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

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