HealthyNCT02368327
Gene Expression Profiles in Muscle After Immunisation
A study testing Fluad and Fendrix in people with Healthy, run by University of Surrey at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fluad and Fendrix
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2015to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Surrey Clinical Research Centre
Guildford, Surrey, Gu2 7XP
About this study
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
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.
- Conditions
- Healthy
- Being tested
- Fluad, Fendrix, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluadBiological
FendrixBiological
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| Fluad | Active comparator | Participants receive one dose of Fluad vaccine Receives: Biological: Fluad |
| Fendrix | Active comparator | Participants receive one dose of Fendrix vaccine Receives: Biological: Fendrix |
| Placebo | Placebo comparator | Participants receive one dose of saline placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline values of gene expression in whole blood and muscle
Measured: Day 0, Day 0+3 hours, Day 1, Day 3, Day 5 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- Max Planck Institute for Infection Biology
- Responsible party
- Sponsor
- Investigators
- Aldona Greenwood, Principal investigator, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368327
- Sponsor's protocol ID
- CRC305E
- Status last verified
- Feb 2015
- First submitted
- 13 Feb 2015
- Last updated
- 10 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02368327
- Acronym / sponsor ID
- CRC305E
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- Max Planck Institute for Infection Biology
- Study start
- Feb 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 23 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluad | Active comparator | Biological: FluadParticipants receive one dose of Fluad vaccine |
| Fendrix | Active comparator | Biological: FendrixParticipants receive one dose of Fendrix vaccine |
| Placebo | Placebo comparator | Biological: PlaceboParticipants receive one dose of saline placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluad | Biological | Fluad |
| Fendrix | Biological | Fendrix |
| Placebo | Biological | Placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aldona Greenwood principal investigator
University of Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluad and Fendrix in people with Healthy, run by University of Surrey at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2015.