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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02563184
• Other study ID #: Flu Vaccine Quad vs Tri
• Status: Recruiting
• Phase: Phase 4
• First received: September 28, 2015
• Last updated: September 29, 2015
• Start date: September 2015
• Est. completion date: February 2016

Study information

• Verified date: September 2015
• Source: Banner Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Biological:
• Fluzone

Locations

Country	Name	City	State
United States	Pulmonary Associates	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Banner Health	Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No