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Trial record 87 of 112 for:    mf59

ADITEC FLU STUDY: Understanding the Genetic Basis for Immune Responses

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ClinicalTrials.gov Identifier: NCT01682369
Recruitment Status : Completed
First Posted : September 10, 2012
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Tracking Information
First Submitted Date  ICMJE September 6, 2012
First Posted Date  ICMJE September 10, 2012
Last Update Posted Date October 2, 2017
Study Start Date  ICMJE September 2012
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 6, 2012)
To describe gene expression profiles of participants following immunisation with TIV or ATIV in relation to baseline profiles.
Change History Complete list of historical versions of study NCT01682369 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2015)
  • 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 ]
  • To evaluate the reactogenicity & safety of ATIV in terms of local & systemic reactions following vaccination. [ Time Frame: 56 days ]
  • To study T&B cell responses following immunisation with each vaccine. [ Time Frame: 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 ]
  • To explore the relationship between gene expression and the reactogenicity of TIV and ATIV. [ Time Frame: 56 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2012)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ADITEC FLU STUDY: Understanding the Genetic Basis for Immune Responses
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Influenza
Intervention  ICMJE
  • Biological: TIV (Aggripal)
    Other Name: Begripal
  • Biological: ATIV (Fluad)
Study Arms  ICMJE
  • 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)

    Intervention: Biological: 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)

    Intervention: Biological: 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)

    Intervention: Biological: 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)

    Intervention: 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)

    Intervention: 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)

    Intervention: Biological: ATIV (Fluad)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 6, 2012)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Months to 26 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01682369
Other Study ID Numbers  ICMJE OVG 2012/04
2012-002443-26 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Oxford
Study Sponsor  ICMJE University of Oxford
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew J Pollard, PhD Oxford Vaccine Group
Principal Investigator: Matthew Snape, PhD Oxford Vaccine Group
PRS Account University of Oxford
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP