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Seasonal Influenza Vaccine, Quadrivalent Versus Trivalent in Patients With Advanced Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fluzone
Sponsored by
Banner Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

50 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Inclusion criteria for patients with COPD will be:

  1. Signed informed consent prior to initiation of study-mandated vaccination.
  2. Patients with spirometric data in the preceding 18 months confirming the diagnosis of COPD.
  3. Patients meeting GOLD Classification of Stage C or Stage D COPD.
  4. Patients 50 years old - 64 years old.

Inclusion criteria for Healthy participants will be:

  1. Signed informed consent prior to initiation of study-mandated vaccination.
  2. No active symptoms of lung disease.
  3. FEV1/FVC in the normal range > 70% age predicted value.
  4. No history of tobacco use/abuse.
  5. No prior history of alpha-1 antitrypsin deficiency.
  6. Patients 50 years old - 64 years old.

Exclusion Criteria:

  1. Severe allergy to eggs.
  2. Severe reaction to past doses of influenza vaccine.
  3. Guillian-Barre syndrome.
  4. Currently recieving dialysis.
  5. Current, active, treatment for cancer.
  6. History of transplant (allograft).
  7. Dementia or Alzheimer's disease diagnosis.
  8. Prior diagnosis of HIV or AIDS.
  9. Moderate to severe pulmonary hypertension.
  10. Serum AST/ALT > 3x the upper limit of normal.
  11. Patients with exacerbations or respiratory infection during the 4 weeks preceding the onset of the study.
  12. Active pregnancy.
  13. Systemic immunomodulating medications.

Sites / Locations

  • Pulmonary AssociatesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

COPD

Control

Arm Description

Group will receive either the Fluzone Trivalent or Fluzone Quadrivalent.

Group will receive either the Fluzone Trivalent or Fluzone Quadrivalent.

Outcomes

Primary Outcome Measures

Hemagglutination inhibiting antibodies (HI) against the components of viral antigens
The investigators will be measuring hemagglutination inhibiting antibodies (HI) against the components of viral antigens using seroconversion (≥4 fold increase over baseline titers) and sero-protection (HI titer of ≥40 against the vaccine components)

Secondary Outcome Measures

Full Information

First Posted
September 28, 2015
Last Updated
September 29, 2015
Sponsor
Banner Health
Collaborators
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT02563184
Brief Title
Seasonal Influenza Vaccine, Quadrivalent Versus Trivalent in Patients With Advanced Chronic Obstructive Pulmonary Disease
Official Title
Seasonal Influenza Vaccine, Quadrivalent Versus Trivalent in Patients With Advanced Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Banner Health
Collaborators
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the magnitude of the humoral immune responses to quadrivalent vs trivalent influenza vaccines in adults between the age of 50 and 64 years with a prior diagnosis of GOLD Stage C and D COPD vs. those patients without COPD.
Detailed Description
Primary Objectives: To evaluate the magnitude of the humoral immune responses to quadrivalent vs trivalent influenza vaccines in adults between the age of 50 and 64 years with a prior diagnosis of GOLD Stage C and D COPD (vs. those patients without COPD). To demonstrate immunogenicity by measuring hemagglutination inhibiting antibodies (HI) against the components of viral antigens using seroconversion (≥4 fold increase over baseline titers) and sero-protection (HI titer of ≥40 against the vaccine components). Secondary Objective: To assess the degree of antibody response of COPD patients based on severity of disease as measured by FEV1. To assess the impact of inhaled corticosteroids on the adaptive immune response after vaccination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COPD
Arm Type
Active Comparator
Arm Description
Group will receive either the Fluzone Trivalent or Fluzone Quadrivalent.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Group will receive either the Fluzone Trivalent or Fluzone Quadrivalent.
Intervention Type
Biological
Intervention Name(s)
Fluzone
Primary Outcome Measure Information:
Title
Hemagglutination inhibiting antibodies (HI) against the components of viral antigens
Description
The investigators will be measuring hemagglutination inhibiting antibodies (HI) against the components of viral antigens using seroconversion (≥4 fold increase over baseline titers) and sero-protection (HI titer of ≥40 against the vaccine components)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inclusion criteria for patients with COPD will be: Signed informed consent prior to initiation of study-mandated vaccination. Patients with spirometric data in the preceding 18 months confirming the diagnosis of COPD. Patients meeting GOLD Classification of Stage C or Stage D COPD. Patients 50 years old - 64 years old. Inclusion criteria for Healthy participants will be: Signed informed consent prior to initiation of study-mandated vaccination. No active symptoms of lung disease. FEV1/FVC in the normal range > 70% age predicted value. No history of tobacco use/abuse. No prior history of alpha-1 antitrypsin deficiency. Patients 50 years old - 64 years old. Exclusion Criteria: Severe allergy to eggs. Severe reaction to past doses of influenza vaccine. Guillian-Barre syndrome. Currently recieving dialysis. Current, active, treatment for cancer. History of transplant (allograft). Dementia or Alzheimer's disease diagnosis. Prior diagnosis of HIV or AIDS. Moderate to severe pulmonary hypertension. Serum AST/ALT > 3x the upper limit of normal. Patients with exacerbations or respiratory infection during the 4 weeks preceding the onset of the study. Active pregnancy. Systemic immunomodulating medications.
Facility Information:
Facility Name
Pulmonary Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunny Sambhara, MD
Phone
602-258-4951

12. IPD Sharing Statement

Learn more about this trial

Seasonal Influenza Vaccine, Quadrivalent Versus Trivalent in Patients With Advanced Chronic Obstructive Pulmonary Disease

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