Safety and immune response to a challenge dose of hepatitis B vaccine in healthy children primed 10years earlier with hexavalent vaccines in a 3, 5, 11-month schedule: An open-label, controlled, multicentre trial in Italy

• Published in: Vaccine 2017-07, Vol.35 (32), p.4034-4040
• Main Authors: Zanetti, Alessandro, Desole, Maria Giuseppina, Romanò, Luisa, d'Alessandro, Antonio, Conversano, Michele, Ferrera, Giuseppe, Panico, Maria Grazia, Tomasi, Alberto, Zoppi, Giorgio, Zuliani, Massimo, Thomas, Stéphane, Soubeyrand, Benoît, Eymin, Cécile, Lockhart, Stephen
• Format: Article
• Language: English
• Subjects: Adolescent; Adolescents; Antibodies; Antigens; Challenge dose; Child; Children; Chronic illnesses; Control methods; Deoxyribonucleic acid; Diphtheria-Tetanus-Pertussis Vaccine - administration & dosage; Diphtheria-Tetanus-Pertussis Vaccine - adverse effects; Diphtheria-Tetanus-Pertussis Vaccine - immunology; DNA; Female; Haemophilus Vaccines - administration & dosage; Haemophilus Vaccines - adverse effects; Haemophilus Vaccines - immunology; Healthy Volunteers; Hepatitis; Hepatitis B; Hepatitis B surface antigen; Hepatitis B Surface Antigens - blood; Hepatitis B Vaccines - administration & dosage; Hepatitis B Vaccines - adverse effects; Hepatitis B Vaccines - immunology; Hexavalent vaccine; Humans; Immune memory; Immune response; Immune system; Immunity; Immunization Schedule; Immunoglobulins; Immunologic Memory; Immunological memory; Immunology; Infant; Infants; Italy; Liver cancer; Male; Multiple sclerosis; Poliovirus Vaccine, Inactivated - administration & dosage; Poliovirus Vaccine, Inactivated - adverse effects; Poliovirus Vaccine, Inactivated - immunology; Teenagers; Time Factors; Vaccinated children; Vaccines; Vaccines, Combined - administration & dosage; Vaccines, Combined - adverse effects; Vaccines, Combined - immunology; Viruses
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2017.05.047

•Anti-HBs concentration 80% of children 10y after priming with hexavalent vaccines.•A 3-dose priming with Hexavac was less immunogenic than similar Infanrix hexa priming. The strategy of vaccinating infants to prevent hepatitis B virus infection in adolescence or adulthood requires durable immunity. This study investigated responses to a challenge dose of monovalent hepatitis B vaccine in children primed with three doses of either Hexavac® or Infanrix hexa® 10years earlier during infancy. This open-label, controlled, multicentre study conducted in Italy, enrolled 751 healthy pre-adolescents (aged 11–13years) who were given either Hexavac (n=409) or Infanrix hexa (n=342) at 3, 5 and 11months of life. All participants received a challenge dose of a monovalent hepatitis B vaccine (HBVaxPro® 5µg). The concentrations of antibodies to hepatitis B surface antigen (anti-HBs) were measured before and 1month after the challenge dose. The analysis was descriptive and no formal hypothesis was tested. One month post-challenge, 331 participants in the Hexavac cohort [83.6%, 95% CI: 79.6; 87.1] and 324 in the Infanrix hexa cohort [96.4%, 95% CI: 93.8; 98.1] had anti-HBs concentrations ≥10mIU/mL. Before the challenge dose, an anti-HBs concentration of ≥10mIU/mL was found in 94 children in the Hexavac cohort [23.9%, 95% CI: 19.7; 28.4] and in 232 children in the Infanrix hexa cohort [69%, 95% CI: 63.8; 74.0]. Among children with a pre-challenge anti-HBs concentration of 80%) at least 10years after a two-dose primary and booster vaccination schedule with a hexavalent vaccine (Hexavac or Infanrix hexa). Trial registration: EudraCT Number: 2013-001602-28; clinicaltrials.gov: NCT02012998