A Study to Characterise Immune Responses Following Immunisations With "Fendrix" or "Engerix B" Hepatitis B Vaccines
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional

Summary: 
      The purpose of this study is to generate an exploratory training set of data and to identify
      predictive biomarkers (a measurable biological response that predicts something) of innate
      and adaptive responses to immunisation of two vaccines utilizing different adjuvant
      technology given according to approved schedules to healthy adult volunteers. The vaccines
      are model agents selected as they match antigens but have discordant adjuvants, have a known
      immunogenicity profile, assays are freely available to measure responses, and they are safe
      to administer to healthy adults at the doses and schedules proposed. This study will strive
      to correlate biomarker activity with observed immunological responses to vaccination and if
      successful, these biomarkers could be used in early stage clinical trials to optimize
      selection of vaccine candidates with a profile that will be most likely to be effective once
      they are in generalized use.
    

Detailed description: 
      The purpose of this study is to generate an exploratory training set of data and to identify
      predictive biomarkers (a measurable biological response that predicts something) of innate
      and adaptive responses to immunisation of two vaccines utilizing different adjuvant
      technology given according to approved schedules to healthy adult volunteers. The vaccines
      are model agents selected as they match antigens but have discordant adjuvants, have a known
      immunogenicity profile, assays are freely available to measure responses, and they are safe
      to administer to healthy adults at the doses and schedules proposed. This study will strive
      to correlate biomarker activity with observed immunological responses to vaccination and if
      successful, these biomarkers could be used in early stage clinical trials to optimize
      selection of vaccine candidates with a profile that will be most likely to be effective once
      they are in generalized use.

      In this study, 15 subjects per vaccine will be recruited to receive immunization with one of
      two hepatitis B vaccines, Engerix B or Fendrix, representing exactly matched antigens
      (hepatitis B surface antigen) but discordant adjuvant technologies. Following a screening
      visit, subjects will be randomly allocated to receive three doses of a vaccine at 0, 1 and 2
      months. Innate immune responses (cytokine levels and whole blood gene expression) after doses
      #1 and #3 and adaptive immune responses (serum antibody and antigen specific cellular
      responses) will be measured at various timepoints after immunisation on an outpatient basis.

      The study is funded by ADITEC, which is a collaborative research programme that aims to
      accelerate the development of novel and powerful immunisation technologies for the next
      generation of human vaccines.
    

Intervention name(s): Engerix B IM injection - 20ug; Fendrix IM injection - 20ug
Intervention type(s): Biological; Biological
Intervention description(s): Engerix B IM injection - 20ug At 0, 1 and 6 months; Fendrix IM injection - 20ug At 0, 1 and 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: ADITEC; Immunology; Vaccines; Hepatitis B; Investigational study; innate and adaptive immune responses; Hepatitis B vaccinations