Clinical Trials and Ancillary Assays

临床试验和辅助测定

基本信息

批准号：
7280623
负责人：
HARRIET L ROBINSON
金额：
$ 43.72万
依托单位：
GEOVAX, INC.
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-03-01 至 2012-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7280623
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

项目摘要

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) 是人类死亡的主要原因非洲和全球第四大死亡原因该 IPCVD 正在开发艾滋病毒/艾滋病疫苗。使用 DMA 进行初免，使用 MVA 进行加强（DNA/MVA 疫苗）以及更简单、更容易这些疫苗的部署形式，使用 MVA 进行初免和加强（MVA/MVA 疫苗）。 DMA 和 MVA 疫苗使用单个载体来表达病毒样颗粒 (VLP)。 GM-CSF，一种佐剂，加入到这些产品中以顺式表达。在临床前研究中，GMCSF 的共表达。 IPCVD 的一个中心假设是 GM-CSF 改善了保护作用。通过增强引发的 T 细胞和抗体 C 型 HIV-1 反应（即 C 型 HIV-1）的粘膜存在来发挥保护作用。南部非洲和亚洲部分地区的流行病约占全世界感染病例的一半超过 90% 的病例发生在印度，该国感染传播迅速，感染率已超过南非该 IPCAVD 的疫苗开发工作重点是开发 C 分支。印度的疫苗。该临床研究项目有四个具体目标： ¿为 HVTN-065 的 1 b 期提供支持，这是一项正在进行的临床试验，测试分支 B DNA/MVA 和 MVA/MVA 方案的安全性和免疫原性。 ¿对 HVTN 065 的 1 b 期部分进行辅助免疫原性测定 ¿提供人类志愿者的样本用于粘膜检测的开发 ¿提交概念表并帮助开发评估进化枝的 HVTN 试验的方案存在和不存在 GM-CSF 顺式表达的 C 疫苗 ¿对 HVTN C 分支疫苗试验进行辅助免疫原性测定 Mark Mulligan 博士是一位经验丰富的临床试验研究者，他将领导 HVTN 界面埃默里大学项目的 Harriet Robinson 博士将担任联合首席研究员并监督辅助检测的进行。 GeoVax 专用 GLP 实验室中的新鲜细胞。