Table 2.

Numbers of subjects experiencing adverse events of grade 2 severity occurring from first day of study treatment to 28 days after the last study vaccination. Data are shown as number of subjects (percent). All events were included in the categories shown. Some subjects had more than one event. The highest severity of a given event for each subject was recorded

	Study group
	Placebo, n = 7 (Placebo × 3 or 6 doses)	Low-dose, n=6) (DermaVir, 0.1 mg × 3 doses)	Intermediate- dose, n=6 (DermaVir, 0.4 mg × 3 doses)	High-dose, n = 6 (DermaVir, 0.4 mg × 6 doses)	Overall	P- value
Any event	4 (57.1)	4 (66.7)	6 (100)	3 (50)	17 (68)	0.306†
General/systemic	1 (14.3)	2 (33.3)	2 (33.3)	2 (33.3)	7 (28)
Ache/pain/discomfort	0 (0)	1 (16.7)	1 (16.7)	2 (33.3)	4 (16)
Asthenia/fatigue/malaise	1 (14.3)	1 (16.7)	1 (16.7)	0 (0)	3 (12)
Fever	0 (0)	0 (0)	1 (16.7)	0 (0)	1 (4)
Skin abnormalities	2 (28.6)	3 (50)	0 (0)	0 (0)	5 (20)
Pruritus	1 (14.3)	2 (33.3)	0 (0)	0 (0)	3 (12)
Rash	1 (14.3)	1 (16.7)	0 (0)	0 (0)	2 (8)
Laboratory abnormalities*	2 (28.6)	2 (33.3)	4 (66.7)	2 (33.3)	10 (40)
Neurologic abnormalities**	1 (14.3)	1 (16.7)	1 (16.7)	1 (16.7)	4 (16)
Lymphadenopathy/edema	0 (0)	1 (16.7)	1 (16.7)	0 (0)	2 (8)

^*Events included hypoglycemia, hypo/hyperphosphatemia, increased creatinine, increased SGPT, and hyperbilirubinemia

^**Events included sleep disturbances, headache, and memory loss

^†Testing for a difference among all groups. Pairwise comparisons between groups were also not statistically significant