Impact of Metabolic Syndrome on Flu Vaccine Efficacy

Stopped early · Not applicable

Conditions studied: Immune Deficiency, Metabolic Syndrome

In brief

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.

Key facts

Study ID

NCT02653495

Run by

Rockefeller University

People needed

17

Starts

2016-01-01

Expected to finish

2017-03-01

Last updated by the study team

2017-09-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• 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
• 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.

Where it is running

• Rockefeller University — New York, New York, United States

Full record on ClinicalTrials.gov

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