Training study to characterize biomic profiles of Fendrix/Energix B.
Research type
Research Study
Full title
A clinical study to generate an exploratory training set of data characterising innate and adaptive immune responses following the first and third of three intra-muscular immunisations with “Fendrix” or “Engerix B” Hepatitis B vaccines in healthy adult males with no pre-existing immunity to Hepatitis B.
IRAS ID
123006
Contact name
David Lewis
Contact email
Sponsor organisation
University of Surrey
Research 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.
In this initial study, 15 subjects per vaccine will be recruited to receive immunization with 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 time points after immunisation on an outpatient basis.
REC name
London - Brent Research Ethics Committee
REC reference
13/LO/0778
Date of REC Opinion
5 Jul 2013
REC opinion
Favourable Opinion