PROTECTIVE-D - a feasibility randomised controlled trial examining the effect of a positive mood intervention and vitamin D supplementation on the immunological responses to influenza vaccination in older adults

Royal, Simon, Ayling, Kieran, Hopkins, Georgina, Fairclough, Lucy C. and Vedhara, Kavita 2026. PROTECTIVE-D - a feasibility randomised controlled trial examining the effect of a positive mood intervention and vitamin D supplementation on the immunological responses to influenza vaccination in older adults. Pilot and Feasibility Studies 10.1186/s40814-026-01881-z

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Abstract

Background The effectiveness of vaccines in protecting against disease wanes with increasing age. There is some evidence that psychological wellness and vitamin D supplementation can increase vaccine effectiveness in older people. This study was designed to pilot the acceptability of, and compliance with, study procedures intended for a future large randomised controlled trial (RCT). The procedures included a positive mood intervention (PMI), the use of vitamin D supplements and self-collection of finger-prick blood samples. Methods Twenty-eight adults aged > 65 years were randomised to one of four conditions: (1) PMI and vitamin D supplements, (2) PMI only, (3) Vitamin D supplements only and (4) Usual care. Blood samples were taken before vaccination with the standard seasonal influenza vaccine and again after 28 days. Vitamin D levels and antibodies to influenza were compared before and after the participants received the allocated intervention. Results Good compliance with study procedures, as measured by participant responses to a Short Message Service (SMS) text or email, suggest methods were acceptable and feasible in this population. Self-collection of finger-prick samples to measure antibody responses was accomplished by 16 out of 26 participants (62%). Conclusions This study demonstrates that a large-scale RCT to evaluate two interventions promoting vaccine effectiveness in older adults is feasible. Simple methods of determining patient-reported outcomes and limiting study visits are acceptable to participants and may reduce costs. The finger-prick capillary sampling procedure requires refinement before wider deployment.

Item Type:	Article
Date Type:	Published Online
Status:	In Press
Schools:	Schools > Psychology
Publisher:	BioMed Central
ISSN:	2055-5784
Date of First Compliant Deposit:	23 July 2026
Date of Acceptance:	5 July 2026
Last Modified:	23 Jul 2026 10:15
URI:	https://orca.cardiff.ac.uk/id/eprint/188437

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