Safety
ADVERSE EVENT, ALLERGIC REACTIONS
AEs occurring up to 28 days post-vaccination in phase I and phase II clinical trial subjects have been previously reported where there were no acute allergic reactions, SAE, or AE of degree 3 or 4[8]. In phase, I, subjects who experienced AE degrees 1 and 2 to 28 days were 64.5%. Meanwhile, in phase II, which experienced AE degrees 1 and 2, it was 53.6%. The incidence of AE did not differ significantly between the three antigen dose groups, except that the proportion without AE was significantly higher in the 0.10 μg group when compared to the 1.00 μg group.Observations of the presence of AE occurred were made on all subjects of phase I and phase II clinical trials for up to 1 year. In addition to the incidence of COVID-19, 10 AEs that happened were not related to vaccine administration in phase I clinical trial subjects (Adverse event (AE) phase I clinical trials during a follow-up period of 1–12 months post-vaccination.AE phase II clinical trials during a follow-up period of 1–12 months post-vaccination.The meaning of bold values are the result from our study. 