Clinical Trials and Ancillary Assays

临床试验和辅助测定

• 批准号: 7679565
• 负责人: HARRIET L ROBINSON
• 金额: $ 44.79万
• 依托单位: GEOVAX, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-01 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7679565
• 关键词: Accounting; Acquired Immunodeficiency Syndrome; Adjuvant; Africa; Asia; Biological Assay; Blood; CSF2 gene; Cause of Death; Cells; Clinic; Clinical; Clinical Research; Clinical Trials; Collaborations; Colony-Stimulating Factors; Communication; Complement; Country; DNA/MVA vaccine; Data; Development; Female; Goals; Granulocyte-Macrophage Colony-Stimulating Factor; HIV-1; Human; Human Volunteers; Immune response; India; Infection; Laboratories; Lead; Leadership; Macaca mulatta; Numbers; Phase; Protocols documentation; Research Personnel; Safety; Sampling; South Africa; Southern Africa; Specimen; T-Lymphocyte; Testing; Treatment Protocols; Universities; Vaccines; Virus-like particle; assay development; concept; design; doxorubicin/mitomycin/vinblastine protocol; experience; immunogenicity; improved; preclinical study; protocol development; response; symposium; vaccine development; vector; volunteer

The acquired immunodeficiency syndrome (AIDS) caused by HIV-1 is the leading cause of death in Africa and the fourth leading cause of death worldwide. This IPCAVD is developing HIV/AIDS vaccines that use DMA for priming and MVA for boosting (DNA/MVA vaccine) as well as a simpler an ultimately easier to deploy form of these vaccines, the use of MVA for both priming and boosting (MVA/MVA vaccine). Both the DMA and MVA vaccines use single vectors to express virus like particles (VLP). This IPCAVD seeks to build GM-CSF, an adjuvant, into these products for expression in cis. In preclinical studies, co-expression of GMCSF has substantially enhanced protection. A central hypothesis for the IPCAVD is that GM-CSF improves protection by enhancing the mucosal presence of elicited T cell and Ab responses. Clade C HIV-1 which is endemic in southern Africa and parts of Asia accounts for about one half of the infections worldwide and >90% of the cases in India, a country with a rapidly spreading infection that has surpassed South Africa in its total number of cases. The vaccine development effort of this IPCAVD is focused on developing a clade C vaccine for India. This clinical studies project has four specific aims: ¿ Provide support for phase 1 b of HVTN-065, an ongoing clinical trial testing clade B DNA/MVA and MVA/MVA regimens for safety and immunogenicity. ¿ Conduct ancillary immunogenicity assays for the phase 1 b portion of HVTN 065 ¿ Provide specimens from human volunteers for development of mucosal assays ¿ Submit the concept sheet and help with protocol development for an HVTN trial assessing the clade C vaccines in the presence and absence of GM-CSF expression in cis ¿ Conduct ancillary immunogenicity assays for the HVTN clade C vaccine trial Dr. Mark Mulligan, an experienced clinical trials investigator, will lead the HVTN interface for the project at Emory. Dr. Harriet Robinson will serve as co-P.I. and oversee the conduct of ancillary assays on fresh cells in a dedicated GLP lab at GeoVax.

由HIV-1引起的获得性免疫缺陷综合症(AIDS)是#年的主要死亡原因。 非洲是世界第四大死因。该IPCAVD正在开发艾滋病毒/艾滋病疫苗， 使用DMA用于启动和MVA用于加强(DNA/MVA疫苗)，以及更简单和最终更容易 部署这些疫苗的形式，将MVA用于启动和加强(MVA/MVA疫苗)。这两个 DMA和MVA疫苗使用单一载体表达病毒样颗粒(VLP)。这个IPCAVD试图建立 将佐剂GM-CSF插入到这些产物中，在顺式系统中表达。在临床前研究中，GMCSF的共表达 极大地加强了保护。IPCAVD的一个中心假设是GM-CSF改善了 通过增强粘膜中激发的T细胞和抗体反应的存在来保护。C分支HIV-1是 南部非洲和亚洲部分地区的地方病约占全球感染人数的一半， 在印度，90%的病例发生在一个感染迅速传播的国家，这个国家已经超过了南非 病例总数。IPCAVD的疫苗开发工作重点是开发一种C分支 印度的疫苗。 这项临床研究项目有四个具体目标： ？为HVTN-065的第1阶段b、正在进行的临床试验测试分支B DNA/MVA以及 MVA/MVA方案的安全性和免疫原性。 ？对HVTN 065的1b期部分进行辅助免疫原性检测 ？提供来自人类志愿者的标本，用于发展粘膜分析 ？提交概念表并帮助制定评估该分支的HVTN试验方案 在顺式细胞中存在和不表达GM-CSF的C疫苗 ？为HVTN分支C疫苗试验进行辅助免疫原性分析 马克·穆里根博士是一位经验丰富的临床试验研究员，他将领导HVTN接口 埃默里的项目。哈里特·罗宾逊博士将担任副私家侦探，并监督辅助化验的进行 在GeoVax的GLP专用实验室中的新鲜细胞。