Pneumococcal Post-Vaccination Titers
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Change from pre-to post-vaccination antibody titer
研究概览
简要总结
The study is looking at the pneumonia vaccine and the immune system response to this vaccine. The information gathered from this study may be important for your doctor to take care of patients with smoking histories, immune deficiency, asthma, Chronic Obstructive Pulmonary Disease (COPD), or elderly patients. It is important that your immune system builds a strong defense to the vaccine so that you are better able to fight a bacterium that can cause pneumonia. Some disease prevent the immune system from building a strong defense and these patients will not benefit from the vaccine.
详细描述
One hundred forty subjects will have pre-vaccination titers checked for the 23 serotypes in the PPV-23 vaccine. They will then receive the vaccine. All subjects will be given the vaccination as standard of care. Approximately 4 weeks following immunization, the subjects will have post-vaccination titers checked to the same serotypes checked prior to vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent will be administered to individuals from 5 cohorts each with 28 subjects for a total of 140 subjects. The cohorts will be:
- •smokers between the ages of 19-
- •elderly individuals, defined as subjects age 50 years or older, without a history of frequent infections, COPD or asthma.
- •COPD subjects between the age of 19 and 80, without a history of recurrent bacterial infections.
- •Asthmatics between the ages of 19 and 80, without a history of recurrent bacterial infections.
- •individuals between the age of 19 and 80 who have a history of frequent bacterial infections and are being evaluated for humoral immunodeficiency.
排除标准
- •The following groups will be excluded:
- •Subjects who are currently receiving or have ever received immunoglobulin replacement therapy.
- •subjects who are on immune suppressive agents.
- •Subjects who are on chronic steroids or have received an intramuscular injection of steroids in the three months prior to enrollment or oral/intravenous steroids within a month of enrollment or two or more prednisone bursts in the past year.
- •subjects on antiepileptic agents.
- •Subjects who have received the pneumococcal polysaccharide vaccine, PPV-23 6) Pregnant women
研究组 & 干预措施
elderly individuals (over age 50)
elderly individuals, defined as subjects age 50 years or older, without a history of frequent infections, COPD, or asthma
干预措施: PPV-23 (Biological)
COPD subjects
COPD subjects between the age of 19 and 80, without history of recurrent bacterial infections.
干预措施: PPV-23 (Biological)
Asthmatics subjects
Asthmatics between the ages of 19 and 80
干预措施: PPV-23 (Biological)
Subjects with recurrent bacterial infections
Individuals between the age of 19 and 80 who have a history of frequent bacterial infections and are being evaluated for humoral immunodeficiency
干预措施: PPV-23 (Biological)
Smokers between the ages of 19-80
current smokers between the ages of 19 and 80
干预措施: PPV-23 (Biological)
结局指标
主要结局
Change from pre-to post-vaccination antibody titer
时间窗: day one- day of vaccine and one month later
Evaluate the immune response in the 5 groups of subjects
次要结局
未报告次要终点
研究者
Flavia Hoyte
Principal Investigator
National Jewish Health