Diabetes Mellitus Clinical Trial
Official title:
Evaluation of Metabolic Predictors of Influenza Vaccine Immune Response in the Singapore Elderly Population- the DYNAMIC Trial
The trial aims to evaluate role of metabolic factors including systemic 25-OH D and diabetes in the adaptive immune response (haemagluttination inhibition titer) to influenza vaccine in the elderly. The influenza vaccine administered in this study will be licensed trivalent inactivated influenza vaccine. Elderly who are age above 65 including those with co-morbidities such as diabetes mellitus will be included. The study has its inclusion and exclusion criteria to determine eligibility for participation.
Novel, effective influenza vaccination strategies are needed in the elderly who have the
highest rate of influenza-related morbidity and mortality. Vaccine efficacy in the elderly is
reduced due to immunosenescence and/or, inflamm-aging. This phase IV clinical trial in 240
participants aims to evaluate metabolic predictors of influenza-vaccine specific immune
response in a multi-ethnic elderly community cohort in Singapore. Specifically, our novel
approach is to evaluate the immunomodulatory roles of vitamin D, diabetes and other metabolic
predictors. This study has translational implications (e.g. using vitamin D as an 'adjuvant',
evaluating biomarkers of vaccine efficacy) to enhance influenza vaccine immunogenicity in the
vulnerable elderly.
Potential benefit: there is a possibility the vaccine may prevent influenza illness or
influenza related complication that might have otherwise occurred. This study will contribute
to body of knowledge of impact of metabolic factors (vitamin D, DM status) on influenza
vaccine immune response, and will be the first study of its kind to be done in an Asian
elderly population. Potential risks related to the blood draw and local/systemic side effects
from influenza vaccine are anticipated to be minimal.
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