Abstract
ABSTRACTWe evaluated antibody persistence against hepatitis B virus (HBV) in adolescents previously vaccinated with a hexavalent diphtheria-tetanus-acellular pertussis-HBV-inactivated poliovirus-Haemophilus influenzae type b conjugate vaccine (DTPa-HBV-IPV/Hib), as part of the national newborn immunization program in Germany. We also assessed the anamnestic response to a challenge dose of a monovalent HBV vaccine. In this phase 4, open-label, non-randomized study (NCT02798952), 302 adolescents aged 14–15 years, primed in their first 2 years of life with 4 DTPa-HBV-IPV/Hib doses, received one challenge dose of monovalent HBV vaccine. Blood samples were taken before and one month post-vaccination and used to determine antibody levels against hepatitis B surface antigen (HBs). Reactogenicity and safety were also assessed post-challenge dose. Pre-challenge dose, 53.7% of 268 participants included in the according-to-protocol cohort for immunogenicity had anti-HBs antibody concentrations ≥10 mIU/mL (seroprotection cut-off) and 16.8% had anti-HBs antibody concentrations ≥100 mIU/mL. One month post-challenge dose, 93.3% of adolescents had anti-HBs antibody concentrations ≥10 mIU/mL and 87.3% had antibody concentrations ≥100 mIU/mL. An anamnestic response was mounted in 92.5% of adolescents. Injection site pain (in 33.6% of participants) and fatigue (30.2%) were the most frequently reported solicited local and general symptoms, respectively. Six of the 55 unsolicited adverse events reported were considered vaccination-related. Two vaccination-unrelated serious adverse events were reported during the study. Long-term antibody persistence against hepatitis B was observed in 14–15 years old adolescents previously primed in infancy with DTPa-HBV-IPV/Hib. A challenge dose of monovalent HBV vaccine induced strong anamnestic response, with no safety concerns.
Highlights
Hepatitis B is a potentially life-threatening disease caused by the hepatitis B virus (HBV) with a high burden of disease; approximately 257 million people worldwide are estimated to be infected with HBV.[1]
302 adolescents previously primed with 4 doses of DTPa-HBV-IPV/Hib during infancy were vaccinated with the monovalent hepatitis B vaccine in the present study and 268 adolescents were included in the according-to-protocol (ATP) cohort for immunogenicity (Figure 2)
This study was conducted as part of a long-term surveillance program of vaccination with DTPa-HBV-IPV/Hib, to assess persistence of immune response to vaccination against HBV from infancy to adolescence, in individuals who had received 4 doses of DTPa-HBV-IPV/Hib during the first 2 years of life in German clinical practices
Summary
Hepatitis B is a potentially life-threatening disease caused by the hepatitis B virus (HBV) with a high burden of disease; approximately 257 million people worldwide are estimated to be infected with HBV.[1]. In Europe, most countries have included hepatitis B vaccination in their routine childhood immunization program as a 3- or 4-dose schedule, to be completed in the first 2 years of life.[6,7,8] Vaccination within the first 12–24 hours from birth is implemented in Europe, in most countries a dose at birth is only recommended for ‘at-risk’ populations, such as infants born to HBVinfected mothers or with unknown immune status.[6]
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