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

NCT03399357 | Unknown

• 1 other identifier: DSRB 2016/00248
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Humoral immune response measure

  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

  Day 0 to Day 28 post vaccination

Study Arms (1)

≥ 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

Interventions

Influenza Vaccine BIOLOGICAL

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

Also known as: Influvac(R) SH 2017

≥ 65 Years old

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• Singapore Immunology Network: collaborator
• National Healthcare Group, Singapore: collaborator

Study Sites (1)

Tan Tock Seng Hospital

Singapore, 308433, Singapore

RECRUITING

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.

MeSH Terms

Conditions

Influenza, Human; Vitamin D Deficiency; Metabolic Diseases; Diabetes Mellitus

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Central Study Contacts

Sapna P. Sadarangani, MBBS

CONTACT

88091301; Sapna_Sadarangani@ttsh.com.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 16, 2018
• Study Start: May 31, 2017
• Primary Completion: December 31, 2018
• Study Completion: February 28, 2019
• Last Updated: January 16, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)