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

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ClinicalTrials.gov Identifier: NCT02563184
Recruitment Status : Unknown
Verified September 2015 by David Baratz, M.D., Banner Health.
Recruitment status was:  Recruiting
First Posted : September 30, 2015
Last Update Posted : September 30, 2015
Sponsor:
Collaborator:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
David Baratz, M.D., Banner Health

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Biological: Fluzone Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Seasonal Influenza Vaccine, Quadrivalent Versus Trivalent in Patients With Advanced Chronic Obstructive Pulmonary Disease
Study Start Date : September 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: COPD
Group will receive either the Fluzone Trivalent or Fluzone Quadrivalent.
Biological: Fluzone
Active Comparator: Control
Group will receive either the Fluzone Trivalent or Fluzone Quadrivalent.
Biological: Fluzone



Primary Outcome Measures :
  1. Hemagglutination inhibiting antibodies (HI) against the components of viral antigens [ Time Frame: 3 months ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563184


Locations
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United States, Arizona
Pulmonary Associates Recruiting
Phoenix, Arizona, United States, 85006
Contact: Sunny Sambhara, MD    602-258-4951      
Sponsors and Collaborators
Banner Health
Sanofi Pasteur, a Sanofi Company

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Responsible Party: David Baratz, M.D., Medical Doctor, Banner Health
ClinicalTrials.gov Identifier: NCT02563184     History of Changes
Other Study ID Numbers: Flu Vaccine Quad vs Tri
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs