PROTECTIVE-D: imPROving the effecTivenEss of vaccinaTion wIth positive mood and Vitamin D

• Register: ISRCTN
• Last refreshed on: 18 March 2024
• Main ID: ISRCTN12950625
• Date of registration: 08/02/2024
• Prospective Registration: No
• Primary sponsor: University of Nottingham
• Public title: PROTECTIVE-D: imPROving the effecTivenEss of vaccinaTion wIth positive mood and Vitamin D
• Scientific 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
• Date of first enrolment: 01/02/2023
• Target sample size: 28
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN12950625
• Study type: Interventional
• Study design: Single-centre randomized interventional feasibility study (Treatment)
• Phase: Not Applicable

Countries of recruitment

England, United Kingdom

Contacts

• Name: Simon Royal

• Name: Simon Royal

Key inclusion & exclusion criteria

Inclusion criteria: 1. Able and willing to provide written informed consent to participate in the study
2. Able and willing (in the investigator’s opinion) to comply with all the study requirements
3. Consent to allow investigators to discuss their medical information with their general practitioner and access medical records where relevant to the study
4. Eligible to receive a COVID-19 vaccination and/or influenza vaccination as part of usual care
Exclusion criteria: 1. Enrolled on a COVID-19 vaccine clinical trial of an investigational medicinal product (CTIMP) in the last 12 months
2. Clinically extremely vulnerable and received a third or fourth dose in Spring 2022
3. Aged less than 65 years old
4. Ineligible to receive a COVID-19 and/or influenza vaccination as part of usual care or those for whom a COVID-19 and/or influenza vaccination is contraindicated
5. Collection of blood samples is contraindicated
6. Deemed by health care provider to be:
6.1. Too physically frail to participate.
6.2. Diagnosed with dementia or other cognitive condition which would make participation difficult
6.3. Insufficient command of the English language to complete surveys and provide informed consent
6.4. Participants who, in the past 3 months, have been prescribed oral vitamin D supplementation by a health care professional or who take over-the-counter supplements regularly on the advice of a health care professional


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Vitamin D supplementation and/or positive mood intervention after vaccination
Infections and Infestations

Intervention(s)

This is a feasibility study to identify compliance and adherence to vitamin D for 28 days from the day of vaccination and a positive mood intervention for 7 days from the day of vaccination.

Patients aged 65 years or greater being targeted for COVID-19 and/or influenza vaccination will be recruited from primary care to participate in this feasibility trial. SMS text messages will be sent to potential participants with the PIS attached, a minimum of 24 hours before their appointment. They will be randomly allocated on a 1:1:1:1 basis using an electronic randomisation system to receive:
* No intervention (Usual Care)
* Positive mood intervention on the day of vaccination and for the following 6 days and vitamin D supplementation on the day of vaccination and once daily for the following 27 days
* Positive mood intervention on the day of vaccination and for the following 6 days
* Single dose oral vitamin D supplementation on the day of vaccination and once daily for the following 27 days

15 ml venous blood samples will be collected to detect antibodies to the vaccine antigens. These will be measured at baseline, 4 weeks and 6 months post-vaccine to assess intervention effects on peak vaccine responses and durability of protection. Participants will also receive a daily text message reminder with a link to the positive mood intervention and/or to take their vitamin D supplement, alongside an e-diary link to complete.

A sub-sample of around 20 patients will be invited to have blood samples collected to explore potential cellular and humoral mechanisms at day 0 and day 28. This will entail an additional maximum 60ml blood sample on each occasion.

Interviews will be conducted with patients and health care professionals involved in the pilot trial to identify bar

Primary Outcome(s)

Compliance with study procedures measured using an e-diary from day 1 to day 28
Adherence to study procedures measured using an e-diary from day 1 to day 28

Secondary Outcome(s)

Vaccine-induced influenza antibody titres measured using an ELISA test at baseline and day 28

Secondary ID(s)

Nil known

IRAS 316876, CPMS 54065

Source(s) of Monetary Support

NIHR Clinical Research Network East Midlands

Ethics review

Status: Approved
Approval date: 28/11/2022
Contact:

[e-mail]

London - Harrow Research Ethics Committee; ref: 22/LO/0714

[phone]

[e-mail]

Results

• Results available: Yes
• Date Completed: 01/04/2023