CLINICAL TRIAL: PHASE I PRIME-BOOST STUDY OF VI POLYSACCHARIDE TYPHOID VACCINE A

临床试验：VI多糖伤寒疫苗A的I期初免-加强研究

• 批准号: 7951156
• 负责人: Carol Tacket
• 金额: $ 0.44万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951156
• 关键词: Adult; Attenuated; Baltimore; Buffers; Clinical Research; Communities; Computer Retrieval of Information on Scientific Projects Database; Consent; Funding; Grant; Institution; Intramuscular; Licensing; Life; O Antigens; Outpatients; Phase I Clinical Trials; Placebos; Polysaccharides; Randomized; Recruitment Activity; Research; Research Personnel; Resources; Route; Safety; Salmonella typhi; Serum; Source; Treatment Protocols; Typhoid Vaccine; United States National Institutes of Health; Vaccines; Writing; response; volunteer

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. The purpose of this study is to determine the safety of the prime-boost regimen of priming with CVD 909, a live attenuated Vi+ S. Typhi strain, followed by boosting with licensed parenteral Vi polysaccharide vaccine in healthy adult volunteers. Healthy adult volunteers from the Baltimore community will be recruited for this study. Volunteers will be appropriately screened and will give informed, written consent before study activities begin. Twenty-eight healthy adult outpatient volunteers will be randomized to receive either 5x109 cfu of CVD 909 typhoid vaccine with buffer or buffer placebo alone. Three weeks later, all volunteers will receive 25 ug (0.5 ml) of licensed purified Vi polysaccharide vaccine (Typhim, Sanofi Pasteur, formerly Aventis Pasteur) by the intramuscular route. Blood for serum and ASC responses to Vi, S. Typhi LPS, and O antigen will be drawn before and after the Vi boost.

该副本是利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，这不一定是调查员的机构。 这项研究的目的是确定用CVD 909（一种活衰减的VI+ S. Typhi菌株）启动启动方案的安全性，然后在健康的成人志愿者中使用持牌的肠胃外VI多糖疫苗提高持牌肠胃外VI多糖疫苗。这项研究将招募来自巴尔的摩社区的健康成人志愿者。志愿者将进行适当的筛查，并在开始学习活动之前给予知情的书面同意。 28个健康的成人门诊志愿者将被随机分配，单独接受5x109 CFU的CVD 909伤寒疫苗。三周后，所有志愿者将通过肌肉内途径获得25 ug（0.5 mL）的许可纯化的VI多糖疫苗（Typhim，Sanofi Pasteur，以前为Aventis Pasteur）。在VI增强之前和之后，将抽取血清和ASC对VI，Typhi S. typhi LP和O抗原的血液。