This is an interventional prevention trial for Covid19
Eligibility Criteria
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
Exclusion Criteria:
- 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
Sites / Locations
- Radboud umc
- Amsterdam UMC
- Erasmus mc
- University Medical Center Groningen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
stratum A1 - one extra dose of mRNA-1273
stratum A2 - one extra dose of mRNA-1273 with discontinuation of MMF/MPA
stratum B1 - 3rd dose of mRNA-1273
statum B2 - 3rd double dose of mRNA-1273
stratum B3 - Ad26.COV2.S vaccine
Patients treated with triple immunosuppressive therapy consisting of a calcineurin inhibitor, MMF/MPA, and steroids, receiving a 3rd or 4th dose of mRNA-1273 (100 μg, i.m)
patients treated with triple immunosuppressive therapy consisting of a calcineurin inhibitor, MMF/MPA, and steroids, receiving a 3rd or 4th dose of mRNA-1273 (100 μg, i.m), with temporary discontinuation of MMF/MPA during one week before and one week after the extra dose
patients treated with any combination of immunosuppressive drugs, receiving a 3rd dose of mRNA-1273 (100 μg, i.m)
patients treated with any combination of immunosuppressive drugs, receiving a 3rd dose of mRNA-1273 (100 μg, i.m) in both upper arms
patients treated with any combination of immunosuppressive drugs, receiving a 3rd COVID vaccination with Ad26.COV2.S vaccine (Janssen, 5x1010 viral particles i.m.)