ADITEC FLU STUDY: Understanding the Genetic Basis for Immune Responses

University of Oxford

Status and phase: Completed; Phase 2

Conditions: Influenza

Treatments: Biological: TIV (Aggripal); Biological: ATIV (Fluad)

Study type: Interventional

Funder types: Other

Identifiers

NCT01682369

2012-002443-26 (EudraCT Number)

OVG 2012/04

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 14 to 26 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 6 patient groups

Group 1 a - TIV

Other group

Description:

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)

Treatment:

Biological: TIV (Aggripal)

Group 1 b - TIV

Other group

Description:

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)

Treatment:

Biological: TIV (Aggripal)

Group 1 c - TIV

Other group

Description:

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)

Treatment:

Biological: TIV (Aggripal)

Group 2 a - ATIV

Other group

Description:

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)

Treatment:

Biological: ATIV (Fluad)

Group 2 b - ATIV

Other group

Description:

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)

Treatment:

Biological: ATIV (Fluad)

Group 2 c - ATIV

Other group

Description:

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)

Treatment:

Biological: ATIV (Fluad)