IRFLUVA–Improving the long term immune response to the flu vaccine
Research type
Research Study
Full title
IRFLUVA–Improving the long term immune response to the flu vaccine
IRAS ID
314310
Contact name
Lucy Jones
Contact email
Sponsor organisation
Cardiff University
Duration of Study in the UK
1 years, 2 months, 29 days
Research summary
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, SpermidineLife (SPDLife), can restore and improve levels of Spermidine (SPD) intake in older people. Older people have low levels due to reduced dietary intake. SPD 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 SPD dietary intake. A double-blinded, randomised study we conducted showed that SPD 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 SPDLife 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 SPDLife 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 SPDLife 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 SPDLife 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.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
24/WM/0065
Date of REC Opinion
3 May 2024
REC opinion
Further Information Favourable Opinion