Phase IIb trial of in vivo electroporation mediated dual-plasmid hepatitis B virus DNA vaccine in chronic hepatitis B patients under lamivudine therapy

Table 3 Virological responses after the end of treatment with DNA vaccination or placebo injection in contrast to the baseline at week 12 in different analysis populations

Population	Response	12 wk after EOT (week 48)			28 wk after EOT (week 64)			36 wk after EOT (week 72)
		Vacc.	Ctr.	P value	Vacc.	Ctr.	P value	Vacc.	Ctr.	P value
mITT	No. of patients	107	115		107	115		107	115
	HBV DNA (log10 IU/mL), median (IQR)	3.06 (0-4.63)	3.05 (1.43-5.02)	0.742	2.18 (0-5.01)	2.78 (1.41-4.86)	0.164	1.88 (0-4.36)	2.37 (0-5.38)	0.329
	HBV DNA > 2 log10 IU/mL decrease, n (%)	11 (10.3)	4 (3.48)	0.044	13 (12.2)	6 (5.2)	0.065	10 (9.4)	7 (6.1)	0.362
	HBV DNA undetectable, n (%)	27 (25.2)	23 (20.0)	0.351	30 (28.0)	20 (17.4)	0.058	24 (22.4)	26 (22.6)	0.975
	HBeAg > 1 log10 IU/mL decrease, n (%)	22 (20.6)	22 (19.1)	0.789	ND	ND		37 (34.6)	27 (23.5)	0.068
	HBeAg seroconversion, n (%)	16 (15.0)	10 (8.7)	0.147	ND	ND		18 (16.8)	15 (13.0)	0.429
dPPS	No. of patients	98	108		75	87		68	81
	HBV DNA (log10 IU/mL), median (IQR)	2.99 (0-4.59)	3.05 (1.43-5.02)	0.593	2.16 (0-4.66)	2.78 (1.41-4.86)	0.104	1.85 (0-3.78)	2.37 (0-5.38)	0.262
	HBV DNA > 2 log10 IU/mL decrease, n (%)	11 (11.2)	4 (3.8)	0.038	13 (17.3)	6 (7.1)	0.040	10 (14.7)	7 (8.9)	0.246
	HBV DNA undetectable, n (%)	27 (27.6)	23 (21.3)	0.296	29 (38.7)	20 (23.0)	0.030	24 (35.3)	26 (32.1)	0.681
	HBeAg > 1 log10 IU/mL decrease, n (%)	20 (20.4)	21 (19.4)	0.863	ND	ND		29 (42.7)	25 (30.9)	0.136
	HBeAg seroconversion, n (%)	16 (16.3)	10 (9.3)	0.127	ND	ND		18 (26.5)	15 (18.5)	0.244
Subgroup1	No. of patients	11	19		11	19		11	19
	HBV DNA (log10 IU/mL), median (IQR)	0 (0-1.16)	1.43 (0-2.64)	0.268	0 (0-0)	1.73 (0-3.6)	0.053	0 (0-0)	0 (0-4.32)	0.172
	HBV DNA undetectable, n (%)	8 (72.7)	7 (36.8)	0.128	8 (72.7)	8 (44.1)	0.142	7 (63.6)	9 (47.4)	0.466
	HBeAg seroconversion, n (%)	5 (45.5)	2 (10.5)	0.068	ND	ND		6 (54.6)	3 (15.8)	0.042
dPPS of subgroup2	No. of patients	11	19		9	18		9	17
	HBV DNA (log10 IU/mL), median (IQR)	0 (0-1.16)	1.43 (0-2.64)	0.268	0 (0-0)	1.73 (0-3.6)	0.053	0 (0-0)	0 (0-4.32)	0.172
	HBV DNA undetectable, n (%)	8 (72.7)	7 (36.8)	0.128	8 (88.9)	8 (44.4)	0.042	7 (77.8)	9 (52.9)	0.399
	HBeAg seroconversion, n (%)	5 (45.5)	2 (10.5)	0.068	ND	ND		6 (66.7)	3 (17.7)	0.028

¹Subgroup, 30 patients with HBV DNA < 1000 copies/mL (1.79 × 10² IU/mL) at week 12;

²dPPS of subgroup, population for analysist of the 30 patients with HBV DNA < 1000 copies/mL (1.79 × 10² IU/mL) at week 12 by ruling out the ADV add-on cases at each time point instantly after ADV administration due to lamivudine (LAM) antiviral failure. Data were analyzed with Fisher’s exact test. mITT: Modified intent to treat; dPPS: Dynamic per-protocol set by ruling out the adefovir (ADV) add-on cases at each time point instantly after ADV administration due to lamivudine (LAM) antiviral failure; ND: Not detected; Vacc.: LAM + DNA vaccine arm; Ctr.: LAM + placebo arm.