Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Pneumococcal Vaccine Response in COPD
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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