Table 3.
Adverse events by system organ class for participants starting at 3 μg or 30 μg of Nexvax2.
| Treatment |
Nexvax2 |
Nexvax2 |
Nexvax2 |
Nexvax2 |
Nexvax2 |
Placebo |
|---|---|---|---|---|---|---|
| Starting dose, μg |
30 |
30 |
3 |
3 |
3 |
|
| Maintenance dose, μg |
300 |
300 |
300 |
300 |
900 |
|
| Cohort | 1 | 2 | 1 | 2 | 3 | All |
| Participants, n | 2 | 4 | 5 | 6 | 10 | 9 |
| Any adverse events | 2 (100%) 34 | 4 (100%) 57 | 3 (60%) 16 | 6 (100%) 56 | 9 (90%) 44 | 9 (100%) 46 |
| Gastrointestinal disorders | 2 (100%) 11 | 4 (100%) 28 | 3 (60%) 5 | 6 (100%) 26 | 7 (70%) 13 | 6 (67%) 14 |
| Diarrhoea | 1 (50%) 1 | 2 (50%) 2 | 1 (20%) 1 | 5 (83%) 9 | 4 (40%) 5 | 1 (11%) 1 |
| Nausea | 2 (100%) 4 | 3 (75%) 10 | 1 (20%) 1 | 2 (33%) 3 | 2 (20%) 2 | 3 (33%) 4 |
| Abdominal pain | 1 (50%) 2 | 1 (25%) 1 | 0 (0%) 0 | 3 (50%) 6 | 2 (20%) 3 | 0 (0%) 0 |
| Abdominal pain upper | 1 (50%) 1 | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 |
| Abdominal pain lower | 0 (0%) 0 | 1 (25%) 1 | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 |
| Abdominal discomfort | 0 (0%) 0 | 2 (50%) 3 | 1 (20%) 1 | 2 (33%) 3 | 0 (0%) 0 | 2 (22%) 4 |
| Gastroesophageal reflux | 1 (50%) 2 | 1 (25%) 1 | 1 (20%) 1 | 0 (0%) 0 | 1 (10%) 1 | 0 (0%) 0 |
| Flatulence | 0 (0%) 0 | 1 (25%) 1 | 0 (0%) 0 | 0 (0%) 0 | 1 (10%) 1 | 1 (11%) 1 |
| Abdominal distension | 1 (50%) 1 | 1 (25%) 3 | 1 (20%) 1 | 1 (17%) 1 | 0 (0%) 0 | 2 (22%) 2 |
| Eructation | 0 (0%) 0 | 2 (50%) 5 | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 |
| Vomiting | 0 (0%) 0 | 1 (25%) 1 | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 1 (11%) 1 |
| Constipation | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 1 (11%) 1 |
| Nervous system disorders | 1 (50%) 3 | 4 (100%) 8 | 2 (40%) 3 | 4 (67%) 11 | 6 (60%) 9 | 3 (33%) 6 |
| Headache | 0 (0%) 0 | 2 (50%) 3 | 2 (40%) 2 | 4 (67%) 9 | 6 (60%) 8 | 1 (11%) 1 |
| Migraine | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 1 (17%) 1 | 0 (0%) 0 | 0 (0%) 0 |
| Tension headache | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 1 (10%) 1 | 0 (0%) 0 |
| Dizziness | 1 (50%) 2 | 1 (25%) 1 | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 1 (11%) 1 |
| Dysgeusia | 0 (0%) 0 | 2 (50%) 2 | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 |
| Lethargy | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 1 (17%) 1 | 0 (0%) 0 | 2 (22%) 2 |
| Syncope | 1 (50%) 1 | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 |
| General disorders & administration site conditions | 2 (100%) 13 | 3 (75%) 15 | 1 (20%) 4 | 3 (50%) 4 | 2 (20%) 4 | 3 (33%) 11 |
| Fatigue | 1 (50%) 2 | 2 (50%) 6 | 1 (20%) 1 | 1 (17%) 2 | 0 (0%) 0 | 2 (22%) 4 |
| Injection site reactions | 2 (100%) 6 | 2 (50%) 6 | 1 (20%) 1 | 2 (33%) 2 | 2 (20%) 2 | 2 (22%) 3 |
| Injection site erythema | 1 (50%) 4 | 2 (50%) 5 | 0 (0%) 0 | 0 (0%) 0 | 1 (10%) 1 | 2 (22%) 2 |
| Injection site pruritus | 1 (50%) 1 | 1 (25%) 1 | 0 (0%) 0 | 1 (17%) 1 | 0 (0%) 0 | 0 (0%) 0 |
| Injection site pain | 1 (50%) 1 | 0 (0%) 0 | 1 (20%) 1 | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 |
| Injection site reaction | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 1 (17%) 1 | 1 (10%) 1 | 0 (0%) 0 |
| Injection site bruise | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 1 (11%) 1 |
| Skin & subcutaneous tissue disorders | 2 (100%) 4 | 1 (25%) 1 | 0 (0%) 0 | 2 (33%) 3 | 4 (40%) 4 | 0 (0%) 0 |
| Ecchymosis | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 1 (17%) 2 | 1 (10%) 1 | 0 (0%) 0 |
| Infections and infestations | 1 (50%) 1 | 1 (25%) 1 | 1 (20%) 1 | 1 (17%) 1 | 4 (40%) 8 | 1 (11%) 1 |
| URTI | 0 (0%) 0 | 1 (25%) 1 | 0 (0%) 0 | 0 (0%) 0 | 2 (20%) 5 | 1 (11%) 1 |
| Musculoskeletal & connective tissue disorders | 1 (50%) 1 | 1 (25%) 2 | 0 (0%) 0 | 1 (17%) 1 | 3 (30%) 3 | 5 (56%) 8 |
| Arthralgia | 1 (50%) 1 | 1 (25%) 1 | 0 (0%) 0 | 1 (17%) 1 | 1 (10%) 1 | 1 (11%) 1 |
| Back pain | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 1 (10%) 1 | 2 (22%) 2 |
| Musculoskeletal pain | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 2 (22%) 3 |
| Injury, poisoning, & procedural complications | 0 (0%) 0 | 0 (0%) 0 | 1 (20%) 2 | 3 (50%) 3 | 0 (0%) 0 | 3 (33%) 4 |
| Contusion | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 1 (17%) 1 | 0 (0%) 0 | 2 (22%) 2 |
| Vascular disorders | 0 (0%) 0 | 1 (25%) 1 | 0 (0%) 0 | 2 (33%) 2 | 1 (10%) 1 | 0 (0%) 0 |
| Phlebitis | 0 (0%) 0 | 0 (0%) 0 | 0 (0%) 0 | 2 (33%) 2 | 0 (0%) 0 | 0 (0%) 0 |
Data are n (%) and total number adverse events. Treatment-emergent adverse events are shown only if reported by more than one participant.