CLINICAL TRIAL: PNEUMOCOCCAL VACCINE RESPONSE IN COPD

临床试验：肺炎球菌疫苗对 COPD 的反应

• 批准号: 7718090
• 负责人: STEVEN M SCHARF
• 金额: $ 2.47万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-03-01 至 2009-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7718090
• 关键词: Adult; Affect; Age; Antibodies; Antibody Formation; Bacteria; Bacterial Infections; Blood; Child; Chronic Obstructive Airway Disease; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Conjugate Vaccines; Diphtheria Toxin; Dose; Elderly; Enrollment; Funding; Grant; Hospitalization; Immune response; Infection; Infection prevention; Institution; Life; Lung; Lung diseases; Maryland; Medical; Meningitis; Names; Patients; Pneumococcal Infections; Pneumococcal vaccine; Pneumonia; Polysaccharides; Proteins; Public Health; Research; Research Personnel; Resources; Risk; Smoker; Source; Streptococcus pneumoniae; Symptoms; Testing; United States; United States Food and Drug Administration; United States National Institutes of Health; Universities; Vaccinated; Vaccines; Work; fighting; health organization; killings; medical schools; novel vaccines; older patient; response

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Chronic Obstructive Pulmonary Disease (COPD) is a disease of the lungs that affects many smokers. Patients with COPD are at increased risk for bacterial infections including those caused by a kind of bacteria named Streptococcus pneumoniae (Pneumococcus). Pneumococcus can cause pneumonia, meningitis, infections of the blood, or COPD ¿exacerbations¿, a temporary worsening of lung symptoms that may require hospitalization and could be life-threatening. At present, most public health organizations recommend that all patients with COPD, as well as anybody over the age of 65, be vaccinated against pneumococcus. The vaccine currently used in adults is the capsular polysaccharide (CPS) vaccine which is made from 23 types of killed pneumococcus. There are almost 100 types of pneumococcus but these 23 are the most common causes of infections in adults. Giving the vaccine causes the body to make antibodies that help fight off pneumococcal infections caused by these 23 types of pneumococcus. Although the vaccine has been shown to prevent infections in young, healthy patients, it appears to be less effective in older patients and in those with underlying medical problems such as COPD. In the last several years, a new vaccine called the protein-conjugate vaccine (PCV) has been developed. Like the CPS vaccine, the PCV is also made from killed pneumococcus but it also contains diphtheria toxin, a substance that appears to increase the body¿s immune response. The vaccine has been used in children under the age of 2 since the year 2000 and has undergone testing in adults. Although the PCV is made from only 7 types of pneumococcus and therefore does not offer protection against as many bacteria as the CPS vaccine, some studies in patients over age 70 suggest that the antibody response to the PCV vaccine may be better than with the CPS vaccine. The Food and Drug Administration approved dose of the PCV vaccine in children is 0.5 mL but it appears that a 1.0 mL dose may work better in adults. In this study, we will try to find out whether 1.0 mL of the PCV vaccine gives a better immune response than the CPS vaccine in patients with moderate to severe COPD. The study is funded by The National Institutes of Health and is conducted by Dr. Steven Scharf from the University of Maryland School of Medicine and researchers from nine other research institutions in the United States. We plan to enroll about 18 patients at the University of Maryland, and 180 patients nationally.

该副本是使用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这是调查员的机构。 慢性阻塞性肺疾病（COPD）是影响许多吸烟者的肺部疾病。 COPD患者患细菌感染的风险增加，包括由一种称为肺炎链球菌（肺炎球菌）的细菌引起的。肺炎球菌会引起肺炎，脑膜炎，血液感染或COPD```病情''，这是对可能需要住院的肺部症状的暂时担忧，可能会危及生命。目前，大多数公共卫生组织建议所有患有COPD的患者以及65岁以上的任何人都接受肺炎球菌的疫苗接种。当前在成年人中使用的疫苗是囊囊多糖（CPS）疫苗，该疫苗是由23种杀死的肺炎球菌制成的。几乎有100种类型的肺炎球菌，但这23个是成年人感染的最常见原因。给予疫苗会导致人体产生抗体，以帮助抵抗由这23种类型的肺炎球菌引起的肺炎球菌感染。尽管已证明该疫苗可以预防年轻，健康患者的感染，但在老年患者和患有COPD等潜在医疗问题的患者中，它似乎效果不佳。在过去的几年中，已经开发了一种称为蛋白质偶联疫苗（PCV）的新疫苗。像CPS疫苗一样，PCV也是由肺炎球菌杀死的，但也包含白喉毒素，这种物质似乎会增加身体的免疫反应。自2000年以来，该疫苗已在2岁以下的儿童中使用，并在成年人中进行了测试。尽管PCV仅由7种类型的肺炎球菌制成，因此不提供针对许多细菌的保护，但在70岁以上的患者中，一些研究表明，对PCV疫苗的抗体反应可能比CPS疫苗更好。食品药品监督管理局批准儿童PCV疫苗的剂量为0.5 mL，但似乎1.0 mL剂量在成人中可能工作得更好。在这项研究中，我们将尝试找出中度至重度COPD患者的1.0 mL PCV疫苗是否比CPS疫苗具有更好的免疫反应。该研究由美国国立卫生研究院资助，由马里兰大学医学院的史蒂文·沙夫（Steven Scharf）博士和美国九个研究机构的研究人员进行。我们计划在马里兰大学注册大约18名患者，在全国范围内注册180名患者。