Improving the long-term immune response to the flu vaccine in older people
| ISRCTN | ISRCTN11994133 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11994133 |
| IRAS number | 314310 |
| Secondary identifying numbers | SPON1966-23, CPMS 64340 |
- Submission date
- 09/08/2024
- Registration date
- 30/10/2024
- Last edited
- 28/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Influenza is a great threat to public health and most deaths occur in older people. Effective vaccination protecting older people from flu is a global health challenge. Long-lasting immunity following flu vaccination is difficult to achieve, only 52% of older people have protective antibodies after vaccination. The immune system becomes less efficient with age and immune responses to vaccines reduce. We want to confirm our exciting preliminary results showing that a dietary supplement, made from wheatgerm, can restore and improve levels of polyamine intake in older people. Older people have low levels due to reduced dietary intake. Polyamines can be absorbed from natural food types, e.g., wheatgerm and pomegranates. However, a large volume of food needs to be consumed to increase the level of polyamine dietary intake. A double-blinded, randomised study we conducted showed that the supplement is safe when given after a COVID vaccine and that immune biomarkers increase in older people, with a statistical significance compared to placebo. Our primary outcome will determine if this holds true when the supplement is given after a licensed flu vaccine. We will determine the feasibility of recruitment to the trial, retention of participants, tolerability of supplements, adverse reactions and the side-effect profile of the supplement when taken after the flu vaccine. Our secondary outcome will be exploratory, measuring immune biomarkers: antibodies, T/B cells, after the flu vaccine. We will compare the effects of the supplement to that of a placebo supplement. Blood samples will be analysed at Cardiff University and University of Oxford. This study will justify a Phase 1 clinical trial, where the supplement is administered with the flu vaccine to study the longevity of the immune response and measure clinical outcomes. This research develops health knowledge relating to flu prevention and enables people to manage their dietary intake at home with an oral food supplement.
Who can participate?
People who are 65 years and over are able to participate.
What does the study involve?
Participants taking part in the study will attend 4 research appointments over 37 weeks, at baseline, week 2, week 13 and week 37.
1. Following informed consent, at the baseline appointment participants will be asked questions about their health and these recorded in a form, have their pulse, blood pressure, oxygen levels, temperature and weight measured.
At the baseline visit they will receive a licensed flu vaccine. They will donate 60 mls of venous blood at baseline appointment for biochemistry and haematology profiles and immunogenicity assays.
They will be given a placebo or polyamine supplement to take home and instructions on how to take this for 2 weeks and asked to fill in a diary of missed doses and side effects.
2. At the week 2 visit, participants will be asked questions about their health and these recorded in a form, have their pulse, blood pressure, oxygen levels, temperature and weight measured. They will donate 60 mls of venous blood at baseline appointment for biochemistry and haematology profiles and immunogenicity assays. Missed doses or side effects will be recorded by the research team. They will be given a placebo or polyamine supplement to take home and instructions on how to take this for 11 weeks and asked to fill in a diary of missed doses and side effects.
3. At the week 13 visit, participants will be asked questions about their health and these recorded in a form, have their pulse, blood pressure, oxygen levels, temperature and weight measured. They will donate 50 mls of venous blood for immunogenicity assays. Missed doses or side effects will be recorded by the research team. They will be given a placebo or polyamine supplement to take home and instructions on how to take this for 11 weeks and asked to fill in a diary of missed doses and side effects.
4. At the week 37 visit, participants will be asked questions about their health and these recorded in a form, have their pulse, blood pressure, oxygen levels, temperature and weight measured. They will donate 50 mls of venous blood for immunogenicity assays. This is the end of the study.
Participants will be able to claim expenses at the end of the study and will be informed of the study results.
What are the possible benefits and risks of participating?
We cannot guarantee there are any benefits to taking part in the study.
Where is the study run from?
Cardiff University (UK)
When is the study starting and how long is it expected to run for?
May 2024 to November 2025
Who is funding the study?
Health and Care Research Wales (UK)
Who is the main contact?
Dr Lucy Jones, jonesl147@cardiff.ac.uk
Contact information
Public, Scientific, Principal Investigator
Department of Microbiology, 6th Floor, University hospital of Wales
Cardiff
CF14 4XN
United Kingdom
 ORCID ID |
0000-0002-3872-4376 |
|---|---|
| Phone | 02920742394 |
| JonesL147@cardiff.ac.uk |
Study information
| Study design | Interventional non-CTIMP single-centre double-blind randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, University/medical school/dental school |
| Study type | Safety, Efficacy |
| Participant information sheet | https://blogs.cardiff.ac.uk/irfluva-study/volunteers-wanted-for-a-healthy-immune-ageing-study-2/ |
| Scientific title | IRFLUVA: Improving the long-term immune response to the flu vaccine in older people. A double-blinded, randomised controlled feasibility trial of the effects of a polyamine rich food supplement on flu vaccine antibody levels and immune cell responses, compared to a placebo supplement, in people aged 65 years and over. |
| Study acronym | IRFLUVA |
| Study objectives | Is a wheat-germ extract supplement safe after a flu vaccine and can it improve the amplitude and longevity of antibody and cellular immune response to the flu vaccine in people aged over 65 years? |
| Ethics approval(s) |
Approved 07/05/2024, Black Country HRA Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 2071048129; blackcountry.rec@hra.nhs.uk), ref: 24/WM/0065 |
| Health condition(s) or problem(s) studied | Healthy ageing. Immune ageing |
| Intervention | Arm 1: Polyamine supplement – 6mg supplement taken orally for 13 weeks after a licensed flu vaccine. Follow-up for 37 weeks in total. Arm 2: Placebo – 6mg of a rice flour placebo taken orally for 13 weeks after a licensed flu vaccine. Follow-up for 37 weeks in total. Randomisation using REDCAP randomisation tool. The trial is double-blinded with stratified randomisation by biological sex. |
| Intervention type | Supplement |
| Primary outcome measure | Feasibility measures: 1. Data from the IRFLUVA study case report forms will be used to measure study recruitment rates and retention rates. 2. Data from the IRFLUVA study case report forms will be used to measure study withdrawals and the reason for withdrawal. 3. Data from the IRFLUVA study case report forms will be used to measure the number, severity and nature of adverse reactions for all participants at baseline, 2 weeks, 13 weeks and 37 weeks. 4. Data from the IRFLUVA study case report form will be used to measure the number, severity and nature of adverse events for all participants at baseline, 2 weeks, 13 weeks and 37 weeks. 5. Data from the IRFLUVA study case report form will be used to measure Compliance with polyamine supplement and placebo supplements from baseline to week 13. 6. Results from biochemistry and haematology profile testing at baseline, 2 weeks, 13 weeks and 37 weeks. 7. The number of protocol deviations will be measured at the end of the study. |
| Secondary outcome measures | Measured for up to 37 weeks: 1. T cell Elispots to measure responses to flu 2. B cell Elispots to measure B cell responses to flu 3. IgG ELISA to measure antibodies to flu 4. Plaque assays to study neutralizing antibodies 5. Cytokine assays to measure cytokine responses |
| Overall study start date | 07/05/2024 |
| Completion date | 30/11/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Upper age limit | 101 Years |
| Sex | Both |
| Target number of participants | 80 |
| Key inclusion criteria | 1. 65 years of age or over 2. Capacity to provide written informed consent 3. Eligible for a seasonal flu vaccine 4. Willing to receive a licensed flu vaccine as part of the study protocol on visit 1 of the protocol |
| Key exclusion criteria | 1. Acutely unwell 2. Had a flu vaccine in the 6 months prior to recruitment 3. Known to be immunosuppressed 4. History of influenza in the 6 months prior to recruitment 5. Cannot provide informed written consent 6. Not willing to receive a licensed flu vaccine as part of the study protocol on visit 1 of the protocol 7. Use systemic steroids for more than one week e.g., prednisolone >0.5mg/kg/day in the three months prior to first study intervention 8. Chronic administration (≥14 days in total) of immunosuppressants or other immune modifying drugs in the 3 months prior to first study intervention 9. Receipt of blood, blood products and/or plasma derivatives or any immunoglobulin preparation in the three months prior to first study intervention 10. Diagnosed with diabetes 11. Diagnosed with allergy to, or constituent parts of, SpermidineLife supplements or who have gluten intolerance 12. Already taking Spermidine supplements at the time of recruitment or for 6 months prior to recruitment to the study 13. In custody 14. Currently participating in other interventional trials 15. Do not live in Wales |
| Date of first enrolment | 30/09/2024 |
| Date of final enrolment | 30/10/2024 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Cardiff
CF14 4XW
United Kingdom
Sponsor information
University/education
Park Place
Cardiff
CF10 3AT
Wales
United Kingdom
| Phone | +44 2920742394 |
|---|---|
| FalconerHE@cardiff.ac.uk | |
| Website | http://www.cardiff.ac.uk/ |
"ROR" |
https://ror.org/03kk7td41 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Health & Care Research Wales, Ymchwil Iechyd a Gofal Cymru, Health Care Research Wales, HCRW
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/11/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Results from the study will be disseminated to the participants in the form of a letter. Public engagement events will be used to disseminate results. Online platforms and Communication channels will be used to share results. Results will be presented at scientific conferences and published in peer-reviewed journals. |
| IPD sharing plan | Anonymised datasets generated and analysed during the study will be available upon request from Dr Lucy Jones JonesL147@cardiff.ac.uk following publication. |
Editorial Notes
28/02/2025: Sponsor details updated.
06/11/2024: Internal review.
09/08/2024: Trial's existence confirmed by NHS HRA.
