Outcomes
diarrhea, fatigue, nausea and vomiting, erythema, pain, muscle pain, headache, tenderness, anaphylactic reactions
ADVERSE EVENT, VIRUS, ANAPHYLACTIC REACTION, ADVERSE EVENTS, ERYTHEMA, SECONDARY, HAND SWELLING, ADVERSE REACTION
Our primary safety outcomes were immediate anaphylactic reactions following vaccination and local and systemic adverse events during the week after receiving each vaccine/placebo dose. Participants were kept under close observation in the trial unit for 3 h following vaccination and their vital signs were monitored hourly. Participants were provided with a mobile application to record their daily pre-specified local (pain, tenderness or pain when the injection site is touched, erythema, and swelling or stiffness) and systemic (nausea and vomiting, diarrhea, headache, fatigue, and muscle pain) adverse events up to a week and received daily text reminders to do so. Those who did not complete the relevant forms on the application were contacted and the information was collected by telephone. (see Additional file Our primary and secondary immunogenicity outcomes were serum ELIZA IgG level for SARS-CoV-2 S1-RBD antigen and serum neutralizing activity measured by conventional virus neutralization test two and four weeks after the second injection, respectively. The measurements were repeated three and six months after the first vaccination. Serum lymphokines, including IL6 and other immunologic indices, were assessed in the peripheral blood before and after vaccine/placebo injections. Secondary safety outcomes included laboratory evaluations 1 week after the first (all participants) and second (above 55 year-olds only) injections. Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reaction (SUSARs) and, Medically Attended Adverse Events (MAAEs) were also monitored for up to 6 months [for further details see Additional file 