The persistence of vaccine-induced HBsAg-specific antibodies and immune memory in adults after complete primary vaccination with the GlaxoSmithKline (GSK) hexavalent Infanrix vaccine at infancy (HEP-IMMUNE)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medicinal product name:
  INFANRIX HEXA

  ENGERIX B
• Medical condition to be studied:
  Hepatitis B

Population studied

• Short description of the study population:
  Healthy adult volunteers are recruited from a population of students from the University of Antwerp who require an evaluation of their seroprotection against hepatitis B at the occupational health services. Participants can only be enrolled if they received the Infanrix-Hexa vaccination schedule as per the recommendations in the Summary of Product Characteristics, and did not receive any other vaccine targeting hepatitis B.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  250

Study design details

• Study design:
  Anti-HBs titers are measured in all eligible participants. Cellular immunity is assessed in a subset with anti-HBs titers ≥ 10 mIU/mL. Participants with titers < 10 mIU/mL receive one Engerix-B booster, followed by assessment of humoral and cellular immunity for up to 1 month after vaccination.
• Main study objective:
  1. To assess the persistence of immunity to hepatitis B in terms of seroprotection rate (refer to below for a definition) in adult subjects vaccinated with three or four doses of Infanrix hexa during infancy.; ; 2. To assess the persistence of immunity to hepatitis B in terms of seroprotection rate, percentage of subjects with an anamnestic response in response to an Engerix-B challenge dose in adult subjects vaccinated with three or four doses of Infanrix hexa during infancy who have an anti-HBs concentration < 10 mIU/mL at the start of the study.