ADITEC FLU STUDY: Understanding the Genetic Basis for Immune Responses
NCT ID: NCT01682369
Last Updated: 2017-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2012-09-30
2015-01-31
Brief Summary
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This vaccine has been used extensively in adults over 65 years of age. It has been administered to over 4000 children in previous studies, which have shown that it produces an enhanced immune response in children compared with traditional vaccines, and that it is safe in this age group. It is, however, not yet licensed for use in children. The reason for this new study is to gain a better understanding of the how this vaccine is stimulating the immune system, by looking to see which parts of the genetic code are 'switched on' in response to immunisation, and to see how this differs from the response to currently used flu vaccines.
To do this the Oxford Vaccine Group will enrol children aged 14 to 26 months to receive either the influenza vaccine with the MF59 adjuvant (ATIV) or one of the influenza vaccines currently available in the UK (Agrippal/ Begripal or TIV). The study will also help to find out whether it is possible to identify patterns of genetic response which can predict responses to immunisation. Being able to do so could potentially enable more rapid development of vaccines against influenza and other diseases in the future. We will also measure how well the immune system responds to the two vaccines and look at any side effects.
The study is funded by Aditec is a collaborative research programme that aims to accelerate the development of novel and powerful immunisation technologies for the next generation of human vaccines.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Group 1 a - TIV
V1- Day 0- Administer a dose of 0.25ml of vaccine TIV (Agrippal) + Collect blood sample (up to 6.0 ml)
V2- Day 28 (26-35)- Vaccination 2nd dose, Administer a dose of 0.25ml of vaccine TIV (Agrippal)
V3-(Day V2+1)- Collect blood sample (up to 6.0 ml)
V4- Day V2+28 (26-35)- Collect blood sample (up to 6.0 ml)
TIV (Aggripal)
Group 1 b - TIV
V1- Day 0- Administer a dose of 0.25ml of vaccine TIV (Agrippal) + Collect blood sample (up to 6.0 ml)
V2- Day 28 (26-35)- Vaccination 2nd dose, Administer a dose of 0.25ml of vaccine TIV (Agrippal)
V3-(Day V2+3)- Collect blood sample (up to 6.0 ml)
V4- Day V2+28 (26-35)- Collect blood sample (up to 6.0 ml)
TIV (Aggripal)
Group 1 c - TIV
V1- Day 0- Administer a dose of 0.25ml of vaccine TIV (Aggripal) + Collect blood sample (up to 6.0 ml)
V2- Day 28 (26-35)- Vaccination 2nd dose, Administer a dose of 0.25ml of vaccine TIV (Aggripal)
V3-(Day V2+7)- Collect blood sample (up to 6.0 ml)
V4- Day V2+28 (26-35)- Collect blood sample (up to 6.0 ml)
TIV (Aggripal)
Group 2 a - ATIV
V1- Day 0- Administer a dose of 0.25ml of vaccine ATIV (Fluad) + Collect blood sample (up to 6.0 ml)
V2- Day 28 (26-35)- Vaccination 2nd dose, Administer a dose of 0.25ml of vaccine ATIV (Fluad)
V3- V3(Day V2+1)- Collect blood sample (up to 6.0 ml)
V4- V4 Day V2+28 (26-35)- Collect blood sample (up to 6.0 ml)
ATIV (Fluad)
Group 2 b - ATIV
V1- Day 0- Administer a dose of 0.25ml of vaccine ATIV (Fluad) + Collect blood sample (up to 6.0 ml)
V2- Day 28 (26-35)- Vaccination 2nd dose, Administer a dose of 0.25ml of vaccine ATIV (Fluad)
V3- V3(Day V2+3)- Collect blood sample (up to 6.0 ml)
V4- V4 Day V2+28 (26-35)- Collect blood sample (up to 6.0 ml)
ATIV (Fluad)
Group 2 c - ATIV
V1- Day 0- Administer a dose of 0.25ml of vaccine ATIV (Fluad) + Collect blood sample (up to 6.0 ml)
V2- Day 28 (26-35)- Vaccination 2nd dose, Administer a dose of 0.25ml of vaccine ATIV (Fluad)
V3- V3(Day V2+7)- Collect blood sample (up to 6.0 ml)
V4- V4 Day V2+28 (26-35)- Collect blood sample (up to 6.0 ml)
ATIV (Fluad)
Interventions
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TIV (Aggripal)
ATIV (Fluad)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent obtained from parent / LAR (s) of the subject
* Age from 14 months to 26 months (from start of 14 months up to \& excluding 27 months of age)
* Subject is healthy as determined by medical history and clinical examination
* Have received the standard UK immunisation schedule
Exclusion Criteria
* Use or planned use of any non-registered or investigational product in last 30 days
* Previous influenza vaccination
* Microbiologically proven influenza illness or treatment with antiviral medications
* Confirmed or suspected egg allergy.
* Chronic serious medical conditions which may, in the opinion of the investigator, interfere with evaluation of study objectives e.g. Chronic lung disease, chronic liver/renal disease, chronic renal failure chronic heart disease, congenital genetic syndromes (e.g. Trisomy 21).
* Suspected or confirmed immunosuppressive or immunodeficiency conditions (including splenic dysfunction \& HIV)
* Autoimmune conditions e.g. Type 1/2 diabetes mellitus, thyroid disease, juvenile idiopathic arthritis etc.
* Bleeding disorders
14 Months
26 Months
ALL
Yes
Sponsors
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University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Andrew J Pollard, PhD
Role: PRINCIPAL_INVESTIGATOR
Oxford Vaccine Group
Matthew Snape, PhD
Role: PRINCIPAL_INVESTIGATOR
Oxford Vaccine Group
Locations
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Centre for Clinical Vaccinology & Tropical Medicine (CCVTM)
Oxford, Oxfordshire, United Kingdom
Countries
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References
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Nakaya HI, Clutterbuck E, Kazmin D, Wang L, Cortese M, Bosinger SE, Patel NB, Zak DE, Aderem A, Dong T, Del Giudice G, Rappuoli R, Cerundolo V, Pollard AJ, Pulendran B, Siegrist CA. Systems biology of immunity to MF59-adjuvanted versus nonadjuvanted trivalent seasonal influenza vaccines in early childhood. Proc Natl Acad Sci U S A. 2016 Feb 16;113(7):1853-8. doi: 10.1073/pnas.1519690113. Epub 2016 Jan 11.
Related Links
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OVG website
Other Identifiers
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2012-002443-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
OVG 2012/04
Identifier Type: -
Identifier Source: org_study_id