Table 2.
Adverse events graded at least moderate severity in participants experiencing ≥1 gastrointestinal adverse graded at least moderate severity
| Treatment | Participant^ | Gluten challenge in screening |
Last dose number |
Onset after last dose |
Nausea | Abdominal Pain |
Vomiting | Diarrhea | Other |
|---|---|---|---|---|---|---|---|---|---|
| 3-dose study - weekly i.d. doses over 15 days | |||||||||
|
| |||||||||
| Nexvax2 60 µg | S03-01-07 | Yes | 1 | 2.0–2.5h | +++ | +++ | +++ | − | − |
| 2 | 3.5h | ++ | ++ | − | − | − | |||
| 3 | 3.5h | ++ | ++ | − | − | − | |||
|
| |||||||||
| Nexvax2 90 µg | S03-02-13 | Yes | 1 | 3h | +++ | ++ | +++ | − | − |
| 2 | 2h | − | − | + | − | − | |||
|
| |||||||||
| S03-02-08 | Yes | 1 | 0.5–2.75h | ++ | ++ | ++ | − | ||
| 2 | 2.5h | ++ | ++ | ++ | − | − | |||
| 3 | 2.5h | ++ | ++ | ++ | − | − | |||
|
| |||||||||
| S03-02-01 | Yes | 1 | 3.5h | ++ | − | ++ | − | − | |
| 2 | 2.75h | − | +++ | +++ | +++ | − | |||
| 3 | 2.25–3.25h | +++ | +++ | +++ | +++ | − | |||
|
| |||||||||
| S03-02-07 | Yes | 1 | 3–4h | ++ | ++ | ++ | ++ | +++1 | |
|
| |||||||||
| S03-02-10 | Yes | 1 | 3.25h | − | − | ++ | − | − | |
| 2 | 2.4h | − | − | ++ | − | − | |||
|
| |||||||||
| Nexvax2 150 µg | S03-03-03 | Yes | 1 | 4.3h | − | − | ++ | − | − |
| 2 | 3.2h | − | − | +++ | − | − | |||
|
| |||||||||
| S03-03-02 | Yes | 1 | 4h | − | − | ++ | − | − | |
|
| |||||||||
| S03-03-12 | Yes | 1 | 2.75–3.25h | ++ | − | ++ | − | − | |
| 3 | 3h | − | − | ++ | − | − | |||
|
| |||||||||
| S03-03-09 | Yes | 1 | 3h | − | − | ++ | − | − | |
|
| |||||||||
| Placebo | S03-03-05 | Yes | 1 | 0 | ++ | − | − | − | − |
| 2 | 24h | ++ | − | − | − | − | |||
|
| |||||||||
| S03-03-11 | Yes | 1 | 24h | − | − | − | − | +++2 | |
|
| |||||||||
| 16-dose study - twice weekly i.d. doses over 53 days | |||||||||
|
| |||||||||
| Nexvax2 150 µg | S16-01-03 | Yes | 1 | 2.75h | − | − | ++ | − | − |
|
| |||||||||
| S16-01-04 | Yes | 1 | 2.4h | − | − | ++ | − | − | |
|
| |||||||||
| S16-01-12 | Yes | 1 | 2.8–3.25h | +++ | +++3 | ||||
|
| |||||||||
| S16-01-06 | Yes | 1 | 3h | − | − | ++ | − | − | |
|
| |||||||||
| Nexvax2 300 µg | S16-02-07 | Yes | 1 | Same day | − | − | ++ | − | − |
|
| |||||||||
| S16-02-11 | Yes | 1 | 4.1h | − | − | ++ | − | − | |
|
| |||||||||
| S16-02-12 | Yes | 1 | 3.1h | − | − | ++ | − | − | |
|
| |||||||||
| S16-02-13 | Yes | 1 | 2.25h | − | ++++ | + | − | − | |
| 48h | − | +++ | ++ | − | − | ||||
|
| |||||||||
| Placebo | S16-02-04 | Yes | 14 | 24h | ++ | ||||
□
Participant code (SXX-YY-ZZ) refers to the planned total doses in the study, the cohort number (YY), and order of randomization within the cohort (ZZ)
Adverse event grading +: mild; ++: moderate; +++: severe; ++++: serious (grade 4)
1 Dizziness; Adverse drug reaction, 2 Viral upper respiratory tract infection, 3 rigors