NCT02368327

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 23, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 10, 2015

Status Verified

February 1, 2015

Enrollment Period

5 months

First QC Date

February 13, 2015

Last Update Submit

August 7, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Change from baseline values of gene expression in whole blood and muscle

    Day 0, Day 0+3 hours, Day 1, Day 3, Day 5 and Day 7

Study Arms (3)

Fluad

ACTIVE COMPARATOR

Participants receive one dose of Fluad vaccine

Biological: Fluad

Fendrix

ACTIVE COMPARATOR

Participants receive one dose of Fendrix vaccine

Biological: Fendrix

Placebo

PLACEBO COMPARATOR

Participants receive one dose of saline placebo

Biological: Placebo

Interventions

FluadBIOLOGICAL
Fluad
FendrixBIOLOGICAL
Fendrix
PlaceboBIOLOGICAL
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The participant is able to read and understand the Informed Consent Form (ICF), and understand study procedures.
  • The participant has signed the ICF.
  • Healthy male participants aged 18-45 years inclusive.
  • BMI between 19-27 kg/m2.
  • Pre-immunised with Hepatitis B vaccine
  • Hepatitis B sAb positive (evidence of vaccine-induced immunity)
  • Hepatitis B sAg and cAb negative (evidence of lack of prior/current HBV infection)
  • Hepatitis C and HIV seronegative.
  • Available for follow-up for the duration of the study.
  • Agree to abstain from donating blood during the study.
  • 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.

You may not qualify if:

  • 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
  • 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.
  • Known immune or coagulation disorder or clinically significant abnormalities of platelets, Hb or coagulation on screening labs
  • Known allergy to injected local anaesthetics
  • Unwilling to undergo muscle biopsies
  • Use of steroids or immunosuppressive/immunomodulating drugs either orally or parenterally within 3 months of visit 1.
  • 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.
  • Any condition that, in the investigator's opinion, compromises the participant's ability to meet protocol requirements or to complete the study.
  • Receipt of blood products or immunoglobin, within 3 months of visit 1.
  • Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surrey Clinical Research Centre

Guildford, Surrey, Gu2 7XP, United Kingdom

Location

MeSH Terms

Interventions

fluad vaccineFendrix

Study Officials

  • Aldona Greenwood

    University of Surrey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2015

First Posted

February 23, 2015

Study Start

February 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

August 10, 2015

Record last verified: 2015-02

Locations

GB(1)