Patient Selection and Study Design
This was a patient-blinded, superiority, randomized controlled trial, conducted at the Miami Transplant Institute, Jackson Health System, Miami, Florida, USA. The Miami Transplant Institute is one of the biggest SOT centers in North America, providing comprehensive care to all SOT recipients.We included SOT recipients with a functional graft, whose age was 18 years and older at the time of enrollment. Inclusion for enrollment consisted of recipients with a minimum of 1 month post-transplant and having received two doses of BNT162b2 vaccine. Of note, the prior vaccines could have been administered any time pre or post transplantation. The third dose should have been given at least 28 days from the second dose of BNT162b2 vaccination and at least 1-month post-transplant. Exclusion criteria included any significant side effects due to previous SARS-CoV-2 vaccination, people unable to consent, receipt of more than or equal to three doses of SARS-CoV-2 vaccination, pregnancy and patients who previously received monoclonal antibody treatment that are specifically directed against the spike protein for SARS-CoV-2 such as Bamlanivimab plus Etesevimab, Casirivimab plus Imdevimab, and Sotrovimab at any time prior to the trial. Of note, at the time of enrollment, Ticagevimab/Cilgavimab was not available in USA.This study was approved by local research ethics board and was given NCT05047640.