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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02563184
Other study ID # Flu Vaccine Quad vs Tri
Secondary ID
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


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
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