ADITEC FLU STUDY: Understanding the Genetic Basis for Immune Responses

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01682369
• Other study ID #: OVG 2012/04
• Secondary ID: 2012-002443-26
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2012
• Last updated: September 29, 2017
• Start date: September 2012
• Est. completion date: January 2015

Study information

• Verified date: September 2017
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 2015
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Months to 26 Months

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• TIV (Aggripal)

• ATIV (Fluad)

Locations

Country	Name	City	State
United Kingdom	Centre for Clinical Vaccinology & Tropical Medicine (CCVTM)	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

Outcome

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

External Links

•   OVG website