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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究的目的是确定用CVD 909（一种减毒活Vi+ S）预充的预充-加强方案的安全性。伤寒菌株，然后在健康成人志愿者中用许可的胃肠外Vi多糖疫苗加强。本研究将招募来自巴尔的摩社区的健康成人志愿者。将对志愿者进行适当筛选，并在研究活动开始前提供知情同意书。28名健康成人门诊志愿者将随机接受5 × 109 cfu CVD 909伤寒疫苗和缓冲液或单独接受缓冲液安慰剂。三周后，所有志愿者将通过肌内途径接受25 μ g（0.5 ml）许可的纯化Vi多糖疫苗（Typhim，Sanofi Pasteur，前身为Aventis Pasteur）。血液用于血清和ASC对Vi、S.伤寒LPS和O抗原将在Vi加强前后抽取。