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Table 2 Reported local and systemic adverse events (AEs)

From: A phase I, open-label trial on the safety and immunogenicity of the adjuvanted tuberculosis subunit vaccine H1/IC31® in people living in a TB-endemic area

 

Group 1

Group 2

Group 3

Group 4

TST/QFT at inclusion

Neg/Neg

Neg/Neg

Pos/Neg

Pos/Pos

Vaccination

H1 only

H1/IC31®

H1/IC31®

H1/IC31®

Number of participants

12

12

3

12

 

na (%) total AEs

n (%) total AEs

n (%) total AEs

n (%) total AEs

Local AEs

 Any local AE

5 (42) 9

3 (25) 9

1 (33) 4

9 (75) 20

 Injection site pain

0 (0) 0

3 (25) 6

1 (33) 1

4 (33) 5

 Injection site swelling

1 (8) 1

2 (17) 2

1 (33) 1

1 (8) 1

 Injection site erythema

2 (17) 2

0 (0) 0

1 (33) 1

2 (17) 2

 Injection site Itching

3 (25) 3

0 (0) 0

1 (33) 1

0 (0) 0

 Injection site numbness

0 (0) 0

0 (0) 0

0 (0) 0

2 (17) 2

 Injection site stiffness

0 (0) 0

0 (0) 0

0 (0) 0

2 (17) 2

 Injection site rash

0 (0) 0

1 (8) 1

0 (0) 0

0 (0) 0

 Erythema at TST site

2 (17) 2

0 (0) 0

0 (0) 0

3 (25) 4

 Itching at TST site

1 (8) 1

0 (0) 0

0 (0) 0

3 (25) 4

Systemic AEs

 Any systemic AE

11 (92) 86

9 (75) 72

2 (67) 7

12 (100) 45

 Headache

3 (25) 5

7 (58) 15

1 (33) 1

7 (58) 9

 Sediment in urineb

5 (42) 5

3 (25) 5

1 (33) 2

5 (42) 6

 Fever

2 (17) 2

3 (25) 4

1 (33) 1

3 (25) 3

 Sweating

3 (25) 4

1 (8) 1

0 (0) 0

2 (17) 2

 Anorexia

2 (17) 2

1 (8) 1

1 (33) 1

1 (8) 2

 Weakness

1 (8) 1

2 (17) 2

0 (0) 0

2 (17) 2

 Other (96 different categories)

10 (83) 67

9 (75) 44

1 (33) 2

7 (58) 21

  1. an signifies the number of participants experiencing the adverse event (AE) described
  2. bSediment refers to red and white blood cells, casts, bacteria, crystals and epithelial cells
  3. QFT QuantiFERON-TB Gold-in-tube test, TST Tuberculin Skin Test