Inadequate Antibody Response to mRNA SARS-CoV-2 Vaccination in Kidney Transplant Recipients

Researchers from Tel Aviv University have conducted a study on the inadequate antibody response to mRNA SARS-CoV-2 vaccination in kidney transplant recipients. The study, titled "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: Protocol for a Randomised Controlled Trial (Became Study)," aimed to investigate the efficacy of a third vaccine dose in reducing immunosuppression in these patients. The study found that immunosuppression level and the use of antimetabolite in the maintenance immunosuppressive regimen were associated with inadequate response.

Key Takeaways:

• The study found that immunosuppression level and the use of antimetabolite in the maintenance immunosuppressive regimen were associated with inadequate antibody response to mRNA SARS-CoV-2 vaccination in kidney transplant recipients.
• The researchers conducted a single-centre, open-label, investigator-initiated randomised controlled trial, comparing immunosuppression reduction combined with a third BNT162b2 vaccine dose versus third dose alone.
• 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.
• The study also planned to perform a prospective observational study, evaluating seropositivity among approximately 350 kidney transplant recipients who consented to receive a third vaccine dose.
• The trial was approved by the local ethics committee of Rabin Medical Center (RMC-0192-21), and all participants were required to provide written informed consent.

Statistics:

• 154 patients were planned to participate in the randomised controlled trial.
• The study assumed 25% seropositivity in the control group and 50% in the intervention group.
• Approximately 350 kidney transplant recipients were planned to participate in the prospective observational study.

Sources:

• 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: Protocol for a Randomised Controlled Trial (Became Study). BMJ Open, 2021;11(10). BMJ Publishing Group, British Med Assoc House, Tavistock Square, London WC1H 9JR, England.
• Medical Letter on the CDC & FDA. November 21, 2021; p 326.