Evaluation of Metabolic Predictors of Influenza Vaccine Immune Response in the Singapore Elderly Population - the DYNAMIC Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03399357|
Recruitment Status : Recruiting
First Posted : January 16, 2018
Last Update Posted : January 16, 2018
|Condition or disease||Intervention/treatment|
|Influenza Vaccine Immune Response Elderly Vitamin D Deficiency Metabolic Disease Diabetes Mellitus||Biological: Influenza Vaccine|
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.
|Study Type :||Observational|
|Estimated Enrollment :||240 participants|
|Official Title:||Evaluation of Metabolic Predictors of Influenza Vaccine Immune Response in the Singapore Elderly Population- the DYNAMIC Trial|
|Actual Study Start Date :||May 31, 2017|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||February 28, 2019|
≥ 65 Years old
Healthy community-dwelling elderly (men and women) age 65 and above who are eligible for influenza vaccine and fulfil inclusion and exclusion criteria
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
Other Name: Influvac(R) SH 2017
- Humoral immune response measure [ Time Frame: Day 0 to Day 28 post vaccination ]Haemagglutination inhibition (HAI) titer for each of the three influenza vaccine strains in response to influenza vaccine at day 28 compared to baseline (pre-vaccination) titer
Biospecimen Retention: Samples With DNA
Blood samples at "baseline" i.e. Day 0 to D -7 from Vaccination Day (designated as Day 0) and Day 28 +/- 3 post-vaccination to assess HAI (hemagglutinin inhibition) response.
PBMCs to be stored for future studies.
- Baseline blood sample to be tested for 25-OH D assay.
- Stool samples (optional part of study) to be studied for stool microbiome and relation to immune response and Vitamin D status.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399357
|Contact: Sapna P. Sadarangani, MBBS||88091301 ext 63577442||Sapna_Sadarangani@ttsh.com.sg|
|Tan Tock Seng Hospital||Recruiting|
|Singapore, Singapore, 308433|
|Contact: Sapna P. Sadarangani, MBBS 88091031 ext 63577442 Sapna_Sadarangani@ttsh.com.sg|
|Contact: Mei Xuan Tan +65-85229946 ext 64783062 Mei_Xuan_Tan@ttsh.com.sg|
|Principal Investigator: Sapna P Sadarangani, MBBS|
|Sub-Investigator: Barnaby Young, MB BChir, MSc|
|Sub-Investigator: Rinkoo Dalan, MBBS|
|Sub-Investigator: Ezlyn Izzharudin, MBBS|
|Sub-Investigator: Anis Larbi, PhD|