Laboratory safety tests
EVENTS, EVENT
Fluctuations in laboratory values, mostly considered not clinically significant, were noted across treatment arms and at various timepoints during the trial.Clinically significant abnormal values in Cohort 1 were: decreased in neutrophil count (3 events: BK-SE36/CpG, in two subjects (n = 2)), high serum creatinine (2 events: BK-SE36/CpG, n = 1; control, n = 1), high ALT (10 events: 9 from BK-SE36/CpG, n = 5; control, n = 1), high AST (9 events: 8 from BK-SE36/CpG, n = 4; control, n = 1), and high bilirubin (20 events: 9 from BK-SE36/CpG, n = 4; 11 from control, n = 3). Of 44 clinically significant fluctuations, one event (high serum creatinine in a BK-SE36/CpG subject) was possibly related to vaccination (Grade 1, resolved in 21 days) and reported as an unsolicited AE (as above). For Cohort 2 subjects, a decrease in haemoglobin (1 event: BK-SE36/CpG), high ALT (1 event: BK-SE36/CpG) and high AST (3 events: BK-SE36/CpG, n = 2; control, n = 1) were reported. For Cohort 3, decreased haemoglobin (1 event: BK-SE36/CpG), high ALT (4 events: BK-SE36/CpG, n = 3; control, n = 1) and high AST (5 events: 4 from BK-SE36/CpG, n = 3; control, n = 1) were reported. In Cohorts 2 and 3, none of the 5 and 10 clinically significant fluctuations, respectively, were related to vaccination.Changes in autoimmune markers (ANA, anti-dsDNA, p- and c-ANCA) were observed as transient fluctuations, high baseline/early elevations even for those who did not receive BK-SE36/CpG (Changes in laboratory autoimmune markers. Blue: BK-SE36 arm; pink: control arm. Day 0: prior to first Dose; Day 140: 4 weeks post Dose 3; Day 365: 1 year post Dose 1. Each row corresponds to a cohort indicated on the left. Results were interpreted according to CERBA Criteria: In all cohorts of both treatment arms, and at any visit some ANCA positive immunofluorescence were detected and as per SOP the specificity of the results were investigated by ANCA screen ELISA test intended for the detection of proteins in neutrophils: anti-myeloperoxidase (anti-MPO, perinuclear ANCA) and/or anti-proteinase 3 (anti-PR3, cytoplasmic ANCA). All testing for both p-ANCA and c-ANCA were negative. Furthermore, no subject was positive for at least two markers at the same scheduled visit and no positive events were associated with a particular clinical diagnosis.