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

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ClinicalTrials.gov Identifier: NCT03399357
Recruitment Status : Recruiting
First Posted : January 16, 2018
Last Update Posted : January 16, 2018
Sponsor:
Collaborators:
Singapore Immunology Network
National Healthcare Group, Singapore
Information provided by (Responsible Party):
Tan Tock Seng Hospital

Brief 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.

Condition or disease Intervention/treatment
Influenza Vaccine Immune Response Elderly Vitamin D Deficiency Metabolic Disease Diabetes Mellitus Biological: Influenza Vaccine

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.


Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Group/Cohort Intervention/treatment
≥ 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




Primary Outcome Measures :
  1. 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
  1. 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.

  2. Baseline blood sample to be tested for 25-OH D assay.
  3. Stool samples (optional part of study) to be studied for stool microbiome and relation to immune response and Vitamin D status.


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Ages Eligible for Study:   65 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy elderly population with stable comorbidities (in particular diabetes mellitus) is chosen for this study to evaluate metabolic factors and predictors related to immunosenescence, inflamm-aging and immune response to vaccination. Vaccination is one of our key preventive measures for influenza yet additional insight is needed regarding adaptive response in this vulnerable population, to ultimately lead to novel vaccination strategies.
Criteria

Inclusion Criteria:

  • Age 65 and above at time of enrollment (up to age 100) and able to give informed consent
  • Determined by medical history, physical examination, and clinical judgment to be generally healthy, with no immunosuppressive conditions and having stable current medical conditions. Subjects with preexisting, stable disease, defined as not requiring significant change in therapy or hospitalization for worsening of disease 12 weeks prior to receipt of study vaccine are eligible. A change in dose or therapy within a treatment category (e.g., change from one non-steroidal anti-inflammatory drug to another) is allowed. A change to a new therapy category (e.g., surgery or addition of a new pharmacological class) is only allowed if it is not caused by worsening disease.
  • Is eligible for seasonal influenza vaccine
  • Is available for all planned study visits
  • Is willing to follow study procedures
  • Able to follow study procedures (questionnaires, blood draws, vaccination) in the opinion of the investigator

Exclusion Criteria:

  • A change to a new therapy category caused by worsening disease is considered significant and will disqualify subject from participating in the study
  • Subjects reporting any symptoms suggestive of influenza, influenza-like illness, or respiratory illness
  • Vaccination with any licensed or experimental influenza vaccine within the past 10 months
  • Intent to receive any other investigational vaccine or agent during the course of the study
  • Intent to receive other licensed vaccines during the course of the study (does not apply for pandemic or post-exposure prophylaxis scenario
  • History of severe adverse reaction associated with an influenza vaccine
  • Allergic to egg proteins (egg or egg products) and chicken proteins
  • Known or suspected immunodeficiency or receiving treatment with immunosuppressive therapy including cytotoxic agents in past 6 months e.g., transplant recipients on active immunosuppression, patients with cancer, HIV, or autoimmune disease.
  • Long-term systemic corticosteroid therapy (prednisolone ≥ 7.5mg/day or equivalent for more than 2 consecutive weeks within the past 3 months) Note: If systemic corticosteroids have been administered short term for treatment of an acute illness, subjects will be excluded from the study until corticosteroid therapy had been discontinued for at least 30 days.
  • History of Guillain-Barré syndrome
  • Serious chronic medical condition including: metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, CKD stage 3 and above, end stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that in the investigator's opinion should preclude the subject from participating in the study
  • Bariatric surgery, GI malabsorption disorders
  • Recurrent Falls (≥2 falls in the past 12 months)
  • Osteoporosis with or without pathological fractures
  • Current or recently completed high dose vitamin D supplementation within the past 3 months (defined as daily cholecalciferol dose of 2000 IU or higher, weekly 50,000 IU or intramuscular calcitriol)
  • Receipt of any blood products, including immunoglobulin, within six months of study enrollment
  • Donated blood within last 58 days
  • Current anticoagulant therapy or a history of bleeding diathesis (including thrombocytopenia with platelet count < 50,000) that would contraindicate intramuscular (IM) injection (Note: antiplatelet drugs such as aspirin and clopidogrel are permitted)
  • Moderate or severe acute illness/infection (according to investigator judgement) on the day of vaccination, or febrile illness (temperature ≥ 37.5°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
  • Any medical condition that would, in the opinion of the investigator, interfere with the evaluation of the study objectives

Information from the National Library of Medicine

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


Contacts
Contact: Sapna P. Sadarangani, MBBS 88091301 ext 63577442 Sapna_Sadarangani@ttsh.com.sg

Locations
Singapore
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         
Sponsors and Collaborators
Tan Tock Seng Hospital
Singapore Immunology Network
National Healthcare Group, Singapore

Responsible Party: Tan Tock Seng Hospital
ClinicalTrials.gov Identifier: NCT03399357     History of Changes
Other Study ID Numbers: DSRB 2016/00248
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Influenza, Human
Vitamin D Deficiency
Metabolic Diseases
Glucose Metabolism Disorders
Endocrine System Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vaccines
Immunologic Factors
Physiological Effects of Drugs