Seasonal Influenza Vaccine, Quadrivalent Versus Trivalent in Patients With Advanced Chronic Obstructive Pulmonary Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 50 - 64 |
| Updated: | 4/21/2016 |
| Start Date: | September 2015 |
| End Date: | February 2016 |
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.
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.
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.
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.
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.
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