Do you want to learn more about the IRFLUVA Study? This is for you…

Thank you for visiting the IRFLUVA Study blog – we hope that you find some of the content interesting. We are inviting volunteers to contact us if they are interested in learning more about the study or considering taking part. As such, below you can find an information with some of the important details of the study. This include contact details for any queries or comments you may have. Thank you!

 IRFLUVA – Improving the Long Term Immune Response to the Flu Vaccine  Ethics reference: IRAS 314310

What is the purpose of the study?

Our immune response to viruses and bacteria (the way our body responds to infections) reduces as we age. This appears to be part of the normal aging process and can make ‘fighting’ infections more difficult. As you may already know, some infections can affect older people more seriously than people of a younger age, for example, flu and Coronavirus.

Vaccines are very important in older people. We have seen this with the UK vaccination programme for Coronavirus, where older people are made a high priority for timely vaccination. However, doctors and scientists have seen that the immune response to a vaccine can also be reduced in older people, when compared to younger people. This change in the immune response as we age is something we would like to understand more.

There is new evidence that foods containing a substance called spermidine, may be an important part of a healthy diet and important for the immune response.  Spermidine is naturally found in some foods, but not in large amounts. A widely available supplement, SPDLife, made from wheatgerm, contains spermidine and can increase the amount of spermidine eaten every day. It may improve the health of the immune system in older people. We would like to find out more about how older people find taking this  supplement and explore if it can improve the immune response to the flu vaccine. It is not a medication and its safety has been studied carefully.

This research trial will look at if it is simple to take the supplement daily and whether older people find it acceptable. We will also explore whether it can improve the immune response in people aged more than 65 years old. If you take part, we will study the effect of this supplement on your immune response to the flu vaccine you are eligible to have every year.

We will ask you your opinion about the supplement and we will measure your antibody responses and measure the immune cells responses to the flu vaccine This will include studying your white blood cells, which help fight infection and play an essential role in successful vaccination. By analysing a sample of blood, the research will look at how your body responds to the flu vaccine and whether the response is improved by taking the supplement and ensuring you have good amount of spermidine in your diet. We hope this trial will, therefore, give us more information about whether the food supplement can be used in a larger trial in the future and to see if it can improve the immune response to the flu vaccine in older people.

What is the supplement used in this study?

The supplement is made from wheatgerm. It is a powder that dissolves in water and can be taken by mouth at home. The ‘placebo’ is also a powder that dissolves in water and can be similarly taken by mouth at home. Studies have shown the supplement does not have any serious side effects. It also contains thiamine, Zinc and Vitamin C which are important parts of a healthy diet. The placebo contains rice flour and a small amount of sucrose (a type of sugar found in food).

Why have I been chosen? We are inviting people aged 65 years or over, who are eligible to have the flu vaccine every year, to take part in this study. We are aiming to recruit a total of 80 participants to this research study. To take part you must:

 

·         Be aged 65 years or over.

·  Be eligible for a seasonal flu vaccine

· Be willing to receive a normal, licensed flu vaccine

·         Live in Wales

 

You are not able to take part in the study if you have been diagnosed with one of the following conditions:

 

Diabetes – Type 1 and Type 2

Gluten allergy or wheat intolerance – coeliac disease

Cancer

A medical condition that reduces your immune response

Flu within the last 6 months

 

You are also not able to take part if you:

 

Had a blood/platelet or immunoglobulin treatment in the last 3 months

Already had your flu vaccine this year (2024)

Take steroids (by mouth or injection) for more than 1 week in the last 3 months

Have taken spermidine supplements in the last 6 months

Take medications that reduce your immune response

 

Do I have to take part? Joining the study is entirely up to you and deciding not to take part will not affect any future standard of care. We would like you to understand why the research is being done and what it involves. One of our team will go through this information sheet with you, to help you decide whether or not you want to participate.

A diagram showing the timing of what will happen if you take part in the study can be seen below:

We will ask you to record details of any side effects related to the supplement (e.g., new, persistent gastro-intestinal symptoms such as bloating) in a study diary. We will inform your GP that you are taking part in the study and give you a card to carry giving contact details of the research team. We will check your vaccine and GP record.

How do I take the supplement or placebo?

The supplement is a powder that dissolves in water. You will need to take 3 supplements per day. These can be taken at any time of day and can be taken all at one time, or spread throughout the day, depending on your preference. You can dissolve this in a small amount of water or a large glass of water, whichever works best for you. You are able to add some cordial or squash to the supplement if you prefer this.

Will I know whether I am taking SPDLife or a placebo?

During the trial you and the clinical research team will not know whether you are taking SPDLife or the placebo. At the end of the trial, the clinical research team will be able to inform you whether you took the supplement or not. You will be randomly assigned to the SPDLife group or the placebo group using a computerised clinical research trial system.

 What will happen to my blood samples?     

 On your first and second visit to the clinical research facility, your blood will be

analysed at a UK accredited medical laboratory. This sample will be labelled with your

unique study ID and date of birth. The blood tests will measure liver function, kidney

function, bone health, blood sugar, iron, fats and cholesterol in the blood and a full

blood count. Before transfer of research samples to Cardiff University or Oxford

University, your personal details will be removed from your blood samples so that they

will not have any identifying details on them and labelled with a unique study number.

The research team will not know the results of your tests until the end of the study and

you will not be told the results of your tests. 50ml of your blood will undergo testing to

study the effect of the supplement on your body, antibodies and immune cells,

including your T cells and B cells (which are important for fighting infection). We will

examine how your immune cells responded to the flu vaccine with several scientific

tests. We will examine the DNA in your immune cells. If you take part all of these tests will be performed. We will not study immune cells for genetic diseases. Results of these tests will not be reported to you. If you wish to know more on

this please discuss with the Principal Investigator, Dr Lucy Jones.

 

Will you inform my GP that I am taking part?

The research doctor will ask your permission to contact your GP to tell them you are taking part in the research study. The research team at Cardiff and the Vale University Health Board Clinical research facility (Principal Investigator and clinical research delivery team) will ask for your permission to access relevant medical records and check your vaccine record – for example, any flu or COVID vaccines you may have received or swabs for flu virus, with your consent. This information will not be shared outside of the clinical research team in a form in which you can be identified.

 Are there any risks or disadvantages from taking part?

We do not foresee any significant risks to you as a result of taking part in this study. SPDLife has been well studied and there is evidence that it is a safe supplement. There are no known side effects to SPDLife.Taking any supplement may lead to some minor side effects (for example an unpleasant taste, an upset stomach or bloating) and we will monitor these. The disadvantages would be taking a few minutes of your time to consider taking part in the study, the minor discomfort having a blood sample and the inconvenience of taking supplements and making a note of any side effects during the study.

Are there any benefits from taking part?

We cannot promise the study will benefit you directly, but the information gathered through this study aims to improve global knowledge of vaccination and inform future clinical practice for prevention and treatment of infection outbreaks and improve patient care and outcomes.

Who is organising and funding the research?

This study is being organised by Cardiff and the Vale University health board, Cardiff University and the University of Oxford. Cardiff and the Vale University health board is conducting the clinical research and Cardiff University and the University of Oxford is performing the laboratory experiments. Cardiff University is the Sponsor of this study. Funding is provided by The Longevity Labs Limited and Health and Care Research Wales.

Who has reviewed the study?

This study has been reviewed by, and received ethics clearance through, Research Ethics Committee (Reference number 24/WM/0065 ). All research in the NHS is looked at by independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and given favourable opinion by Black Country Research Ethics Committee. This study has been also been given approval to commence by Cardiff and the Vale University Health Board.

 Expenses

You are able to claim your travel expenses incurred while taking part in this study. We are unable to reimburse any accommodation costs you may incur. In order to process any expenses, personal information that is required for financial reimbursement will be confidentially shared with finance staff at Cardiff University.

 

Contact for Further Information: 

Dr Lucy C Jones,

Address: Clinical Research Facility, Upper Ground Floor (C Block) University Hospital of Wales Heath Park, Cardiff CF14 4XW.

Email: JonesL147@cardiff.ac.uk

Telephone: 02921 848251 or 07480926235