Table 2.
Summary of all TEAEs per treatment group and pooled UB-312 cohorts
| Treatment group | UB-312 | |||||||
|---|---|---|---|---|---|---|---|---|
| 300/100/100 μg | 300/300/300 μg | Pooled | Placebo | |||||
| Number of participants | 7 | 7 | 14 | 6 | ||||
| System organ class/preferred term | Events | Participants | Events | Participants | Events | Participants | Events | Participants |
| N | N (%) | N | N (%) | N | N (%) | N | N (%) | |
| Any events | 59 | 7 (100.0) | 42 | 7 (100.0) | 101 | 14 (100.0) | 20 | 5 (83.3) |
| Cardiac disorders: | 1 | 1 (14.3) | 2 | 1 (14.3) | 3 | 2 (14.3) | 2 | 1 (16.7) |
| Arrhythmia | – | – | – | – | – | – | 1 | 1 (16.7) |
| Atrial fibrillation | – | – | – | – | – | – | 1 | 1 (16.7) |
| Palpitations | 1 | 1 (14.3) | 2 | 1 (14.3) | 3 | 2 (14.3) | – | – |
| Eye disorders: | 1 | 1 (14.3) | – | – | 1 | 1 (7.1) | – | – |
| Vision blurred | 1 | 1 (14.3) | – | – | 1 | 1 (7.1) | – | – |
| Gastrointestinal disorders: | 2 | 2 (28.6) | 2 | 1 (14·3) | 4 | 3 (21·4) | 1 | 1 (16.7) |
| Diarrhea | 2 | 2 (28.6) | 1 | 1 (14.3) | 3 | 3 (21.4) | – | – |
| Nausea | – | – | 1 | 1 (14.3) | 1 | 1 (7.1) | 1 | 1 (16.7) |
| General disorders and administration site conditions: | 8 | 4 (57.1) | 4 | 2 (28.6) | 12 | 6 (42.9) | 5 | 3 (50.0) |
| Chest pain | 1 | 1 (14.3) | – | – | 1 | 1 (7.1) | – | – |
| Fatigue | 4 | 3 (42.9) | 1 | 1 (14.3) | 5 | 4 (28.6) | 2 | 1 (16.7) |
| Injection-site pain | 3 | 2 (28.6) | 1 | 1 (14.3) | 4 | 3 (21.4) | 3 | 2 (33.3) |
| Malaise | – | – | 2 | 1 (14.3) | 2 | 1 (7.1) | – | – |
| Infections and infestations: | 9 | 4 (57.1) | 10 | 5 (71.4) | 19 | 9 (64.3) | 1 | 1 (16.7) |
| Acute sinusitis | – | – | 1 | 1 (14.3) | 1 | 1 (7.1) | – | – |
| Coronavirus disease 2019 | 2 | 2 (28.6) | 2 | 2 (28.6) | 4 | 4 (28.6) | – | – |
| Gastroenteritis | – | – | 1 | 1 (14.3) | 1 | 1 (7.1) | – | – |
| Pharyngitis | – | – | 1 | 1 (14.3) | 1 | 1 (7.1) | – | – |
| Pneumonia | 1 | 1 (14.3) | – | – | 1 | 1 (7.1) | – | – |
| Post-acute coronavirus disease 2019 syndrome | 1 | 1 (14.3) | 1 | 1 (14.3) | 2 | 2 (14.3) | ||
| Respiratory tract infection | – | – | 1 | 1 (14.3) | 1 | 1 (7.1) | – | – |
| Rhinitis | – | – | 1 | 1 (14.3) | 1 | 1 (7.1) | – | – |
| Upper respiratory tract infection | 2 | 2 (28.6) | 1 | 1 (14.3) | 3 | 3 (21.4) | 1 | 1 (16.7) |
| Urinary tract infection | 1 | 1 (14.3) | 1 | 1 (14.3) | 2 | 2 (14.3) | – | – |
| Urosepsis | 1 | 1 (14.3) | – | – | 1 | 1 (7.1) | – | – |
| Viral infection | 1 | 1 (14.3) | – | – | 1 | 1 (7.1) | – | – |
| Injury, poisoning and procedural complications: | 8 | 6 (85.7) | 1 | 1 (14.3) | 9 | 7 (50) | 3 | 2 (33.3) |
| Clavicle fracture | 1 | 1 (14.3) | – | – | 1 | 1 (7.1) | – | – |
| Concussion | 1 | 1 (14.3) | – | – | 1 | 1 (7.1) | 1 | 1 (16.7) |
| Muscle strain | – | – | – | – | – | – | 1 | 1 (16.7) |
| Post-lumbar puncture syndrome | 1 | 1 (14.3) | – | – | 1 | 1 (7.1) | – | – |
