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Table 2 Frequency of AEs reported during the study (Intent-To-Treat Population).

From: IMP321 (sLAG-3), an immunopotentiator for T cell responses against a HBsAg antigen in healthy adults: a single blind randomised controlled phase I study

  Engerix®-B (N = 8) HBsAg alone (N = 8) HbsAg + IMP321 3μg (N = 9) HBsAg+ IMP321 10 μg (N = 9) HBsAg+ IMP321 30μg (N = 8) HBsAg+ IMP321 100μg (N = 8)
  n % AE n % AE n % AE n % AE n % AE n % AE
Total 5 62.5 5 2 25.0 4 5 55.6 8 2 22.2 4 2 25.0 3 4 50.0 11
Aphthous Stomatitis . . . . . . 1 11.1 1 . . . . . . . . .
Diarrhoea . . . . . . 1 11.1 1 . . . . . . . . .
Dyspepsia . . . . . . . . . . . . . . . 1 12.5 1
Nausea 1 12.5 1 . . . 1 11.1 1 . . . . . . . . .
Asthenia 2 25.0 2 . . . . . . . . . . . . 1 12.5 1
Influenza Like Illness . . . 1 12.5 1 . . . . . . . . . . . .
Injection Site Erythema . . . . . . . . . 1 11.1 1 1 12.5 1 . . .
Injection Site Haemorrhage . . . . . . 1 11.1 1 . . . 1 12.5 1 . . .
Injection Site Induration 1 12.5 1 . . . . . . . . . . . . . . .
Injection Site Pain 1 12.5 1 1 12.5 1 1 11.1 1 . . . . . . 1 12.5 1
Localised Oedema . . . . . . 1 11.1 1 . . . . . . . . .
Herpes Simplex . . . . . . 1 11.1 1 . . . . . . . . .
Sinusitis . . . 1 12.5 1 . . . . . . . . . . . .
Urinary Tract Infection . . . . . . 1 11.1 1 . . . . . . . . .
Contusion . . . . . . . . . . . . . . . 1 12.5 2
Back pain . . . . . . . . . . . . . . . 1 12.5 1
Myalgia . . . . . . . . . 1 11.1 1. . . . . . .
Headache . . . . . . . . . 2 22.2 2 . . . 2 25.0 3
Erythema . . . . . . . . . . . . 1 12.5 1 . . .
Pruritus . . . . . . . . . . . . . . . 1 12.5 1
Psoriasis . . . 1 12.5 1 . . . . . . . . . . . .
Rash Papular . . . . . . . . . . . . . . . 1 12.5 1
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