Table 2

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

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

Brignone et al. Journal of Immune Based Therapies and Vaccines 2007 5:5   doi:10.1186/1476-8518-5-5