Gene Expression Profiles in Muscle After Immunisation

August 7, 2015 updated by: University of Surrey

Clinical Study to Generate Exploratory Training Set of Data on the Time Course of Gene Expression Profile at Site of Antigen Deposition Compared With Whole Blood Following IM Injection With Alum or MF59-adjuvanted Protein Subunit Vaccines

This clinical study is part of the BIOVACSAFE project which is funded by the Innovative Medicine Initiative. In this study we will take a small muscle biopsy in order to identify any differences in the response around the actual site of injection compared with responses we measure in blood at the same time.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XP
        • Surrey Clinical Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. The participant is able to read and understand the Informed Consent Form (ICF), and understand study procedures.
  2. The participant has signed the ICF.
  3. Healthy male participants aged 18-45 years inclusive.
  4. BMI between 19-27 kg/m2.
  5. Pre-immunised with Hepatitis B vaccine
  6. Hepatitis B sAb positive (evidence of vaccine-induced immunity)
  7. Hepatitis B sAg and cAb negative (evidence of lack of prior/current HBV infection)
  8. Hepatitis C and HIV seronegative.
  9. Available for follow-up for the duration of the study.
  10. Agree to abstain from donating blood during the study.
  11. The participant is, in the opinion of the investigator, healthy on the basis of a, medical history, a symptom directed medical examination and vital signs.

Exclusion Criteria:

  1. History of hypersensitivity to any of the vaccine components or a history of any allergy that in the opinion of the investigator would contraindicate participant participation
  2. Clinically significant psychiatric, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological (particularly myasthenia gravis), immunological, or haematological disease or abnormality, as determined by the study physician.
  3. Known immune or coagulation disorder or clinically significant abnormalities of platelets, Hb or coagulation on screening labs
  4. Known allergy to injected local anaesthetics
  5. Unwilling to undergo muscle biopsies
  6. Use of steroids or immunosuppressive/immunomodulating drugs either orally or parenterally within 3 months of visit 1.
  7. Currently participating in a clinical trial with an investigational or non- investigational drug or device, or has participated in another clinical trial within the 3 months preceding the study.
  8. Any condition that, in the investigator's opinion, compromises the participant's ability to meet protocol requirements or to complete the study.
  9. Receipt of blood products or immunoglobin, within 3 months of visit 1.
  10. Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fluad
Participants receive one dose of Fluad vaccine
Active Comparator: Fendrix
Participants receive one dose of Fendrix vaccine
Placebo Comparator: Placebo
Participants receive one dose of saline placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline values of gene expression in whole blood and muscle
Time Frame: Day 0, Day 0+3 hours, Day 1, Day 3, Day 5 and Day 7
Day 0, Day 0+3 hours, Day 1, Day 3, Day 5 and Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Aldona Greenwood, University of Surrey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

February 13, 2015

First Submitted That Met QC Criteria

February 13, 2015

First Posted (Estimate)

February 23, 2015

Study Record Updates

Last Update Posted (Estimate)

August 10, 2015

Last Update Submitted That Met QC Criteria

August 7, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • CRC305E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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