Pneumococcal Vaccine Response in COPD
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 32
- 主要终点
- Serotype Opsonization Titers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Serotype Opsonization Titers
时间窗: Measured at Baseline, Months 1, 12, and 24
Opsonophagocytosis activity (OPK) serotype specific geometric means
次要结局
- Serotype-specific Immunoglobulin G (IgG) Antibody Levels(Measured at Baseline, Months 1, 12, and 24)
