Infant immune response to hepatitis B vaccine after fetal exposure to telbivudine

Figures & data

Figure 1. Enrollment and follow-up of the subjects.

Table 1. Baseline characteristics of participants before and after PSM

Variable	Before PSM				After PSM
n (%)/Mean ± SD	LdT (n = 42)	Control (n = 348)	P	SMD	LdT (n = 42)	Control (n = 126)	P	SMD
Mothers
Gestational
Age(week)	39.14 ± 1.20	39.05 ± 1.12	.610	0.078	39.14 ± 1.20	39.12 ± 1.02	.900	0.020
Mode of delivery
Vaginal	12(28.57)	167(47.99)			12(28.57)	40(31.75)
Cesarean section	30(71.43)	181(52.01)	.017	0.425	30(71.43)	86(68.25)	.847	0.069
HBsAg (10^3S/CO)	1.78 ± 1.39	3.27 ± 2.48	<.001	−1.079	1.78 ± 1.39	1.73 ± 1.76	.884	0.032
HBeAg (10^2S/CO)	8.93 ± 5.19	3.99 ± 5.69	<.001	0.951	8.93 ± 5.19	8.52 ± 5.96	.689	0.079
HBVDNA (10^7IU/ml)	7.14 ± 1.74	5.46 ± 1.50	.503	0.096	7.14 ± 1.74	8.78 ± 1.60	.574	−0.094
Neonates
Gender
Male	23(54.76)	157(45.11)			23(54.76)	62(52.38)
Female	19(45.24)	191(54.89)	.236	−0.194	19 (45.24)	60 (47.62)	.929	−0.048
Weight(kg)	3.46 ± 0.42	3.38 ± 0.43	.235	0.195	3.46 ± 0.42	3.43 ± 0.43	.681	0.074

Abbreviations: PSM, Propensity score matching; SMD, Standardized mean difference.

Table 2. Quantitative comparison of infant immune outcomes between LdT and control group after PSM

Outcomes, M(IQR)	LdT group	Control group	z	P
Infant with anti-HBs, n	34	93
Anti-HBs GMC (mIU/mL)	767.70(745.35)	711.90(819.60)	−0.526	.599
Positive rate of anti-HBs	97.1%(33/34)	97.8%(91/93)	-	.999^a
Strong positive rate of anti-HBs	40.9%(38/93)	44.1%(15/34)	0.109	.742^b
Infant with immune cells(%), n ^c	29	68
Th	48.05(15.81)	45.64(17.73)	−1.076	.282
Tc	17.44(8.33)	14.96(6.45)	−0.595	.552
B cells	16.57(12.08)	17.41(8.04)	−0.044	.965
mDC	0.91(1.66)	0.94(0.92)	−0.093	.926
pDC	0.88(1.03)	0.67(0.95)	−0.882	.378
Infant with cytokines(pg/ml), n^d	33	85
IL-2	15.74(6.34)	15.74(8.95)	−0.529	.597
IL-4	11.18(4.55)	11.18(11.69)	−0.070	.944
IL-6	28.57(230.73)	32.00(323.93)	−1.398	.162
IL-10	0.79(1.85)	0.99(1.86)	−0.315	.753
IL-12	0.92(0.39)	0.92(0.45)	−0.315	.752
IFN-α	0.68(0.77)	0.65(0.49)	−0.093	.926
IFN-γ	0.82(1.53)	0.74(1.07)	−0.063	.950
TNF-α	3.21(6.88)	2.70(14.83)	−1.135	.256
Th1/Th2^e	0.438(0.837)	0.275(0.697)	−1.328	.184

^aFisher’s Exact Test.

^bPearson Chi-Square.

^c30 infants didn’t have enough blood samples to test immune cells.

^dNine infants didn’t have enough blood samples to test cytokines.

^eTh1/Th2 = (IL-2+IFN-γ+TNF-ɑ)/(IL-4+IL-6+IL-10).

Abbreviation: Th, Helper T cells; Tc, Cytotoxic T cells; mDC, myeloid dendritic cells; pDC, plasmacytoid dendritic cells.

Figure 2. The distribution of infants with negative, low, medium and high level of anti-HBs between LdT and control group after PSM. The proportion of infants with negative level, low level, medium level and high level of anti-HBs is 2.94% (1/34), 5.88% (2/34), 47.06% (16/34) and 44.12% (15/34) in LdT group, respectively. The proportion of infants with negative level, low level, medium level and high level of anti-HBs is 2.15% (2/93), 16.13% (15/93), 40.86% (38/93) and 40.86% (38/93) in control group, respectively.