Blinding, Unblinding, Randomization and Follow up
ADVERSE EVENTS, ADENOVIRUS
After obtaining written informed consent, adult SOT recipients were randomized in one to one ratio to receive either BNT162b2 vs. JNJ-78436735. BNT16b2 uses nucleoside-modified mRNA encoding the viral spike glycoprotein for SARS-CoV-2 as an ingredient. On the other hand, JNJ-78436735 uses recombinant, replication-incompetent Adenovirus 26 vector, encoding a stabilized variant of SARS-CoV-2 spike protein, as an ingredient. A randomization schedule was created electronically and simple randomization was performed. The participants’ blood specimens were collected to analyze anti-spike protein SARS-CoV-2 IgG. The patients were contacted by phone at day 3 and 7 post vaccination to monitor for adverse events. Follow-up blood test was planned between 21 and 35 days after the third dose of the vaccine to measure anti-spike protein SARS-CoV-2 IgG. We measured IgG titer to the SARS-CoV-2 spike protein receptor binding domain using enzyme-linked immunosorbent assay as described elsewhere (Of note, this study was not observer blinded. However, the laboratory members were not notified of the randomization results.