HCV-specific immune responses induced by CIGB-230 in combination with IFN-α plus ribavirin

Table 3 Cell-mediated immune responses

Antigen		Control group			E6 group			E9 group			L6 group			L9 group
		Week 0	Week 48	P value	Week 0	Week 48	P value	Week 0	Week 48	P value	Week 0	Week 48	P value	Week 0	Week 48	P value
Lymphoproliferative response
Capsid	Total n	25	25		14	13		15	14		13	14		12	11
	Positive (%)	4	0	ns	7.1	15.4	ns	20	14.3	ns	38.5	7.1	ns	8.3	18.2	ns
	SI1	1.2 ± 0.8	0.8 ± 0.5	ns	1.1 ± 0.6	1.2 ± 0.9	ns	1.8 ± 1.2	2.5 ± 3.4	ns	2.3 ± 2.0	1.5 ± 1.2	ns	1.5 ± 0.8	1.7 ± 1.8	ns
E2	Total n	25	23		13	9		14	10		13	10		12	9
	Positive (%)	16	8.7	ns	7.7	11.1	ns	21.4	0	ns	23.1	0	ns	13.3	0	ns
	SI	1.5 ± 1.8	1.6 ± 3.1	ns	0.9 ± 0.7	1.2 ± 1.2	ns	2.2 ± 2.2	0.6 ± 0.3	0.04	2.3 ± 2.4	1.1 ± 0.6	ns	1.4 ± 1.1	1.2 ± 0.8	ns
NS3	Total n	24	21		13	9		13	10		13	10		12	8
	Positive (%)	8.3	0	ns	7.7	11.1	ns	7.7	0	ns	30.8	0	ns	8.3	0	ns
	SI	1.2 ± 0.9	1.0 ± 0.6	ns	1.2 ± 0.8	2.0 ± 3.5	ns	1.7 ± 1.4	1.1 ± 0.4	ns	2.0 ± 1.3	0.9 ± 0.4	0.03	1.3 ± 0.8	1.1 ± 0.5	ns
IFN-γ ELISPOT response
Capsid	Total n	24	22		13	9		11	7		12	9		9	7
	Positive (%)	16.7	9.1	ns	23.1	0	ns	27.3	12.5	ns	8.3	27.3	ns	33.3	0	-
	SFC	151.4 ± 228.4	38.2 ± 67.3	0.003	232.9 ± 466.2	49.8 ± 94.1	ns	422.4 ± 731.7	50.5 ± 80.1	ns	120.9 ± 112.4	101.0 ± 89.5	ns	330.0 ± 214.7	116.0 ± 125.3	ns
E2	Total n	15	16		10	7		5	4		6	4		2	4
	Positive (%)	20	12.5	ns	10	0	-	0	0	-	0	20	ns	50	0	-
	SFC	84.6 ± 117.9	42.0 ± 82.4	0.040	96.8 ± 144.1	31.2 ± 54.8	ns	245.7 ± 409.4	3.9 ± 1.7	ns	19.9 ± 14.4	30.0 ± 33.6	ns	120.6 ± 73.9	23.3 ± 24.8	ns
NS3	Total n	17	12		9	4		1	4		7	3		4	3
	Positive (%)	15.4	8.3	ns	11.1	0	-	100	0	ns	100	0	-	25	0	-
	SFC	132.1 ± 259.7	52.0 ± 97.4	0.030	329.1 ± 452.3	2.5 ± 3.5	ns	110.8 ± 0.0	7.92 ± 10.7	-	31.3 ± 30.8	26.9 ± 23.5	ns	260.7 ± 315.7	15.2 ± 8.4	ns

Data on number of positive samples are presented as percent of total evaluated samples. Stimulation index and spot forming cells data are presented as mean ± SD. Statistical values refer to time dependent differences in one group (week 0 vs week 48; P < 0.05, Wilcoxon signed rank test).

¹A statistically significant difference regarding core-specific lymphoproliferation was observed among the groups on week 0 (P = 0.04, Kruskal-Wallis test), but the multiple comparison test was not potent enough to indicate which of the groups accounted for the difference. SI: Stimulation index; ns: Not significant; SFC: Sport forming cells/10⁶ cells.