PROTECTIVE-D
Research type
Research Study
Full title
A feasibility randomised controlled trial examining the effect of a positive mood intervention and vitamin D supplementation on the immunological responses to a boosting COVID-19 and/or influenza vaccination in healthy adults
IRAS ID
316876
Contact name
Stephanie Pearson
Contact email
Sponsor organisation
The University of Nottingham Health Service
ISRCTN Number
ISRCTN12950625
Duration of Study in the UK
0 years, 5 months, 1 days
Research summary
Vaccines help us prevent diseases and keep us well. Some vaccines work better than others and there are many reasons for this. It can be to do with the vaccine itself or to do with the person having the vaccine. We have already found that people who report feeling happier on the day they are vaccinated produce more antibodies in response to the vaccination. We have also found that giving people only 15 minutes of a positive mood intervention to watch before they are vaccinated improves their mood. Recent research also suggests that the amount of vitamin D in your body at the time of vaccination can affect how well vaccines work.
In this study we will conduct a small experiment in which people who are about to receive a COVID-19 and/or influenza vaccination will be put in one of 4 groups at random.
Group 1 will not be offered anything other than their vaccine (this is called usual care).
Group 2 will receive a brief positive mood intervention, which has previously been shown to improve positive mood on the day they are vaccinated and for a further 6 days. They will also be advised to take a single dose of a vitamin D tablet just before they are vaccinated and once daily for the following 27 days.
Group 3 will also receive the positive mood intervention on the day they are vaccinated and for a further 6 days but they will not take the vitamin D tablet.
Group 4 will be advised to take a vitamin D tablet at the time of vaccination and once daily for the following 27 days.
We will ask all participants to provide 15ml blood samples at baseline, 28 days and at 6 months post vaccination. This sample will help us measure antibody responses to the vaccination and determine how well people have responded. In addition, around 20 people across all groups will be asked to provide up to a 60ml blood sample at baseline and at day 28. These samples will allow us to understand how our interventions are changing the way the immune system works.
Finally, we will also interview a small number of participants as well as people working in primary care to gain their views on our approach to improving vaccine effectiveness. This work will help to identify if there is an easy and effective way to make vaccines work better that is acceptable to doctors and patients, doesn’t have any side effects and which anyone, anywhere can try.
REC name
London - Harrow Research Ethics Committee
REC reference
22/LO/0714
Date of REC Opinion
18 Nov 2022
REC opinion
Further Information Favourable Opinion