Clinical Trials and Ancillary Assays

由HIV-1引起的获得性免疫缺陷综合症（艾滋病）是艾滋病患者死亡的主要原因。 非洲和全球第四大死因。IPCAVD正在开发艾滋病毒/艾滋病疫苗， 使用DMA进行初免，MVA进行加强（DNA/MVA疫苗），以及一种更简单、最终更容易 在这些疫苗的部署形式中，使用MVA进行初免和加强（MVA/MVA疫苗）。两者 DMA和MVA疫苗使用单个载体来表达病毒样颗粒（VLP）。这个IPCAVD寻求建立 GM-CSF，一种佐剂，导入这些产物中用于顺式表达。在临床前研究中， 大大加强了保护。IPCAVD的中心假设是GM-CSF改善了 通过增强粘膜存在的引发的T细胞和Ab应答来保护。进化枝C HIV-1， 在南部非洲和亚洲部分地区流行的占全世界感染的一半左右， > 90%的病例发生在印度，印度是一个感染迅速蔓延的国家，其感染率已超过南非。 案件总数。该IPCAVD的疫苗开发工作集中在开发一个进化枝C 印度的疫苗 该临床研究项目有四个具体目标： 为HVTN-065的1期B提供支持，这是一项正在进行的临床试验，测试进化枝B DNA/MVA， MVA/MVA方案的安全性和免疫原性。 对HVTN 065的I期B部分进行辅助免疫原性试验 提供来自人类志愿者的样本，用于开发粘膜测定 <$提交概念表并帮助HVTN试验评估进化枝的方案开发 在存在和不存在GM-CSF顺式表达的情况下， 为HVTN进化枝C疫苗试验进行辅助免疫原性测定 博士Mark Mulligan是一位经验丰富的临床试验研究者，他将领导HVTN接口， 项目在埃默里。哈里特罗宾逊医生将担任共同私家侦探。并监督辅助化验的进行， 在GeoVax的专门GLP实验室中进行新鲜细胞培养。

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.