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

NCT02032160 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-02-08

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • University of Surrey

    lead OTHER

Principal Investigators

  • David JM Lewis, MD · University of Surrey

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02032160 on ClinicalTrials.gov