Prospective clinical trial of hepatitis B vaccination for children with hematological malignancies: a study on the safety and immunogenicity efficacy

Figures & data

Figure 1. The procedure of participant recruitment and implementation.

Table 1. Analysis of general characteristics of subjects

Variable		Male	Female	t/χ^2	P^a
Age (year)		9.12 ± 3.81	9.60 ± 4.03	0.521	0.604
Anti-HBs of before vaccine (mIU/ml)		5.23 ± 2.67	4.39 ± 2.47	1.373	0.174
Treatment	Chemotherapy	32 (74.4)	21 (70.0)	0.173	0.677
	Transplantation	11 (25.6)	9 (30.0)
Census	Training group	12 (27.9)	8 (26.7)	0.014	0.907
	Validation group	31 (72.1)	22 (73.3)
History of hepatitis B vaccination	Complete	41 (95.3)	27 (90.0)	0.176	0.675
	Unknown	2 (4.7)	3 (10.0)
Type of tumor	Leukemia	12 (27.9)	3 (10.0)	4.573	0.102
	Solid tumor	18 (41.9)	12 (40.0)
	Aplastic anemia	13 (30.2)	15 (50.0)
Age group	<7-year-old	18 (41.9)	9 (30.0)	1.128	0.569
	7–10-year-old	11 (25.6)	10 (33.3)
	>10-year-old	14 (32.5)	11 (36.7)

1. ‘a’ indicates that the statistically analysis of general characteristics between male and female for subjects.

Figure 2. Analysis of anti-HBs levels before and after the HBV vaccine in children with hematological malignancies.

Figure 3. Analysis of the immunogenic effect of the HBV vaccine in children in different age groups.

Figure 4. Analysis of the immunogenic effect of the HBV vaccine in children with different types of hematological malignancies.

Figure 5. Analysis of the immunogenic effect of HBV vaccine in children with different types of anticancer treatment.

Table 2. Analysis of anti-HBs positive conversion rate in children with hematological malignancies before and after 3-dose HBV vaccinations

Variable		Before vaccination [(n = 73)/%]		1 month after inoculation [(n = 71)/%]		6 months after inoculation [(n = 52)/%]		P^b
		<10 mIU/mL	≥10 mIU/mL	<10 mIU/mL	≥10 mIU/mL	<10 mIU/mL	≥10 mIU/mL
Age group	<7-year-old	27 (37.00)	0 (0.00)	1 (33.33)	25 (36.80)	0 (0.00)	18 (35.30)	<0.001
	7–10-year-old	21 (28.80)	0 (0.00)	1 (33.33)	19 (27.90)	0 (0.00)	16 (31.40)	<0.001
	>10-year-old	25 (34.20)	0 (0.00)	1 (33.33)	24 (35.30)	1 (100.00)	17 (33.33)	<0.001
Treatment	Chemotherapy	53 (72.60)	0 (0.00)	2 (66.67)	50 (73.53)	1 (100.00)	37 (72.55)	<0.001
	Transplantation	20 (27.40)	0 (0.00)	1 (33.33)	18 (26.47)	0 (0.00)	14 (27.45)	<0.001
Gender	Male	43 (58.90)	0 (0.00)	2 (66.67)	39 (57.35)	1 (100.00)	27 (52.94)	<0.001
	Female	30 (41.10)	0 (0.00)	1 (33.33)	29 (42.65)	0 (0.00)	24 (47.06)	<0.001
Total		73 (100.00)	0 (0.00)	3 (4.23)	68 (95.77)	1 (1.92)	51 (98.08)	<0.001

1. ‘b’ indicates that the statistically analysis of anti-HBs positive conversion rate between before vaccination and one-month after vaccination using fisher exact probability method.

Table 3. Analysis of AEFI of HBV vaccination in children with hematological malignancies

Variable		First vaccination [n = 73 (%)]	Second vaccination [n = 73 (%)]	Third vaccination [n = 73 (%)]	χ^2	P^c
AEFI	Yes	5 (6.85)	5 (6.85)	4 (5.48)	0.153	0.927
	No	68 (93.15)	68 (93.15)	69 (94.52)
Fever (°C)	37.1°C-37.5°C	1 (1.37)	1 (1.37)	1 (1.37)	41.593	0.999*
	No	71 (97.26)	71 (97.26)	71 (97.26)
Local swelling (Diameter/cm)	≤2.5	1 (1.37)	2 (2.74)	1 (1.37)	0.709	0.950*
	2.6–5.0	4 (5.48)	3 (4.11)	3 (4.11)
	No	68 (93.15)	68 (93.15)	69 (94.52)

1. ‘c’ indicates that the statistically analysis of AEFI among three doses of HBV vaccines for children with hematological malignancies. 2. ‘*’ Indicates calculation using fisher exact probability method.