Safety
diarrhoea, fatigue, rhinorrhea, treatment-emergent adverse, rash, pain, muscle pain, 2.There, headache, Toxicity
ADVERSE EVENTS, EVENT, ADVERSE EVENT, INJECTION SITE REACTION, EVENTS, CHRONIC DISEASE
No serious adverse events, events leading to study discontinuation, events of special interest, new onset chronic disease, or potential immune-mediated medical conditions were reported.After the first dose, solicited systemic and local reactions were absent or mild in most participants. Two participants (14.3%) in Cohort 2 (40-μg dose) experienced severe solicited systemic reactions (muscle pain and joint pain) and 1 participant (6.7%) in Cohort 2 experienced a severe solicited local injection site reaction (pain) (Fig. Summary of solicited systemic and local reactions. The plot represents the percentage of participants in each vaccine group (Cohort 1, 2, 3, and placebo) with local (Panel A) adverse events and solicited systemic (Panel B) adverse events through the third day post each vaccination according to FDA’s Toxicity Grading Scale (Grade 1, mild; Grade 2, moderate; Grade 3, severe; and Grade 4, potentially life threatening). There were no Grade 4 events. Participants who reported 0 events make up the remainder of the 100% calculation (not displayed). Participants that did not show any systemic symptom after vaccination are represented in the last row of panel B.After the second dose, solicited systemic and local reactions were absent or mild in most participants. One participant (6.7%) in Cohort 3 (100-μg dose) experienced a severe solicited systemic reaction (fatigue) and 3 participants (20.0%) in Cohort 3 experienced severe solicited local reactions (redness).The incidence of solicited local and systemic reactions was highest at the 100-μg dose level, particularly after the second dose. Overall, the most commonly reported solicited local event was pain at the injection site and systemic adverse events were headache, fatigue, and muscle pain (Fig. The most frequently reported (> 5.0% across all cohorts) unsolicited treatment-emergent adverse events, defined as adverse events which occurred or worsened after the start of study vaccination, from day 1 to day 42, in the PTX-COVID19-B groups were injection site reaction (33.3% of participants in Cohort 3), diarrhoea (13.3% and 6.7% of participants in Cohorts 2 and 3, respectively), rhinorrhea (13.3% of participants in Cohort 1), and rash (13.3% of participants in Cohort 2). There were no reports of Grade 4 adverse event after any dose across groups. Most adverse events were mild in severity and unrelated to the study drug (except injection site reaction) (Fig. Four participants had medically attended adverse events, none of which were considered related to the study drug except severe injection site reactions in two participants in Cohort 2.There have been no cases of COVID-19 reported up to week 26.