Influenza VaccineNCT03399357
Evaluation of Metabolic Predictors of Influenza Vaccine Immune Response in the Singapore Elderly Population - the DYNAMIC Trial
An observational study of Influenza Vaccine and Immune Response, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Vaccine, Immune Response, Elderly
- What is being tested?
- Influenza Vaccine
- Type of treatment
- Vaccines
- How many people
- 240 participants
- Where
- 1 siteSingapore
- Study dates
- 31 May 2017to 28 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Tan Tock Seng Hospital
Singapore, 308433
Sapna P. Sadarangani, MBBS, 88091031 ext. 63577442, Sapna_Sadarangani@ttsh.com.sg
Mei Xuan Tan, +65-85229946 ext. 64783062, Mei_Xuan_Tan@ttsh.com.sg
About this study
Official title: Evaluation of Metabolic Predictors of Influenza Vaccine Immune Response in the Singapore Elderly Population- the DYNAMIC Trial
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.
Read the 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
- Being tested
- Influenza Vaccine
- Medical subject headings
- Influenza, Human, Vitamin D Deficiency, Metabolic Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza VaccineBiological
Also called Influvac(R) SH 2017
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
| Study group | Role | What they receive |
|---|---|---|
| ≥ 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 Receives: Biological: Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0 to Day 28 post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start31 May 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore Immunology Network, National Healthcare Group, Singapore
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399357
- Sponsor's protocol ID
- DSRB 2016/00248
- Status last verified
- Jan 2018
- First submitted
- 8 Jan 2018
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Metabolic Predictors of Influenza Vaccine Immune Response in the Singapore Elderly Population- the DYNAMIC Trial
- ClinicalTrials.gov ID
- NCT03399357
- Acronym / sponsor ID
- DSRB 2016/00248
- Conditions
- Influenza Vaccine, Immune Response, Elderly, Vitamin D Deficiency, Metabolic Disease, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- Singapore Immunology Network, National Healthcare Group, Singapore
- Study start
- 31 May 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 16 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ≥ 65 Years old | – | Biological: Influenza VaccineHealthy community-dwelling elderly (men and women) age 65 and above who are eligible for influenza vaccine and fulfil inclusion and exclusion criteria |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza VaccineAlso: Influvac(R) SH 2017Inactivated 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 | Biological | ≥ 65 Years old |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza Vaccine and Immune Response, run by Tan Tock Seng Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sapna P. Sadarangani, MBBS (88091301 ext. 63577442, Sapna_Sadarangani@ttsh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Humoral immune response measure (time frame: Day 0 to Day 28 post vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.