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RECOVAC Repeated Vaccination Study
Bu çalışma, böbrek nakli olmuş ve önceki COVID-19 aşılarına yeterli antikor yanıtı vermemiş hastalarda tekrarlı aşılamanın (mRNA-1273 veya Ad26.COV2.S aşısı) etkisini incelemiştir. Çalışmaya, 18 yaş ve üzeri, nakilden en az 6 ay geçmiş ve aşıya zayıf yanıt vermiş hastalar alınmıştır. Faz 4 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: 1. Age 18 years or older 2. 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. 3. At least 6 months after kidney transplantation 4. 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. 5. Eligible for COVID-19 vaccination as described by the instructions of the manufacturers of the vaccine (Moderna and Janssen) 6. Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained) 7. Willing to adhere to the protocol and be available during the study period Additional inclusion criteria to be eligible for stratum A: 8. Maintenance immunosuppressive therapy consisting of a calcineurin inhibitor (tacrolimus or cyclosporine), MMF/MPA, and prednisone 9. In case of tacrolimus treatment: last tacrolimus pre-dose level while on current dosage above 4 μg/l 10. In case of cyclosporine treatment: last cyclosporine pre-dose level while on current dosage above 75 μg/l 11. Prednisone dose at least 5 mg/day 12. First or second transplantation 13. Calculated level of panel reactive antibodies prior to last transplantation below 85% 14. No signs of acute rejection during the preceding year Exclusion Criteria: 1. Multi-organ transplant recipient 2. 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). 3. Previous or active COVID-19 disease 4. Active malignancy, except non-melanoma skin cancer 5. Inherited immune deficiency 6. Infection with Human Immunodeficiency Virus (HIV) 7. Administration of T cell, B cell, or plasma cell depleting antibodies during the last 6 months 8. Any vaccination within a week before enrolment 9. 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: 10. History of recurrent venous thrombosis or venous thrombosis \<2 years before baseline 11. Immune-mediated diseases associated with thrombocytopenia such as ITP and aHUS