NCT02675608

Brief Summary

This study evaluates the effectiveness of the seasonal flu vaccine in adults of different ages and diabetic disease statuses. These studies will help our understanding of how chronic inflammatory diseases impact immunologic function and future research on mitigation strategies.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

January 13, 2017

Status Verified

January 1, 2017

Enrollment Period

1.3 years

First QC Date

January 22, 2016

Last Update Submit

January 12, 2017

Conditions

Inflammation

Keywords

vaccine efficacyinflammationagingType 2 Diabetes Mellitusflu vaccine

Outcome Measures

Primary Outcomes (1)

  • Change in HAI titer from day 0 to day 30 (+/- 4 days)

    Blood samples collected days 0 and 30 will be evaluated and compared for flu antibodies using the standards HAI assay with individual virus strains contained in vaccine.

    30 days (+/- 4 days)

Secondary Outcomes (2)

  • Inflammatory Soluble Factor and Cellular Analysis

    day 0

  • Inflammatory Soluble Factor and Cellular Analysis additional measurements

    day 30 (+/- 4 days)

Study Arms (9)

Year 1 Group 1

They are between 18-65 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; have no history of immunodeficiency or weakened immunologic function; do not have diabetes; and do not have chronic HIV or hepatitis B or C infection.

Biological: Influenza Virus Vaccine

Year 1 Group 2

They are ≥65 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; have no history of immunodeficiency or weakened immunologic function; do not have diabetes; and do not have chronic HIV or hepatitis B or C infection.

Biological: Influenza Virus Vaccine

Year 1 Group 3

They are between 18-65 years of age, are currently diabetic, and meet the criteria listed above for not diabetic subjects in Group 1, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of \> 6.5%).

Biological: Influenza Virus Vaccine

Year 1 Group 4

They are ≥65 years of age, are currently diabetic, and meet the criteria listed above for non-diabetic subjects in Group 2, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of \> 6.5%).

Biological: Influenza Virus Vaccine

Year 1 Group 5

They are between 35-50 years of age, meet the criteria listed above for non-diabetic subjects in Group 1, with the exception of chronic HIV with or without hepatitis B or C infection, and have current medical history of CD4 T-cell counts 300-800.

Biological: Influenza Virus Vaccine

Year 2 Group 1

They are between 18-64 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; do not have diabetes.

Year 2 Group 2

They are ≥65 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; do not have diabetes.

Year 2 Group 3

If they are between 18-64 years of age, are currently diabetic, and meet the criteria listed above for not diabetic subjects in Group 1, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of \> 6.5%).

Year 2 Group 4

If they are ≥65 years of age, are currently diabetic, and meet the criteria listed above for non-diabetic subjects in Group 2, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of \> 6.5%).

Interventions

Influenza Virus VaccineBIOLOGICAL

On the first visit, subjects are vaccinated with the 2015-2016 seasonal flu vaccine.

Also known as: FLUVIRIN® NDC 66521-118-11
Year 1 Group 1Year 1 Group 2Year 1 Group 3Year 1 Group 4Year 1 Group 5

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In Year 1 during the 2015-16 flu season, subjects were recruited from the New Orleans metropolitan area through flyers, radio ads, internet ads, social media, and doctor referrals and vaccinated. These subjects were administered the 2015-16 flu vaccine as part of their study visit. In Year 2 during the 2016-17 flu season, subjects were recruited from populations immediately prior or following receiving the flu vaccine at vaccination events, including senior living facilities contracted with the CTU and Tulane University vaccination events for faculty, staff, students.

You may qualify if:

  • Group 1: Must be 18-64 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; have no history of immunodeficiency or weakened immunologic function; do not have diabetes; and do not have chronic HIV or hepatitis B or C infection.
  • Group 2: Must be ≥65 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; have no history of immunodeficiency or weakened immunologic function; do not have diabetes; and do not have chronic HIV or hepatitis B or C infection.
  • Group 3: Must be between 18-64 years of age, are currently diabetic, and meet the criteria listed above for not diabetic subjects in Group 1, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of \> 6.5%).
  • Group 4: Must be ≥65 years of age, are currently diabetic, and meet the criteria listed above for non-diabetic subjects in Group 2, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of \> 6.5%).
  • Group 5: Must be between 35-50 years of age, meet the criteria listed above for non-diabetic subjects in Group 1, with the exception of chronic HIV with or without hepatitis B or C infection, and have current medical history of CD4 T-cell counts 300-800.

You may not qualify if:

  • a history of sensitivity to any of the vaccine components or to influenza vaccine
  • a history of Guillain-Barré syndrome
  • a history of a bleeding disorder or received anticoagulants within the last 3 weeks
  • received the influenza vaccine in the past 6 months or any other vaccines within the last 3 months
  • received immunosuppressive therapy within the last 6 months
  • received long-term systemic corticosteroid therapy for more than 2 consecutive weeks within 3 months
  • received blood or blood-derived products within the last 3 months
  • a daily aspirin intake of \>81mg
  • a blood pressure \>150/95 at screening
  • Group 1: They are between 18-64 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; do not have diabetes.
  • Group 2: They are ≥65 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; do not have diabetes.
  • Group 3: If they are between 18-64 years of age, are currently diabetic, and meet the criteria listed above for not diabetic subjects in Group 1, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of \> 6.5%).
  • NOTE: Current diabetes is defined by patient report of physician diagnosis. Subjects with a history of diabetes which has resolved and no longer requires therapy are not considered to have current diabetes, e.g, women with a history of gestational diabetes, steroid-induced or medication-induced.
  • Group 4: If they are ≥65 years of age, are currently diabetic, and meet the criteria listed above for non-diabetic subjects in Group 2, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of \> 6.5%).
  • Year 2 Subjects will be excluded if they have any of the following:
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tulane Clinical Translational Unit

New Orleans, Louisiana, 70112, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma, serum, PBMCs, urine, saliva

MeSH Terms

Conditions

InflammationDiabetes Mellitus, Type 2Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRespiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Elizabeth B Norton, MPH, PhD

    Tulane University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 22, 2016

First Posted

February 5, 2016

Study Start

August 1, 2015

Primary Completion

December 1, 2016

Last Updated

January 13, 2017

Record last verified: 2017-01

Locations

US(1)