TY - JOUR
T1 - Immunosuppression reduction when administering a booster dose of the BNT162b2 mRNA SARS-CoV-2 vaccine in kidney transplant recipients without adequate humoral response following two vaccine doses
T2 - Protocol for a randomised controlled trial (BECAME study)
AU - Yahav, Dafna
AU - Rozen-Zvi, Benaya
AU - Mashraki, Tiki
AU - Atamna, Alaa
AU - Ben-Zvi, Haim
AU - Bar-Haim, Erez
AU - Rahamimov, R.
N1 - Publisher Copyright:
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2021/10/11
Y1 - 2021/10/11
N2 - Introduction Inadequate antibody response to mRNA SARS-CoV-2 vaccination has been described among kidney transplant recipients. Immunosuppression level and specifically, use of antimetabolite in the maintenance immunosuppressive regimen, are associated with inadequate response. In light of the severe consequences of COVID-19 in solid organ transplant recipients, we believe it is justified to examine new vaccination strategies in these patients. Methods and analysis BECAME is a single-centre, open-label, investigator-initiated randomised controlled, superiority trial, aiming to compare immunosuppression reduction combined with a third BNT162b2 vaccine dose versus third dose alone. The primary outcome will be seropositivity rate against SARS-CoV-2. A sample size of 154 patients was calculated for the seropositivity endpoint assuming 25% seropositivity in the control group and 50% in the intervention group. A sample of participants per arm will be also tested for T-cell response. We also plan to perform a prospective observational study, evaluating seropositivity among ∼350 kidney transplant recipients consenting to receive a third vaccine dose, who are not eligible for the randomised controlled trial. Ethics and dissemination The trial is approved by local ethics committee of Rabin Medical Center (RMC-0192-21). All participants will be required to provide written informed consent. Results of this trial will be published; trial data will be available. Protocol amendments will be submitted to the local ethics committee. Trail registration number NCT04961229.
AB - Introduction Inadequate antibody response to mRNA SARS-CoV-2 vaccination has been described among kidney transplant recipients. Immunosuppression level and specifically, use of antimetabolite in the maintenance immunosuppressive regimen, are associated with inadequate response. In light of the severe consequences of COVID-19 in solid organ transplant recipients, we believe it is justified to examine new vaccination strategies in these patients. Methods and analysis BECAME is a single-centre, open-label, investigator-initiated randomised controlled, superiority trial, aiming to compare immunosuppression reduction combined with a third BNT162b2 vaccine dose versus third dose alone. The primary outcome will be seropositivity rate against SARS-CoV-2. A sample size of 154 patients was calculated for the seropositivity endpoint assuming 25% seropositivity in the control group and 50% in the intervention group. A sample of participants per arm will be also tested for T-cell response. We also plan to perform a prospective observational study, evaluating seropositivity among ∼350 kidney transplant recipients consenting to receive a third vaccine dose, who are not eligible for the randomised controlled trial. Ethics and dissemination The trial is approved by local ethics committee of Rabin Medical Center (RMC-0192-21). All participants will be required to provide written informed consent. Results of this trial will be published; trial data will be available. Protocol amendments will be submitted to the local ethics committee. Trail registration number NCT04961229.
KW - COVID-19
KW - immunology
KW - renal transplantation
UR - http://www.scopus.com/inward/record.url?scp=85117147251&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2021-055611
DO - 10.1136/bmjopen-2021-055611
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C2 - 34635537
AN - SCOPUS:85117147251
SN - 2044-6055
VL - 11
JO - BMJ Open
JF - BMJ Open
IS - 10
M1 - e055611
ER -