Long-term antibody persistence against hepatitis B in adolescents 14–15-years of age vaccinated with 4 doses of hexavalent DTPa-HBV-IPV/Hib vaccine in infancy

Figures & data

Figure 1. Focus on Patient Section.

Table 1. Characteristics of study participants.

	TVC (N = 302)	ATP cohort for immunogenicity (N = 268)
Mean age ± SD, years	14.4 ± 0.5	14.4 ± 0.5
Male, n (%)	160 (53.0)	137 (51.1)
Geographic ancestry, n (%)
African heritage/African American	2 (0.7)	2 (0.7)
Asian – Central/South Asian Heritage	1 (0.3)	1 (0.4)
Asian – South East Asian Heritage	1 (0.3)	1 (0.4)
White – Arabic/North African Heritage	4 (1.3)	4 (1.5)
White – Caucasian/European Heritage	293 (97.0)	259 (96.6)
Caucasian/North African Mixture	1 (0.3)	1 (0.4)
Mean weight ± SD, kg	63.2 ± 15.4	62.9 ± 15.1
Mean height ± SD, cm	168.4 ± 9.0	168.1 ± 9.0
Mean body mass index ± SD, kg/m^Citation2	22.2 ± 4.7	22.2 ± 4.6

TVC, total vaccinated cohort; N, number of participants in each cohort; ATP, according-to-protocol; SD, standard deviation; n (%), number (percentage) of participants in each category.

Figure 2. Participant flow chart.

ATP, according-to-protocol; N, number of participants; HBc, hepatitis B core antigen.Note: *One participant also had positive anti-HBc status 1 month post-challenge dose.

Table 2. Seropositivity/seroprotection rates and antibody GMCs, overall and by pre-challenge status (ATP cohort for immunogenicity).

		Seropositivity/seroprotection rate (% [95% CI])
	N	≥6.2 mIU/mL	≥10 mIU/mL	≥100 mIU/mL	GMC (95% CI)
Pre-challenge	268	60.8 (54.7–66.7)	53.7 (47.6–59.8)	16.8 (12.5–21.8)	15.6 (12.8–19.1)
One month post-challenge	268	95.1 (91.8–97.4)	93.3 (89.6–96.0)	87.3 (82.7–91.1)	1975.7 (1436.1–2718.1)
By pre-challenge status
<6.2 mIU/mL	105	87.6 (79.8–93.2)	82.9 (74.3–89.5)	68.6 (58.8–77.3)	224.7 (143.0–353.1)
≥6.2 – <10 mIU/mL	19	100 (82.4–100)	100 (82.4–100)	100 (82.4–100)	1661.0 (1092.0–2526.4)
≥10 mIU/mL	144	100 (97.5–100)	100 (97.5–100)	99.3 (96.2–100)	9865.7 (7418.8–13,119.5)

ATP, according-to-protocol; GMC, geometric mean concentration; N, number of participants with available results; CI, confidence interval; IU, international units.

Table 3. Number and percentage of participants with anamnestic response to the challenge dose, overall and by pre-challenge status (ATP cohort for immunogenicity).

	N	n	% (95% CI)
Overall	268	248	92.5 (88.7–95.4)
By pre-challenge status (anti-HBs antibody concentration)
Seronegative (<6.2 mIU/mL)	105	87	82.9 (74.3–89.5)
Seropositive (≥6.2 mIU/mL)	163	161	98.8 (95.6–99.9)
≥6.2–<10 mIU/mL	19	19	100 (82.4–100)
≥10 mIU/mL	144	142	98.6 (95.1–99.8)

ATP, according-to-protocol; N, number of participants with available results; n (%), number (percentage) of participants with anamnestic response; CI, confidence interval; HBs, hepatitis B surface antigen

Note: Anamnestic response was defined as anti-HBs concentrations ≥10 mIU/mL in participants seronegative (anti-HBs antibody concentrations <6.2 mIU/mL) before the challenge dose and as a ≥ 4-fold increase in anti-HBs concentrations in participants seropositive (anti-HBs antibody concentrations ≥6.2 mIU/mL) before the challenge dose.

Figure 3. Percentage of adolescents with solicited local and general symptoms (total vaccinated cohort).

GI, gastrointestinal; Fever, temperature ≥ 37.5°C; N, number of participants with documented dose.Note: Grade 3 events were defined as preventing normal daily activities (for pain, fatigue, GI symptoms and headache), surface >50 mm (for redness, swelling) and temperature >39°C (fever). Error bars represent 95% confidence intervals.

World Health Organization. Regional Office for Europe. Immunization highlights 2015; [accessed Jan 18]. http://www.euro.who.int/__data/assets/pdf_file/0018/307620/Immunization-highlights-2015.pdf?ua=1.

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