ADITEC FLU STUDY: Understanding the Genetic Basis for Immune Responses
A Multi-centre, Phase II, Open Labelled Randomised Control Trial to Describe Immune & Transcriptomic Responses to Trivalent Inactivated Vaccine (TIV) & MF59 Adjuvanted Influenza Vaccine (ATIV) in 14 -26 Month Healthy Children
2 other identifiers
interventional
90
1 country
1
Brief Summary
Infants and young children do not respond as well as adults to the flu vaccines currently available in the UK. Fluad, is a different type of influenza vaccine that has been available in the European continent for the last decade, and contains an adjuvant known as MF59. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 6, 2012
CompletedFirst Posted
Study publicly available on registry
September 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedOctober 2, 2017
September 1, 2017
5 months
September 6, 2012
September 29, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Descriptive analyses of gene expression profiles of participants following immunisation with TIV or ATIV in relation to baseline profiles.
To describe gene expression profiles of participants following immunisation with TIV or ATIV in relation to baseline profiles.
56 days
Secondary Outcomes (5)
To describe the immunogenicity of TIV & ATIV in terms of haemagglutination-Inhibition test (HAI) against each of the three vaccine strains (A/H1N1, A/H3N2, B), four weeks after completion of vaccination.
56 days
To evaluate the reactogenicity & safety of ATIV in terms of local & systemic reactions following vaccination.
56 days
To study T&B cell responses following immunisation with each vaccine.
56 days
To explore the relationship between gene expression and the T cell, B cell and HIA response to immunisation with TIV and ATIV.
56 days
To explore the relationship between gene expression and the reactogenicity of TIV and ATIV.
56 days
Study Arms (6)
Group 1 a - TIV
OTHERV1- 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)
Group 1 b - TIV
OTHERV1- 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)
Group 1 c - TIV
OTHERV1- 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)
Group 2 a - ATIV
OTHERV1- 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)
Group 2 b - ATIV
OTHERV1- 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)
Group 2 c - ATIV
OTHERV1- 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)
Interventions
Eligibility Criteria
You may qualify if:
- The investigator believes that the parents / LAR (s) of the child can and will comply with requirements of the protocol (e.g. completion of diary cards, understanding of study procedure, consent process, availability at visits)
- 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
You may not qualify if:
- Child in care
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Clinical Vaccinology & Tropical Medicine (CCVTM)
Oxford, Oxfordshire, OX3 7LE, United Kingdom
Related Publications (1)
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.
PMID: 26755593BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew J Pollard, PhD
Oxford Vaccine Group
- PRINCIPAL INVESTIGATOR
Matthew Snape, PhD
Oxford Vaccine Group
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2012
First Posted
September 10, 2012
Study Start
September 1, 2012
Primary Completion
February 1, 2013
Study Completion
January 1, 2015
Last Updated
October 2, 2017
Record last verified: 2017-09