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临床试验/NCT00457977
NCT00457977已完成3 期

Pneumococcal Vaccine Response in COPD

University of Minnesota32 个研究点 分布在 1 个国家目标入组 181 人开始时间: 2007年3月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (32)

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