Comparison of long-term immunogenicity (23 y) of 10 μg and 20 μg doses of hepatitis B vaccine in healthy children

Figures & data

Table 1. Anti-HBs seroprotection rates and GMTs for the original study sample and the current study sample at key time points, stratified by 10 μg and 20 μg vaccine dose groups

Time points after 1st dose	10 μg vaccine dose group				20 μg vaccine dose group
	No. tested (N)	n	Seroprotection rates^a with 95% C.I.	GMT with 95% C.I.	No. tested (N)	n	Seroprotection rates^a with 95% C.I.	GMT with 95% C.I.
Original study sample (n = 126)
7 mo^b	62	52	83.9 (74.2, 91.9)	35.1 (24.8, 50.6)	59	53	89.8 (81.4, 96.9)	44.4 (29.6, 58.7)
12 mo^b	61	51	83.6 (73.8, 91.8)	57.8 (37.6, 86.2)	58	54	93.1 (86.2, 98.3)	70.2 (49.9, 95.2)
36 mo^b	61	37	60.7 (45.9, 70.5)	12.7 (9.6, 21.4)	53	36	67.9 (54.7, 81.1)	11.9 (8.2, 16.7)
Year 6^b	58	35	60.3 (43.3, 69.5)	18.1 (10.1, 33.0)	55	35	63.6 (50.5, 78.1)	10.1 (5.6, 22.8)
Year 11^b	46	29	63.0 (47.9, 78.2)	13.5 (8.1, 20.3)	48	25	52.1 (37.5, 66.7)	8.7 (5.5, 12.4)
Year 23^c	35	21	60.0 (44.8, 76.5)	39.1 (16.6, 55.3)	46	27	58.7 (44.7, 72.9)	19.9 (9.7, 35.3)
Current study sample (n = 81)
7 mo^b	34	29	85.3 (71.6, 99.0)	39.8 (25.2, 63.0)	45	40	88.8 (79.1, 98.6)	40.5 (26.8, 60.4)
12 mo^b	33	26	77.5 (67.0, 90.5)	49.1 (32.7, 73.7)	44	42	95.4 (88.1, 99.0)	69.5 (44.3, 95.3)
36 mo^b	34	25	73.5 (61.7, 85.3)	15.7 (10.6, 28.6)	40	26	65.0 (57.5, 72.4)	11.7 (8.0, 16.9)
Year 6^b	33	25	75.8 (63.9, 87.5)	19.9 (11.6, 34.3)	42	33	78.0 (69.3, 87.7)	21.9 (14.3, 34.6)
Year 11^b	22	12	54.5 (38.8, 70.2)	14.5 (10.3, 21.2)	41	19	46.3 (32.0, 60.6)	9.8 (6.2, 15.5)
Year 23^c	35	21	60.0 (44.8 76.5)	39.1 (16.6, 55.3)	46	27	58.7 (44.7, 72.9)	19.9 (9.7, 35.3)

n = number of participants with seroprotective anti-HBs levels. ^a Anti-HBs titer ≥ 10 S/N ratio or ≥ 10 mIU/mL is defined as seroprotection. ^b Anti-HBs levels are expressed as S/N ratio. ^c Anti-HBs levels are expressed as mIU/mL, and subjects with a booster dose at Year 11 are included.

Table 2. Anti-HBs seroprotection rates and GMTs at Year 23 for10 μg and 20 μg vaccine dose group participants, stratified by participant characteristics at Year 11

Characteristics at Year 11	10 μg vaccine dose group				20 μg vaccine dose group
	No. tested (N)	n	Seroprotection rates^a	GMT with 95% C.I.	No. tested (N)	n	Seroprotection rates^a.	GMT with 95% C.I.
Anti-HBs S/N ratio ≥ 10	17	14	82.4	202.8 (135.1, 304.4)	19	16	84.2	94.3 (57.4, 154.9)
Anti-HBs S/N ratio < 10 and no booster dose	2	0	-	-	2	0	-	-
Anti-HBs S/N ratio < 10 and a booster dose	3	1	33.3	5.3 (0.8, 9.8)	20	8	40.0	6.0 (0.1, 12.1)
Anti-HBs levels at Year 11 missing	13	6	46.2	12.6(0.7, 23.6)	5	3	60.0	15.1 (5.1, 25.1)

n = number of participants with seroprotective anti-HBs levels. ^a Anti-HBs titer ≥ 10 mIU/mL is defined as seroprotection at Year 23.

Table 3. Factors independently associated with Year 23 seroprotection rates (anti-HBs > 10mIU/mL)

Factors	β coefficient	Odds Ratio	95% CI	P value
Anti-HBs level at 12 mo after 1st vaccine dose	1.453	4.28	(1.04, 17.56)	0.04
Anti-HBs level at Year 11	2.248	9.47	(2.34, 38.38)	0.01
Dosage of primary vaccination	0.049	1.05	(0.9, 1.23)	0.535
Sex	0.617	1.85	(0.48, 7.18)	0.373

Figure 1. Rise in anti-HBs titers before and after Year 23 booster dose in booster vaccine responsive participants.