Table 2 Summary of all TEAEs per treatment group and pooled UB-312 cohorts

From: Target engagement and immunogenicity of an active immunotherapeutic targeting pathological α-synuclein: a phase 1 placebo-controlled trial

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)

–

–

  1. 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).
Back to article page