NCT03399357

Evaluation of Metabolic Predictors of Influenza Vaccine Immune Response in the Singapore Elderly Population - the DYNAMIC Trial

Evaluation of Metabolic Predictors of Influenza Vaccine Immune Response in the Singapore Elderly Population- the DYNAMIC Trial

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 240 (estimated)
• Sponsor: Tan Tock Seng Hospital · Academic / Other
• Sex: All
• Age: 65 Years – 100 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Influenza Vaccine
• Immune Response
• Elderly
• Vitamin D Deficiency
• Metabolic Disease
• Diabetes Mellitus

Interventions

Type	Name	Description
BIOLOGICAL	Influenza Vaccine	Inactivated Trivalent Influenza Vaccine (IIV3) 2017 containing: A (H1N1): an A/Michigan/45/2015 (H1N1) - like virus (new strain); A (H3N2): an A/Hong Kong/4801/2014 (H3N2) - like virus; B/Brisbane/60/2008 - like virus

Timeline

• Start date: 2017-05-31
• Primary completion: 2018-12-31
• Completion: 2019-02-28
• First posted: 2018-01-16
• Last updated: 2018-01-16

Locations

1 site across 1 country: Singapore