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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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
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.

United States1 site
  • Rockefeller University

    New York, New York, 10065

Other trials in United States

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.

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 groups in NCT02653495
Study groupRoleWhat they receive
Influenza vaccine in metabolic syndromeExperimentalInfluenza vaccine
Receives: Biological: Influenza vaccine
Influenza vaccine in healthy controlsExperimentalInfluenza vaccine
Receives: Biological: Influenza vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Antibody Response D28

    Measured by hemagglutination inhibition assay

    Measured: 28 days after vaccination compare to baseline (screening visit 1) pre-vaccination

Secondary outcomes (4)
  1. 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)

  2. 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)

  3. 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)

  4. 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.

  1. First posted12 Jan 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionMar 2017
  4. Study completionMar 2017

Why it stopped: Target accrual not met

Resources

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)
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
Data monitoring committee
No
Individual data sharing
No

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.

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