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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.
- Source :
-
Human vaccines & immunotherapeutics [Hum Vaccin Immunother] 2019; Vol. 15 (1), pp. 235-241. Date of Electronic Publication: 2018 Sep 11. - Publication Year :
- 2019
-
Abstract
- We 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.
- Subjects :
- Adolescent
Antibodies, Bacterial blood
Diphtheria-Tetanus-Pertussis Vaccine administration & dosage
Female
Haemophilus Vaccines administration & dosage
Hepatitis B immunology
Hepatitis B Surface Antigens immunology
Hepatitis B Vaccines administration & dosage
Humans
Immunization Schedule
Infant
Infant, Newborn
Male
Poliovirus Vaccine, Inactivated administration & dosage
Time Factors
Vaccination statistics & numerical data
Vaccines, Combined administration & dosage
Vaccines, Combined immunology
Diphtheria-Tetanus-Pertussis Vaccine immunology
Haemophilus Vaccines immunology
Hepatitis B prevention & control
Hepatitis B Antibodies blood
Hepatitis B Vaccines immunology
Immunologic Memory
Poliovirus Vaccine, Inactivated immunology
Subjects
Details
- Language :
- English
- ISSN :
- 2164-554X
- Volume :
- 15
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Human vaccines & immunotherapeutics
- Publication Type :
- Academic Journal
- Accession number :
- 30118633
- Full Text :
- https://doi.org/10.1080/21645515.2018.1509658