PMID- 27653771 OWN - NLM STAT- MEDLINE DCOM- 20171002 LR - 20181113 IS - 2164-554X (Electronic) IS - 2164-5515 (Print) IS - 2164-5515 (Linking) VI - 12 IP - 11 DP - 2016 Nov TI - Lasting immune memory against hepatitis B in 12-13-year-old adolescents previously vaccinated with 4 doses of hexavalent DTPa-HBV-IPV/Hib vaccine in infancy. PG - 2916-2920 AB - BACKGROUND: Vaccinating infants against hepatitis B virus (HBV) is the most effective way of preventing the disease. However, since HBV exposure can increase during adolescence, it is essential that antibody persistence is maintained. We evaluated the antibody persistence and immune memory against hepatitis B, in 12-13 y olds who had received complete primary + booster vaccination with diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus/Haemophilus influenza type b (DTPa-HBV-IPV/Hib) vaccine in infancy. METHODS: Open phase-IV study conducted at 12 centers in Germany [NCT02052661]. Adolescents aged 12-13 y, vaccinated with 4 doses of DTPa-HBV-IPV/Hib (Infanrix hexa, GSK Vaccines) in infancy, received a single challenge dose of monovalent pediatric hepatitis B vaccine (Engerix-B Kinder; GSK Vaccines). Blood samples were taken before and 1-month post-challenge to measure anti-hepatitis B (anti-HBs) antibodies using a chemiluminescence immunoassay (seroprotection cut-off: >/=10 mIU/ml). Post-challenge adverse events (AEs) were monitored. RESULTS: 300 subjects were vaccinated; of 293 subjects in the ATP immunogenicity cohort, 60.5% had pre-challenge anti-HBs antibodies >/=10 mIU/ml, which rose to 97.6% post-challenge (>/=100 mIU/ml in 94.1%). An anamnestic response was seen in 96.5% subjects. A 150-fold increase in antibody geometric mean concentrations was observed (22.4 to 3502.6 mIU/ml). Pain (44%) and fatigue (24.3%) were the most frequent solicited local and general AEs, respectively; 14.7% subjects reported unsolicited symptoms during the 31-day post-vaccination period. Two vaccine-unrelated serious AEs occurred. CONCLUSION: Vaccination with DTPa-HBV-IPV/Hib in infancy induces sustained seroprotection and immune memory against HBV, as shown by the strong anamnestic response to the hepatitis B vaccine challenge in 12-13 year-old adolescents. FAU - Behre, Ulrich AU - Behre U AD - a Pediatric Practice , Kehl , Baden-Wurttemberg , Germany. FAU - Van Der Meeren, Olivier AU - Van Der Meeren O AD - b GSK Vaccines , Wavre , Belgium. FAU - Crasta, Priya AU - Crasta P AD - c GSK Vaccines , Bangalore , India. FAU - Hanssens, Linda AU - Hanssens L AD - b GSK Vaccines , Wavre , Belgium. FAU - Mesaros, Narcisa AU - Mesaros N AD - b GSK Vaccines , Wavre , Belgium. LA - eng PT - Clinical Trial, Phase IV PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20160921 PL - United States TA - Hum Vaccin Immunother JT - Human vaccines & immunotherapeutics JID - 101572652 RN - 0 (Diphtheria-Tetanus-Pertussis Vaccine) RN - 0 (Haemophilus Vaccines) RN - 0 (Hepatitis B Antibodies) RN - 0 (Hepatitis B Vaccines) RN - 0 (Poliovirus Vaccine, Inactivated) RN - 0 (Vaccines, Combined) RN - 0 (diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine) SB - IM MH - Adolescent MH - Age Factors MH - Child MH - Diphtheria-Tetanus-Pertussis Vaccine/*administration & dosage/*immunology MH - Female MH - Germany MH - Haemophilus Vaccines/*administration & dosage/*immunology MH - Hepatitis B/*prevention & control MH - Hepatitis B Antibodies/*blood MH - Hepatitis B Vaccines/*administration & dosage/*immunology MH - Humans MH - *Immunologic Memory MH - Male MH - Poliovirus Vaccine, Inactivated/*administration & dosage/*immunology MH - Vaccines, Combined/administration & dosage/immunology PMC - PMC5137516 OTO - NOTNLM OT - Adolescents OT - DTPa-HBV-IPV/Hib OT - anamnestic response OT - challenge dose OT - hepatitis B OT - immune memory OT - long-term OT - persistence OT - seroprotection EDAT- 2016/09/23 06:00 MHDA- 2017/10/03 06:00 PMCR- 2016/09/21 CRDT- 2016/09/23 06:00 PHST- 2016/09/23 06:00 [pubmed] PHST- 2017/10/03 06:00 [medline] PHST- 2016/09/23 06:00 [entrez] PHST- 2016/09/21 00:00 [pmc-release] AID - 1202388 [pii] AID - 10.1080/21645515.2016.1202388 [doi] PST - ppublish SO - Hum Vaccin Immunother. 2016 Nov;12(11):2916-2920. doi: 10.1080/21645515.2016.1202388. Epub 2016 Sep 21.