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Trial record 86 of 112 for:    mf59

Gene Expression Profiles in Muscle After Immunisation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02368327
Recruitment Status : Completed
First Posted : February 23, 2015
Last Update Posted : August 10, 2015
Sponsor:
Collaborator:
Max Planck Institute for Infection Biology
Information provided by (Responsible Party):
University of Surrey

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Biological: Fluad Biological: Fendrix Biological: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : February 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

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Arm Intervention/treatment
Active Comparator: Fluad
Participants receive one dose of Fluad vaccine
Biological: Fluad
Active Comparator: Fendrix
Participants receive one dose of Fendrix vaccine
Biological: Fendrix
Placebo Comparator: Placebo
Participants receive one dose of saline placebo
Biological: Placebo



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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): NCT02368327


Locations
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United Kingdom
Surrey Clinical Research Centre
Guildford, Surrey, United Kingdom, Gu2 7XP
Sponsors and Collaborators
University of Surrey
Max Planck Institute for Infection Biology
Investigators
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Principal Investigator: Aldona Greenwood University of Surrey

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Responsible Party: University of Surrey
ClinicalTrials.gov Identifier: NCT02368327     History of Changes
Other Study ID Numbers: CRC305E
First Posted: February 23, 2015    Key Record Dates
Last Update Posted: August 10, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs