Statistical analysis
This Phase 1/2 clinical study was not designed to test any hypothesis. Thus, the sample size (n=50 for both groups) was calculated based on the probability of detecting frequent AEs (with a probability <10%) with a pre-determined sample size. The statistical analysis was performed using GraphPad Prism 9.3 and MS Excel 2019. When analyzing categorical data, we used Pearson’s Chi-square test. The Mann-Whitney test was used to compare the means of two unpaired samples. The Mann-Whitney U-test was used as a non-parametric alternative to Student’s t-test for small samples without a normal distribution. The non-parametric Wilcoxon test was used to compare the means of the two paired samples. The hypothesis testing was two-sided, with a p-value of less than 0.05 considered significant. We calculated two-sided 95% confidence intervals for the frequency of seroconversion using the Clopper-Pearson method. The correlation analysis was done with Spearman’s test, with the correlation coefficient 