NCT02032160

A Study to Characterise Immune Responses Following Immunisations With "Fendrix" or "Engerix B" Hepatitis B Vaccines

Study to Generate Exploratory Training Data Characterising Innate/ Adaptive Immune Responses Following 1st & 3rd Intra-muscular Immunisations With Fendrix/Engerix B Vaccines in Healthy Adult Males With no Pre-existing Immunity to Hep B

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Surrey · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	Engerix B IM injection - 20ug	Engerix B IM injection - 20ug At 0, 1 and 6 months
BIOLOGICAL	Fendrix IM injection - 20ug	Fendrix IM injection - 20ug At 0, 1 and 6 months

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2014-01-09
• Last updated: 2016-02-08

Locations

1 site across 1 country: United Kingdom