Impact of Metabolic Syndrome on Flu Vaccine Efficacy

NCT02653495 | Terminated Results

• 1 other identifier: UAN-0891
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Immune Deficiency; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Antibody Response D28

  Measured by hemagglutination inhibition assay

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

Secondary Outcomes (4)

• Gene Expression Profiling D1

  1 day post-vaccination compare to baseline (gene expression screening visit #1 and study visit #1 D0 of vaccination)

• Gene Expression Profiling D28

  28 days post-vaccination compare to baseline (gene expression screening visit #1 and study visit #1 D0 of vaccination)

• Gene Expression Profiling D90

  90 days post-vaccination compare to baseline (gene expression screening visit #1 and study visit #1 D0 of vaccination)

• Antibody Response D90

  90 days after vaccination compare to day 28

Study Arms (2)

Influenza vaccine in metabolic syndrome

EXPERIMENTAL

Influenza vaccine

Biological: Influenza vaccine

Influenza vaccine in healthy controls

EXPERIMENTAL

Influenza vaccine

Biological: Influenza vaccine

Interventions

Influenza vaccine BIOLOGICAL

Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3

Influenza vaccine in healthy controls; Influenza vaccine in metabolic syndrome

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Abdominal Obesity, given as a waist circumference: Men \>102 cm (\>40 in) Women \> 88 cm (\>35 in)
• Triglycerides \>150 mg/dl
• HDL Cholesterol: Men \< 40 mg/dl Women \< 50 mg/dl
• Blood Pressure \>130/ \>85 mm Hg - or controlled on antihypertensive medication
• Fasting Glucose \> 100 mg/dl
• body mass index 18.5 - 25 kg/m2
• HDL female \> 50 mg/dL, male \> 40 mg/dL
• fasting glucose \< 100 mg/dL
• triglycerides \<150 mg/dL,
• waist circumference of a female \< 88 cm, male \< 102 cm)
• \- Blood pressure \< or = to 120/80 (based on an average of 3 readings taken 5 minutes apart after the consent form has been signed)

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.

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

Rockefeller University

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Immunologic Deficiency Syndromes; Metabolic Syndrome

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Immune System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Limitations and Caveats

Inclusion Criteria hard to meet among population: many individuals do not self-identify as having metabolic syndrome, participants must have untreated metabolic syndrome. Challenges led to early termination with sample size not being attainable.

Results Point of Contact

• Title: Dr. Ursula Andreo
• Organization: Rockefeller University

uandreo@gmail.com

212-327-7894

Study Officials

• Ursula Andreo, PhD

  The Rockefeller University Center for Clinical and Translational

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 12, 2016
• Study Start: January 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: September 28, 2017
• Results First Posted: September 28, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)