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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Biological: Fluzone

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Recruiting
      • Pulmonary Associates
      • Contact: Sunny Sambhara, MD; Phone Number: 602-258-4951

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	3 months

Collaborators and Investigators

• Sponsor: Banner Health
• Collaborators: Sanofi Pasteur, a Sanofi Company

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): February 1, 2016

Study Registration Dates

• First Submitted: September 28, 2015
• First Submitted That Met QC Criteria: September 29, 2015
• First Posted (Estimate): September 30, 2015

Study Record Updates

• Last Update Posted (Estimate): September 30, 2015
• Last Update Submitted That Met QC Criteria: September 29, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: Flu Vaccine Quad vs Tri