NCT01771354

Training Study to Characterise Biomarkers to the Engerix B Vaccine

Clinical Study to Generate Exploratory Training Data Characterising Clinical Events, Physiological & Metabolic Responses, & Innate & Adaptive Immune Responses Following 1st & 3rd of 3 IM Immunisations With "Engerix B" HepB Vaccine or Placebo in Healthy Adults With no Pre-existing Immunity to HepB

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Surrey · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

It is thought that vaccines trigger innate inflammatory responses to induce antigenspecific adaptive immunity (the desired effect), but excessive inflammation may lead to serious inflammatory complications or unwanted side effects. Currently there is a lack of reliable biomarkers (a measurable biological response that predicts something) able to predict severe inflammation and this has resulted in the development of several vaccines being terminated and the withdrawal of some licensed vaccines which were associated with inflammatory complications. This study is part of the BIOVACSAFE project which is a 5year €30M project funded by the Innovative Medicine Initiative. The project involves a series of clinical studies using licensed vaccines as benchmarks to generate clinical data on inflammation and identify biomarkers that can be used to predict acceptable reactogenicity. The target is to identify biomarkers that can predict the occurrence of beneficial and detrimental effects in response to a vaccine. Such biomarkers could be used in future vaccine development programs to optimize selection of vaccine candidates with a profile that will be unlikely to generate worrisome safety signals once they are in generalized use. This study is one in a series of "training" studies which will each use different licensed vaccines that are prototypical representatives of a class of vaccine used in a particular target population. Twenty four subjects will be randomised into two groups to receive: A) Engerix B vaccine (n = 20), B) Saline placebo (n = 4). Following a screening visit, participants will undergo two immunisations at month 0 and month 6. Each immunisation will occur during a seven day residential visit which will include immunization and intensive monitoring of physiological (e.g. heart rate, oral temperature, blood pressure) metabolic and immune (innate and adaptive) parameters. Both residential visits will be followed up by four outpatient visits with further monitoring and blood samples.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Engerix B Vaccine
BIOLOGICAL	Placebo

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-01-18
• Last updated: 2015-02-16

Locations

1 site across 1 country: United Kingdom