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ADITEC FLU STUDY: Understanding the Genetic Basis for Immune Responses

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01682369
First received: September 6, 2012
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Influenza
 Biological: TIV (Aggripal)
Biological: ATIV (Fluad)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • 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.


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

Estimated Enrollment: 90
Study Start Date: September 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Begripal
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 Name: Begripal
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 Name: Begripal
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)
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)
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)

  Eligibility

Ages Eligible for Study:   14 Months to 26 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682369

Locations
United Kingdom
Centre for Clinical Vaccinology & Tropical Medicine (CCVTM)
Oxford, Oxfordshire, United Kingdom, OX3 7LE
Sponsors and Collaborators
University of Oxford
Investigators
Principal Investigator: Andrew J Pollard, PhD Oxford Vaccine Group
Principal Investigator: Matthew Snape, PhD Oxford Vaccine Group
  More Information

Additional Information:
OVG website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01682369     History of Changes
Other Study ID Numbers: OVG 2012/04, 2012-002443-26
Study First Received: September 6, 2012
Last Updated: January 28, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013