Comparing Two Pneumococcal Vaccines in Adults With Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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Pneumococcal disease is a serious bacterial infection that can affect different parts of the body, including the lungs. People with chronic illnesses, such as chronic obstructive pulmonary disease (COPD), have a greater risk of developing pneumonia and meningitis as a result of pneumococcal disease. This study will compare the immune response to two types of pneumococcal vaccines in adults with COPD.

Detailed Description
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Individuals who are infected with the Streptococcus pneumoniae bacteria may develop pneumococcal disease, a serious disease that kills more people in the United States than all other vaccine-preventable diseases combined. Individuals with COPD, characterized by breathing difficulties due to damaged and obstructed lung airways, may have an increased risk of developing serious complications from pneumococcal disease, including pneumonia and meningitis. Currently, there are two types of pneumococcal vaccines available. The pneumococcal capsular polysaccharide (CPS) vaccine, known as Pneumovax, is typically given to adults 65 years of age or older and to any individuals with a serious health condition, including heart disease, lung disease, and diabetes. The diphtheria protein-conjugated vaccine (PCV7), known as Prevnar, is typically given to infants; however, adults who receive this vaccine may also have a favorable response. The purpose of this study is to compare the immune response to the Pneumovax and Prevnar vaccines in adults with COPD. This study will enroll adults with mild to moderate COPD. Participants will be randomly assigned to receive either the Pneumovax or Prevnar vaccine. This will involve one or two injections. Blood collection will occur during study visits at Months 1, 12, and 24. Study researchers will contact participants by telephone at Months 6 and 18 to document any pneumococcal infections and any additional pneumococcal vaccinations.

Official Title
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Pneumococcal Vaccine Response in COPD

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Biological: Pneumovax (PPSV23)
* Biological: Prevnar (PCV7)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Post-bronchodilator forced expiratory volume at one second /forced vital capacity (FEV1/FVC) level less than 70% Ten or more pack-years of smoking Willing to make return visits to the study clinic and accept telephone contact Last pneumococcal vaccination occured at least 5 years prior to study entry Exclusion Criteria: Asthma Sensitivity to pneumococcal vaccine Known bleeding disorder, or requires long-term anticoagulation therapy Presence of chronic disease that may impair pneumococcal vaccine response Acute illness requiring antibiotics in the month prior to study entry Medical condition that makes survival for 24 months following study entry unlikely Pregnant

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pneumovax (PPSV23)<br>pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax) | Biological: Pneumovax (PPSV23)<br>* Injection<br>* Other names: Pneumovax;|
| Active Comparator: Prevnar (PCV7)<br>diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose | Biological: Prevnar (PCV7)<br>* Injection<br>* Other names: Prevnar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serotype Opsonization Titers | Opsonophagocytosis activity (OPK) serotype specific geometric means | Measured at Baseline, Months 1, 12, and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype-specific immunoglobulin G Geometric Mean IgG antibody levels (ug/ml) | Measured at Baseline, Months 1, 12, and 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease, COPD, Pneumococcal, Vaccine, Opsonization, Antibodies