Outcome name:Collection of solicited local AEs (injection site pain; redness; swelling; and itching) and systemic AEs (fever; headache; fatigue; chills; myalgia; arthralgia; nausea/vomiting; and diarrhea) using diary cards (electronic or paper). In addition; other indicators of safety will be collected (e.g.; body temperature).Measure:Primary• The frequencies; intensities; and duration of solicited local AEs on each vaccination day and the following 7 days by dose and group.• The frequencies; intensities; duration; and relationship to trial vaccination of solicited systemic AEs on each vaccination day and the following 7 days by dose and group.• The occurrence; intensities and relationship to trial vaccination of unsolicited AEs on each vaccination day and the following 28 days by dose and group.• The occurrence and relationship to trial vaccination of SAEs and AESIs throughout the trial.On Day 29 and Day 43:• The proportion of subjects seroconverting for SARS-CoV-2 spike protein antibodies; as measured by enzyme-linked immunosorbent assay (ELISA).• Individual SARS-CoV-2 spike protein-specific antibody levels in serum; as measured by ELISA.• Geometric mean titers (GMTs) of serum SARS-CoV-2 spike protein antibodies; as measured by ELISA.• The proportion of subjects seroconverting for SARS-CoV-2 neutralizing antibodies; as measured by an activity assay.Individual SARS-CoV-2 neutralizing antibody levels in serum.• GMTs of serum SARS-CoV-2 neutralizing antibodies; as measured by an activity assayTimepoints:day 29 and day 43

Outcome name:Collection of solicited local AEs (injection site pain; redness; swelling; and itching) and systemic AEs (fever; headache; fatigue; chills; myalgia; arthralgia; nausea/vomiting; and diarrhea) using diary cards (electronic or paper). In addition; other indicators of safety will be collected (e.g.; body temperature).Measure:Primary• The frequencies; intensities; and duration of solicited local AEs on each vaccination day and the following 7 days by dose and group.• The frequencies; intensities; duration; and relationship to trial vaccination of solicited systemic AEs on each vaccination day and the following 7 days by dose and group.• The occurrence; intensities and relationship to trial vaccination of unsolicited AEs on each vaccination day and the following 28 days by dose and group.• The occurrence and relationship to trial vaccination of SAEs and AESIs throughout the trial.On Day 29 and Day 43:• The proportion of subjects seroconverting for SARS-CoV-2 spike protein antibodies; as measured by enzyme-linked immunosorbent assay (ELISA).• Individual SARS-CoV-2 spike protein-specific antibody levels in serum; as measured by ELISA.• Geometric mean titers (GMTs) of serum SARS-CoV-2 spike protein antibodies; as measured by ELISA.• The proportion of subjects seroconverting for SARS-CoV-2 neutralizing antibodies; as measured by an activity assay.Individual SARS-CoV-2 neutralizing antibody levels in serum.• GMTs of serum SARS-CoV-2 neutralizing antibodies; as measured by an activity assayTimepoints:day 29 and day 43