Immune DeficiencyNCT02653495
Impact of Metabolic Syndrome on Flu Vaccine Efficacy
A study testing Influenza vaccine in people with Immune Deficiency and Metabolic Syndrome, run by Rockefeller University at 1 site in United States.
Trial summary
Metabolic syndrome (MetS) is a cluster of metabolic conditions associated with obesity that predispose individuals to coronary heart diseases and diabetes but obesity has been shown to increase the risks of other diseases like cancer and asthma. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Deficiency, Metabolic Syndrome
- What is being tested?
- Influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Currently undergoing treatment for the metabolic syndrome
- The average of 2 BP readings > 150/90 (based on 2 B/Ps taken at screening visit 1).
- Hepatitis A, B and C
- NSAIDs and/or Aspirin ingestion within the last 14 days
- Self-reported history of any active autoimmune diseases
- Self-reported ingestion of statins within the last 3 months
Show all 17Show fewer
- Self-reported antibiotic use within the last 3 months
- Anti-inflammatory drugs including biologics and corticosteroids within last 3 months( nasal spray and topical applications are OK)or Omega 3 Fatty Acids.
- Self-reported hx of cancer treatment within the last year
- Allergy to eggs
- History of Guillain-Barre syndrome
- Pregnant ( determined by point of care testing at screening visit 1).
- HIV positive
- Self-reported history of flu vaccination within the past 3 months.
- Any self-reported infection in the week of the visit except the first two visits (Screening visit 1 and Screening visit 2) and the last visit (Study visit #5) that could be rescheduled.
- Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data.
- Study Population Description The population from which the groups will be selected are resident of New York City.
Trial locations and contacts
1 site in 1 country.
About this study
Metabolic syndrome (MetS) is a cluster of metabolic conditions associated with obesity that predispose individuals to coronary heart diseases and diabetes but obesity has been shown to increase the risks of other diseases like cancer and asthma. Studies have also shown that obesity increases the risk of severe influenza infection and associated death and reduces the efficacy of influenza vaccine in the obese population but yet, the molecular mechanisms have not been described. The investigators are thus hypothesizing that differences in the innate immune responses between individual with or without metabolic syndrome impact viral infection and vaccine outcome. The investigators will perform seasonal influenza vaccination in people with or without metabolic syndrome to determine if the late adaptive response assessed by antibodies titers is different between the two groups and correlates with the early immune response assessed by gene expression profile in whole blood cells. The project proposed by the investigators will contribute to a better understanding of the inflammatory phenotype associated with metabolic syndrome and establish for the first time if it affects the immune protection against infectious diseases and particularly against influenza virus infection. The results will be important to determine if the population affected by metabolic syndrome should receive anti-influenza treatment in priority in the context of a severe influenza epidemic.
Read the detailed description
The development of industrialization with increased food consumption and sedentarity has given rise to an obesity pandemic, which affects up to 30% of the population in countries like US, these populations being at greater risk for cardiovascular diseases, and diabetes. More than obesity per se, visceral obesity is associated with metabolic diseases that cluster together and clinically defined metabolic syndrome. MetS comprises individuals with at least three of the 5 of the following factors: abdominal obesity, high blood triglycerides, low HDL ("good cholesterol"), high blood pressure and elevated fasting glucose. Metabolic syndrome is associated with a low-grade inflammation characterized by an infiltration of immune cells particularly in the adipose tissue, the liver and the pancreas that is thought to be responsible for the induction of insulin resistance. It is thought that obesity predisposes to other diseases such as cancer, asthma but only little attention has been given to infectious diseases. Studies have shown that obesity increases the risk of severe influenza infection and associated death and reduces the efficacy of influenza vaccine in the obese population but yet, the molecular mechanisms have not been described. Immune dysfunctions associated with obesity are suspected to play a major role but obesity is often associated with respiratory disorders that could directly explain the increased susceptibility to influenza infection. Also, metabolically healthy obesity is less associated with inflammation. Therefore, the investigators would like to focus particularly on metabolic syndrome, and determine how it influences immune response to viruses.
