Training Study to Characterise Biomarkers to the Engerix B Vaccine
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|ClinicalTrials.gov Identifier: NCT01771354|
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : February 16, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Biological: Engerix B Vaccine Biological: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||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|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
Placebo Comparator: Placebo
Active Comparator: Vaccine
Engerix B vaccine
|Biological: Engerix B Vaccine|
- Change from baseline values of global gene expression in whole blood. [ Time Frame: Visits 1 (Day -28 to -2), 2 (Day -1 to +5) , 3 (Day 7), 4 Day 14), 5 (Day 21), 6 (Day 28), 7 (Day 168 to 173), 8 (Day 175), 9 (Day 182), 10 (day 189), 11 (Day 196). ]
- Proportion of subjects experiencing vaccine-related clinical events following administration of vaccine. [ Time Frame: Visits 2 (Day -1 to +5) , 3 (Day 7), 4 Day 14), 5 (Day 21), 6 (Day 28), 7 (Day 168 to 173), 8 (Day 175), 9 (Day 182), 10 (day 189), 11 (Day 196). ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771354
|University of Surrey, Surrey CRC|
|Guildford, Surrey, United Kingdom, GU2 7XP|
|Principal Investigator:||David JM Lewis, Professor||University of Surrey|