Safety and efficacy of hepatitis A vaccine in children with chronic liver disease

Table 1 Ratio of cut-off value and optical density (A₄₅₀ nm) of the sample (or Co/S)

Co/S	Interpretation
< 0.9	Negative
0.9-1.1	Equivocal
> 1.1	Positive

Table 2 Rate of seroconversion in patients and controls 1 and 6 mo after 1^st dose and 1 mo after 2^nd dose of HA vaccine

Time	Patients(n = 11)	Controls(n = 13)	P
	n (%)	n (%)
1 mo after the 1st dose of HA vaccine
Positive	7 (63.6)	13 (100)	0.07
Equivocal	2 (18.2)	0
Negative	2 (18.2)	0
6 mo after the 1st dose of HA vaccine
Positive	7 (63.6)	13 (100)	0.09
Equivocal	3 (27.3)	0
Negative	1 (9.1)	0
1 mo after the 2nd (booster) dose of HA vaccine
Positive	11 (100)	13 (100)	0.63
Equivocal	0	0
Negative	0	0

HA: Hepatitis A.

Table 3 Comparison of the mean value of seroconversion (Co/S) between patients and controls

Time	Patients (n = 11)		Controls (n = 13)
	Range	Mean ± SD	Range	Mean ± SD
1 mo after the 1st dose of HA vaccine	0.6-1.6	1.1 ± 0.4	1.5-3.6	2.5 ± 0.97
6 mo after the 1st dose of HA vaccine	0.9-4.8	3 ± 1.3	2.3-6.9	4.7 ± 1.8
1 mo after the 2nd (booster) dose of HA vaccine	3.2-5.3	4.6 ± 0.8	4.2-5.7	4.9 ± 0.7
P	bP = 0.003		aP = 0.02

^aP = 0.02 within controls by Friedman test;

^bP = 0.003 within patients by Friedman test.

Table 4 Comparison of liver function tests before and after vaccination

	Before vaccination		After vaccination		P
	Range	Median	Range	Median
Patients
Total Serum Bilirubin (mg/L)	4-210	7	3-250	7.5	9.5
ALT (IU/L)	19-163	42	19-136	27.5	0.11
AST (IU/L)	28-299	38	30-288	43	0.07
Controls
Total Serum Bilirubin (mg/L)	3-6	5	1-6	4	4.8
ALT (IU/L)	9-21	18	10-27	17	0.93
AST (IU/L)	21-39	27	21-57	31	0.01b

^bP < 0.01 vs controls before and after vaccination (Wilcoxon Signed Ranks Test). ALT: alanine aminotransferase; AST: aspartate aminotransferase.

Table 5 Comparison of differences in liver functions before and after vaccination between patients and controls (mean ± SD)

	Bilirubin (mg/L)	ALT (IU/L)	AST (IU/L)
Patients	0.8 ± 17	-11.3 ± 26	14.8 ± 23.8
Controls	-0.18 ± 0.9	0.54 ± 7.3	5.1 ± 6.8
P	0.92	0.03a	0.58

^aP < 0.05 vs controls before and after vaccination (Mann-Whitney U test). ALT: alanine aminotransferase; AST: aspartate aminotransferase.