The investigators are thus hypothesizing that differences in the innate immune responses between individual with or without metabolic syndrome impact viral infection and vaccine outcome. Recent studies involving complex biological analysis and computational modeling have shown that the ability of an individual to positively respond to influenza vaccine can be molecularly predicted by looking at markers in the blood cells. The investigators will perform seasonal influenza vaccination in people with or without metabolic syndrome to determine if the late adaptive response assessed by antibodies titers is different between the two groups and correlates with the early immune response assessed by gene expression profile in whole blood cells.
Healthy nutritional habits along with increased physical activities should be best at preventing the development of metabolic syndrome but socio-economical issues are slowing the implementation of these changes. Therefore, as metabolic syndrome is raising public health concerns, it is important to understand why the metabolic syndrome affects susceptibility to diseases.
- Conditions
- Immune Deficiency, Metabolic Syndrome
- Being tested
- Influenza vaccine
- Medical subject headings
- Immunologic Deficiency Syndromes, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza vaccineBiological
Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3
| Study group | Role | What they receive |
|---|---|---|
| Influenza vaccine in metabolic syndrome | Experimental | Influenza vaccine Receives: Biological: Influenza vaccine |
| Influenza vaccine in healthy controls | Experimental | Influenza vaccine Receives: Biological: Influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody Response D28
Measured by hemagglutination inhibition assay
Measured: 28 days after vaccination compare to baseline (screening visit 1) pre-vaccination
Secondary outcomes (4)
Gene Expression Profiling D1
Analyze by RNA-seq
Measured: 1 day post-vaccination compare to baseline (gene expression screening visit #1 and study visit #1 D0 of vaccination)
Gene Expression Profiling D28
Analyze by RNA-seq
Measured: 28 days post-vaccination compare to baseline (gene expression screening visit #1 and study visit #1 D0 of vaccination)
Gene Expression Profiling D90
Analyze by RNA-seq
Measured: 90 days post-vaccination compare to baseline (gene expression screening visit #1 and study visit #1 D0 of vaccination)
Antibody Response D90
Measured by hemagglutination inhibition assay
Measured: 90 days after vaccination compare to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2017
- Study completionMar 2017
Why it stopped: Target accrual not met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Immune DeficiencyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ursula Andreo, PhD, Principal investigator, The Rockefeller University Center for Clinical and Translational
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653495
- Sponsor's protocol ID
- UAN-0891
- Status last verified
- Sep 2017
- First submitted
- 8 Jan 2016
- Last updated
- 28 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Metabolic Syndrome on Flu Vaccine Efficacy
- ClinicalTrials.gov ID
- NCT02653495
- Acronym / sponsor ID
- UAN-0891
- Conditions
- Immune Deficiency, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Target accrual not met
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Posted 28 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Metabolic syndrome (MetS) is a cluster of metabolic conditions associated with obesity that predispose individuals to coronary heart diseases and diabetes but obesity has been shown to increase the risks of other diseases like cancer and asthma. Studies have also shown that obesity increases the risk of severe influenza infection and associated death and reduces the efficacy of influenza vaccine in the obese population but yet, the molecular mechanisms have not been described. The investigators are thus hypothesizing that differences in the innate immune responses between individual with or without metabolic syndrome impact viral infection and vaccine outcome. The investigators will perform seasonal influenza vaccination in people with or without metabolic syndrome to determine if the late adaptive response assessed by antibodies titers is different between the two groups and correlates with the early immune response assessed by gene expression profile in whole blood cells. The project proposed by the investigators will contribute to a better understanding of the inflammatory phenotype associated with metabolic syndrome and establish for the first time if it affects the immune protection against infectious diseases and particularly against influenza virus infection. The results will be important to determine if the population affected by metabolic syndrome should receive anti-influenza treatment in priority in the context of a severe influenza epidemic.
