Statistical Analysis and Sample Size Calculation
SARS-COV-2 INFECTION, SIDE EFFECT
The primary outcome of the study was anti-spike protein SARS-CoV-2 IgG positivity after 28 (21–35) days of the booster dose with either vaccine. Secondary outcomes included side effect, graft rejection, and SARS-CoV-2 infection. The follow-up period of the current study was 28 (21–35) days, up to the follow-up blood collection. We set alfa of 0.05 and beta of 0.2. For pre-specified outcome analysis, based on our hypothesis, we compared IgG positivity between two vaccines. As an ancillary analysis, we tried to identify the risk factors to develop or not to develop IgG positivity in this cohort. We assumed the anti-spike protein SARS-CoV-2 IgG positivity in JNJ-78436735 as 80% and BNT162b2 as 60% (Demographics were analyzed using descriptive statistics. Pre- and post-vaccination anti-spike protein SARS-CoV-2 IgG titers were compared using Wilcoxon rank-sum test. Univariate analyses were performed to determine significant factors affecting seroconversion using chi-squared or Fisher’s exact test for categorical variables and Mann–Whitney U for continuous variables. For multivariate analysis, we planned to construct a model using variables whose 