Demonstration of durable hepatitis B immune memory in children vaccinated with a DTaP5-IPV-HepB-Hib infant-toddler series 7 to 8 years previously

Figures & data

Figure 1. Disposition of participants.

Table 1. Demographics of the all enrolled population.

Parameter	N = 207
Male, n (%)	110 (53.1)
Age, y, mean (range)	8.4 (8–9 years)
Race, n (%)
White	205 (99.0)
Other	2 (1.0)
Ethnicity, n (%)
Not Hispanic or Latino	205 (99.0)
Hispanic or Latino	2 (1.0)

N, the number of children enrolled.

Table 2. Response rate at baseline and day 30 after the challenge dose with monovalent hepatitis B vaccine in the per-protocol population and in children stratified by 2 + 1 and 3 + 1 dosing DTaP5-IPV-HepB-Hib schedules.

	Participants with anti-HBs ≥10 mIU/mL
Analysis population	n (%)^a	95% CI^b
Baseline
Per-protocol population	93/205 (45.4)	38.4, 52.5
2 + 1 dosing	38/93 (40.9)	30.8, 51.5
3 + 1 dosing	55/112 (49.1)	39.5, 58.7
Day 30 post-challenge
Per-protocol population^c	201/202 (99.5)	97.3, 100.0
2 + 1 dosing	93/93 (100.0)	96.1, 100.0
3 + 1 dosing^d	108/109 (99.1)	95.0, 100.0

^aResponse rate is the percentage of children with an anti-HBs level of ≥10 mIU/mL.

^bFor the dichotomous endpoints, the within-group 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.²¹

^c202 children contributed to the day 30 post-challenge analysis out of the 205 enrolled.

^d109 children contributed to the day 30 post-challenge analysis out of the 112 enrolled. Anti-HBs, hepatitis Bsurface antibody; n, the number of children enrolled, vaccinated, and contributed to the analysis.

Table 3. Geometric mean concentrations (Anti-HBs) at baseline and day 30 after monovalent hepatitis B vaccine challenge in the per-protocol population and in children stratified by prior 2 + 1 and 3 + 1 dosing DTaP5-IPV-HepB-Hib schedules.

Analysis population	n	Geometric mean concentration of anti-HBs, mIU/mL (95% CI)^a
Baseline
Per-protocol population	205	9.6 (7.9, 11.8)
2 + 1 dosing	93	7.9 (6.0, 10.5)
3 + 1 dosing	112	11.3 (8.5, 15.0)
Day 30 post-challenge
Per-protocol population^b	202	685.8 (605.7, 776.6)
2 + 1 dosing	93	657.5 (549.1, 787.2)
3 + 1 dosing^c	109	711.0 (597.4, 846.1)

^aFor the continuous endpoints, the within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.

^bA total of 202 children contributed to the day 30 post-challenge analysis out of the 205 enrolled.

^cA total of 109 children contributed to the day 30 post-challenge analysis out of the 112 enrolled.

Anti-HBs; hepatitis B surface antibody; n, the number of children enrolled, vaccinated, and contributed to the analysis.

Table 4. Percentage of children with at least a 4-fold rise in anti-HBs concentration after monovalent hepatitis B vaccine challenge in the per-protocol population and in children stratified by Prior 2 + 1 and 3 + 1 dosing DTaP5-IPV-HepB-Hib schedules.

	Participants with ≥4-fold rise (%)	95% CI^a
Day 30 post-challenge
Per-protocol population^b	194/202 (96.0)	92.3, 98.3
2 + 1 dosing	92/93 (98.9)	94.2, 100.0
3 + 1 dosing^c	102/109 (93.6)	87.2, 97.4

^aFor the dichotomous endpoints, the within-group 95% CIs are based on the exact binomial method proposed by Clopper and Pearson²¹.

^bA total of 202 children contributed to the analysis out of the 205 enrolled.

^cA total of 109 children contributed to the analysis out of the 112 enrolled.

Anti-HBs; hepatitis B surface antibody.

Figure 2. Reverse cumulative distribution curves of anti-HBs concentrations at day 30 post-challenge for the per-protocol population and for children stratified by a 2 + 1 dosing (V419–008) and 3 + 1 dosing (V419–007) of DTaP5-IPV-HepB-Hib. at day 30 post-challenge, anti-HBs levels of ≥ 100 mIu/ml (right solid vertical line) were achieved in 94% of children (upper dashed horizontal line) and anti-HBs levels of ≥ 1000 mIU/mL (left solid vertical line) were reached in 75% of children (lower dashed horizontal line).

Anti-HBs, hepatitis B surface antibody.

Clopper CJ, Pearson ES. The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika. 1934;26(4):404–13. doi:10.1093/biomet/26.4.404.

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