ADITEC FLU STUDY: Understanding the Genetic Basis for Immune Responses

September 29, 2017 updated by: University of Oxford

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • Centre for Clinical Vaccinology & Tropical Medicine (CCVTM)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 2 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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)
Biological: TIV (Aggripal)
Other Names:
  • Begripal
Other: 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)
Biological: TIV (Aggripal)
Other Names:
  • Begripal
Other: 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)
Biological: TIV (Aggripal)
Other Names:
  • Begripal
Other: 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)
Biological: ATIV (Fluad)
Other: 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)
Biological: ATIV (Fluad)
Other: 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)
Biological: ATIV (Fluad)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Descriptive analyses of gene expression profiles of participants following immunisation with TIV or ATIV in relation to baseline profiles.
Time Frame: 56 days
To describe gene expression profiles of participants following immunisation with TIV or ATIV in relation to baseline profiles.
56 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 56 days
56 days
To evaluate the reactogenicity & safety of ATIV in terms of local & systemic reactions following vaccination.
Time Frame: 56 days
56 days
To study T&B cell responses following immunisation with each vaccine.
Time Frame: 56 days
56 days
To explore the relationship between gene expression and the T cell, B cell and HIA response to immunisation with TIV and ATIV.
Time Frame: 56 days
56 days
To explore the relationship between gene expression and the reactogenicity of TIV and ATIV.
Time Frame: 56 days
56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Investigators

  • Principal Investigator: Matthew Snape, PhD, Oxford Vaccine Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

September 6, 2012

First Submitted That Met QC Criteria

September 6, 2012

First Posted (Estimate)

September 10, 2012

Study Record Updates

Last Update Posted (Actual)

October 2, 2017

Last Update Submitted That Met QC Criteria

September 29, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OVG 2012/04
  • 2012-002443-26 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Influenza

Clinical Trials on TIV (Aggripal)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe