A MULTICENTER, OPEN-LABEL PHASE I/II STUDY TO EVALUATE SAFETY AND IMMUNOGENICITY

评估安全性和免疫原性的多中心、开放标签 I/II 期研究

• 批准号: 7717556
• 负责人: MITCHELL J GOLDMAN
• 金额: $ 2.16万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717556
• 关键词: Adverse event; CD4 Lymphocyte Count; Collection; Computer Retrieval of Information on Scientific Projects Database; Electrocardiogram; Funding; Grant; HIV; Institution; Label; Laboratories; Phase; Research; Research Personnel; Resources; Safety; Smallpox; Smallpox Vaccine; Source; Testing; United States National Institutes of Health; Vaccination; Vaccines; Visit; Week; base; immunogenicity

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. This is a multicenter, open-label, parallel-group Phase I/II study to evaluate safety and immunogenicity of MVA-BN smallpox vaccine in HIV infected subjects (with CD4 counts 350 / ¿l) with or without previous smallpox vaccination compared to healthy subjects with or without previous smallpox vaccination. A total of 150 subjects will be assigned to four treatment groups based on HIV status and previous smallpox vaccination status. The investigational vaccine 0.5 ml MVA-BN¿ containing 1x108 TCID50 will be administered subcutaneously. HIV infected subjects and healthy subjects who have not received smallpox vaccination previously will receive two vaccinations 4 weeks apart. HIV infected subjects and healthy subjects who have received smallpox vaccination previously will receive one vaccination. Study duration will be 34 to 39 weeks and include 5 to 7 visits. Subjects will undergo physical exams, electrocardiograms, adverse event collection, and laboratory testing for safety and immunogenicity.

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。 这是一项多中心、开放标签、平行组I/II期研究，旨在评价MVA-BN天花疫苗在既往接种或未接种天花疫苗的HIV感染受试者（CD 4计数350 /L）中与既往接种或未接种天花疫苗的健康受试者相比的安全性和免疫原性。 根据HIV状态和既往天花疫苗接种状态，将共计150例受试者分配至4个治疗组。将皮下接种含有1x 108 TCID 50的0.5 ml MVA-BN ²研究疫苗。 既往未接种天花疫苗的HIV感染受试者和健康受试者将间隔4周接种两次疫苗。 既往接种过天花疫苗的HIV感染受试者和健康受试者将接种一次疫苗。研究持续时间为34 - 39周，包括5 - 7次访视。 受试者将接受体格检查、心电图、不良事件收集以及安全性和免疫原性实验室检测。