| Local pain after lumbar puncture | 4 | 4 (57.1) | 1 | 1 (14.3) | 5 | 5 (35·7) | 1 | 1 (16.7) |
| Skin laceration | 1 | 1 (14.3) | – | – | 1 | 1 (7.1) | – | – |
| Investigations: | 1 | 1 (14.3) | – | – | 1 | 1 (7.1) | – | – |
| Blood pressure systolic increased | 1 | 1 (14.3) | – | – | 1 | 1 (7.1) | – | – |
| Metabolism and nutrition disorders: | – | – | 1 | 1 (14.3) | 1 | 1 (7.1) | – | – |
| Hypercholesterolemia | – | – | 1 | 1 (14.3) | 1 | 1 (7.1) | – | – |
| Musculoskeletal and connective tissue disorders: | 8 | 2 (28.6) | 2 | 2 (28.6) | 10 | 4 (28.6) | – | – |
| Myalgia | 7 | 2 (28.6) | 2 | 2 (28.6) | 9 | 4 (28.6) | – | – |
| Plantar fasciitis | 1 | 1 (14.3) | – | – | 1 | 1 (7.1) | – | – |
| Nervous system disorders: | 14 | 6 (85.7) | 13 | 7 (100.0) | 27 | 13 (92.9) | 4 | 4 (66.7) |
| Carpal tunnel syndrome | – | – | – | – | 1 | 1 (16.7) | ||
| Dizziness | 2 | 2 (28.6) | 1 | 1 (14.3) | 3 | 3 (21.4) | – | – |
| Headache | 10 | 5 (71.4) | 10 | 6 (85.7) | 20 | 11 (78.6) | 3 | 3 (50.0) |
| Presyncope | 1 | 1 (14.3) | 1 | 1 (14.3) | 2 | 2 (14.3) | – | – |
| Sedation | – | – | 1 | 1 (14.3) | 1 | 1 (7.1) | – | – |
| Somnolence | 1 | 1 (14.3) | – | – | 1 | 1 (7.1) | – | – |
| Psychiatric disorders: | 1 | 1 (14.3) | 2 | 2 (28.6) | 3 | 3 (21.4) | – | – |
| Insomnia | 1 | 1 (14.3) | 1 | 1 (14.3) | 2 | 2 (14.3) | – | – |
| Stress | – | – | 1 | 1 (14.·3) | 1 | 1 (7.1) | – | – |
| Renal and urinary disorders: | – | – | – | – | – | – | 1 | 1 (16.7) |
| Renal cyst | – | – | – | – | – | – | 1 | 1 (16.7) |
| Respiratory thoracic and mediastinal disorders: | 1 | 1 (14.3) | 2 | 2 (28.6) | 3 | 3 (21.4) | 1 | 1 (16.7) |
| Cough | – | – | 1 | 1 (14.3) | 1 | 1 (7.1) | – | – |
| Dyspnea | 1 | 1 (14.3) | – | – | 1 | 1 (7.1) | – | – |
| Epistaxis | – | – | – | – | 1 | 1 (16.7) | ||
| Sneezing | – | – | 1 | 1 (14.3) | 1 | 1 (7.1) | – | – |
| Skin and subcutaneous tissue disorders: | 2 | 1 (14.3) | – | – | 2 | 1 (7.1) | 1 | 1 (16.7) |
| Erythema | 1 | 1 (14.3) | – | – | 1 | 1 (7.1) | – | – |
| Photosensitivity reaction | – | – | – | – | – | – | 1 | 1 (16.7) |
| Rash | 1 | 1 (14.3) | – | – | 1 | 1 (7.1) | – | – |
| Vascular disorders: | 3 | 3 (42.9) | 3 | 3 (42.9) | 6 | 6 (42.9) | 1 | 1 (16.7) |
| Deep vein thrombosis | 1 | 1 (14.3) | – | – | 1 | 1 (7.1) | – | – |
| Orthostatic hypotension | – | – | 3 | 3 (42.9) | 3 | 3 (21.4) | 1 | 1 (16.7) |
| Peripheral venous disease | 2 | 2 (28.6) | – | – | 2 | 2 (14.3) | – | – |
Specific TEAEs are listed by total number of events (N), as well as number and percentage (N (%)) of participants reporting the specific adverse event. Headache, local pain after lumbar puncture and fatigue were the most frequently reported TEAEs after vaccination with UB-312. TEAEs appeared to occur equally after administration of UB-312 (14 of 14 participants) and placebo (5 of 6 participants).