A Phase 4 interventional study of Vaxigrip® in Influenza, sponsored by National University Hospital, Singapore. Completed at 9 sites in Singapore. Open to participants aged 21 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-30.
Sponsored by National University Hospital, Singapore · Phase 4, Interventional, and Prevention
The aim of this study is to characterize the immune profile of frail and healthy aged individuals and investigate their immune responsiveness including the response to influenza vaccine over an 18-month period. The project will include a longitudinal study to define immune signatures and multi-parameter profiles associated with frailty and may lead to the identification of predictive markers of evolution to frailty and Immunosenescence in the elderly.
With better healthcare available and improved accessibility, people are living longer. However, a majority of older persons cannot be considered to be aging well. Approximately 70% of those aged 85 years or older require frequent long hospitalizations because of their increased susceptibility to infections, cancers, dementia, and other age-related health problems, along with overall loss of function and autonomy associated with old age. Previous studies have shown that vaccination against influenza, which significantly reduces all-cause mortality in the elderly (65 years and older), was less immunogenic and effective with age. Frailty, a geriatric syndrome associated with low functional activity, weight loss, exhaustion, disability, decreased resilience to stressors, has been shown to increase risk for adverse outcomes and death. Better understanding the relationship between aging and waning immune responsiveness will enable the development of strategies to improve response to vaccination in the elderly and reduce morbidity and eventually mortality associated with age related complications and outcomes such as infectious diseases or frailty. A comprehensive analysis of the immune phenotype and function after antigenic challenge in older individuals would be a unique approach to understand (i) the potential associations between aging, impaired immune function and transition to frailty, (ii) which components of the immune system are altered with aging (innate vs adaptive immunity) and (iii) if early and/or late immune responses are preferentially altered with aging and frailty.
Exclusion Criteria:
Healthy adult participants aged 21-40 years will be vaccinated with Vaxigrip® influenza vaccine
Drug: Vaxigrip®
Healthy Elderly participants aged 65-90 years will be vaccinated with Vaxigrip® influenza vaccine.
Drug: Vaxigrip®
Healthy Elderly participants aged 65-90 years will be vaccinated with Vaxigrip® influenza vaccine.
Drug: Vaxigrip®
Healthy Elderly participants aged 65-90 years will be vaccinated with Vaxigrip® influenza vaccine.
Drug: Vaxigrip®
To describe the humoral immune response to Vaxigrip (IM) vaccination at Day 0 (baseline) and Day 28 according to the age and frailty status at baseline (i.e. in each study group) for each Influenza strain.
The Immune Responsiveness of Elderly Subjects when Administered Influenza Vaccination as Measured by HAI
Hemagglutination Inhibition (HAI) titer
Time frame: 18-month period
Cellular Immune Response and Inflammatory Profile of elderly subjects when administered influenza vaccination - Flu-Specific T cells
% Flu-specific T cells out of total PBMCs
Time frame: 18 months
Flu-Specific B Cell Response
No. of flu-specific B cells quantified out of 1x105 PBMCs
Time frame: 18 months
Inflammatory Markers
Quantitative (pg/mL analyte, picogram of analyte per milliliter of plasma)
Time frame: 18 months
Clinical Assessments of the elderly subjects - Weight
Quantitative Weight (kg, kilograms)
Time frame: 18 months
Clinical Assessments of the elderly subjects - Height
Quantitative Height (m, meters)
Time frame: 18 months
Clinical Assessments of the elderly subjects - BMI
Quantitative BMI (weight and height will be combined to report in kg/m2)
Time frame: 18 months
Clinical Assessments of the elderly subjects - DXA
Quantitative Dual-Energy X-Ray Absorptiometry (DXA) scan: Standardized Muscle Index (appendicular lean mass / height-squared); T-score based on Bone Mineral Density BMD (appendicular lean mass and height will be combined to report in g/cm2)
Time frame: 18 months
Plan to share: Yes — Publication of the data in peer-reviewed journals
Supporting information: Study protocol
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National University Hospital, Singapore