Detailed description
The development of industrialization with increased food consumption and sedentarity has given rise to an obesity pandemic, which affects up to 30% of the population in countries like US, these populations being at greater risk for cardiovascular diseases, and diabetes. More than obesity per se, visceral obesity is associated with metabolic diseases that cluster together and clinically defined metabolic syndrome. MetS comprises individuals with at least three of the 5 of the following factors: abdominal obesity, high blood triglycerides, low HDL ("good cholesterol"), high blood pressure and elevated fasting glucose. Metabolic syndrome is associated with a low-grade inflammation characterized by an infiltration of immune cells particularly in the adipose tissue, the liver and the pancreas that is thought to be responsible for the induction of insulin resistance. It is thought that obesity predisposes to other diseases such as cancer, asthma but only little attention has been given to infectious diseases. Studies have shown that obesity increases the risk of severe influenza infection and associated death and reduces the efficacy of influenza vaccine in the obese population but yet, the molecular mechanisms have not been described. Immune dysfunctions associated with obesity are suspected to play a major role but obesity is often associated with respiratory disorders that could directly explain the increased susceptibility to influenza infection. Also, metabolically healthy obesity is less associated with inflammation. Therefore, the investigators would like to focus particularly on metabolic syndrome, and determine how it influences immune response to viruses.
The investigators are thus hypothesizing that differences in the innate immune responses between individual with or without metabolic syndrome impact viral infection and vaccine outcome. Recent studies involving complex biological analysis and computational modeling have shown that the ability of an individual to positively respond to influenza vaccine can be molecularly predicted by looking at markers in the blood cells. The investigators will perform seasonal influenza vaccination in people with or without metabolic syndrome to determine if the late adaptive response assessed by antibodies titers is different between the two groups and correlates with the early immune response assessed by gene expression profile in whole blood cells.
Healthy nutritional habits along with increased physical activities should be best at preventing the development of metabolic syndrome but socio-economical issues are slowing the implementation of these changes. Therefore, as metabolic syndrome is raising public health concerns, it is important to understand why the metabolic syndrome affects susceptibility to diseases.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Influenza vaccine in metabolic syndrome | Experimental | Biological: Influenza vaccineInfluenza vaccine |
| Influenza vaccine in healthy controls | Experimental | Biological: Influenza vaccineInfluenza vaccine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- Currently undergoing treatment for the metabolic syndrome
- The average of 2 BP readings > 150/90 (based on 2 B/Ps taken at screening visit 1).
- Hepatitis A, B and C
- NSAIDs and/or Aspirin ingestion within the last 14 days
- Self-reported history of any active autoimmune diseases
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 vaccineInfluenza vaccine administered intramuscularly (IM), 1 time only, on visit 3 | Biological | Influenza vaccine in healthy controls, Influenza vaccine in metabolic syndrome |
Primary outcome
Antibody Response D28
Time frame: 28 days after vaccination compare to baseline (screening visit 1) pre-vaccination
Measured by hemagglutination inhibition assay
4 secondary outcomes
Gene Expression Profiling D1
Time frame: 1 day post-vaccination compare to baseline (gene expression screening visit #1 and study visit #1 D0 of vaccination)
Gene Expression Profiling D28
Time frame: 28 days post-vaccination compare to baseline (gene expression screening visit #1 and study visit #1 D0 of vaccination)
Gene Expression Profiling D90
Time frame: 90 days post-vaccination compare to baseline (gene expression screening visit #1 and study visit #1 D0 of vaccination)
Antibody Response D90
Time frame: 90 days after vaccination compare to day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Ursula Andreo, PhD principal investigator
The Rockefeller University Center for Clinical and Translational
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Influenza vaccine in people with Immune Deficiency and Metabolic Syndrome, run by Rockefeller University at 1 site in United States.
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 0 inclusion and 17 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: stopped early, as of the sponsor's last update on 28 Sep 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 28 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody Response D28 (time frame: 28 days after vaccination compare to baseline (screening visit 1) pre-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 28 Sep 2017; AzTrials last refreshed its copy on 8 Nov 2026.