Clinical Trials and Ancillary Assays
Clinical Trials and Ancillary Assays
批准号:
7280623
负责人:
HARRIET L ROBINSON
金额:
$43.72万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2007
资助国家:
美国
项目状态:
已结题
起止时间:
2007-03-01 至 2012-08-31
关键词:
AccountingAcquired Immunodeficiency SyndromeAdjuvantAfricaAsiaBiological AssayBloodCSF2 geneCause of DeathCellsClinicClinicalClinical ResearchClinical TrialsCollaborationsColony-Stimulating FactorsCommunicationComplementCountryDNA/MVA vaccineDataDevelopmentFemaleGoalsGranulocyte-Macrophage Colony-Stimulating FactorHIV-1HumanHuman VolunteersImmune responseIndiaInfectionLaboratoriesLeadLeadershipMacaca mulattaNumbersPhaseProtocols documentationResearch PersonnelSafetySamplingSouth AfricaSouthern AfricaSpecimenT-LymphocyteTestingTreatment ProtocolsUniversitiesVaccinesVirus-like particleassay developmentconceptdesigndoxorubicin/mitomycin/vinblastine protocolexperienceimmunogenicityimprovedpreclinical studyprotocol developmentresponsesymposiumvaccine developmentvectorvolunteer
中文摘要
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。
英文摘要
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.
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
Enhancing protective antibody responses for a GM-CSF adjuvanted HIV vaccine
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批准号:8709988
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项目类别:
-
资助金额:$28.96万
-
财政年份:2013
-
负责人:HARRIET L ROBINSON
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依托单位:
Project 1: Immunogens and Manufacturing
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批准号:8478317
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项目类别:
-
资助金额:$185.9万
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财政年份:2012
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负责人:HARRIET L ROBINSON
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依托单位:
DNA/MVA IMMUNOGENS, CROSS-CLADE RESPONSES
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批准号:7715685
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项目类别:
-
资助金额:$8.16万
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财政年份:2008
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负责人:HARRIET L ROBINSON
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依托单位:
Administrative Core
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批准号:7694038
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项目类别:
-
资助金额:$30.46万
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财政年份:2008
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负责人:HARRIET L ROBINSON
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依托单位:
Clinical Trials and Ancillary Assays
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批准号:7679565
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项目类别:
-
资助金额:$44.79万
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财政年份:2008
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负责人:HARRIET L ROBINSON
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依托单位:
Administrative Support
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批准号:7280624
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项目类别:
-
资助金额:$34.21万
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财政年份:2007
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负责人:HARRIET L ROBINSON
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依托单位:
GM-CSF-Adjuvanted Clade C DNA/MVA and MVA/MVA Vaccines
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批准号:7497586
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项目类别:
-
资助金额:$347.87万
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财政年份:2007
-
负责人:HARRIET L ROBINSON
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依托单位:
GM-CSF-Adjuvanted Clade C DNA/MVA and MVA/MVA Vaccines
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批准号:7938758
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项目类别:
-
资助金额:$488.51万
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财政年份:2007
-
负责人:HARRIET L ROBINSON
-
依托单位:
GM-CSF-Adjuvanted Clade C DNA/MVA and MVA/MVA Vaccines
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批准号:7269092
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项目类别:
-
资助金额:$291.51万
-
财政年份:2007
-
负责人:HARRIET L ROBINSON
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依托单位:
DNA/MVA IMMUNOGENS, CROSS-CLADE RESPONSES
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批准号:7562528
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项目类别:
-
资助金额:$10.47万
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财政年份:2007
-
负责人:HARRIET L ROBINSON
-
依托单位:
GM-CSF-Adjuvanted Clade C DNA/MVA and MVA/MVA Vaccines
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批准号:7679567
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项目类别:
-
资助金额:$473.63万
-
财政年份:2007
-
负责人:HARRIET L ROBINSON
-
依托单位:
GM-CSF-Adjuvanted Clade C DNA/MVA and MVA/MVA Vaccines
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批准号:8132550
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项目类别:
-
资助金额:$435.23万
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财政年份:2007
-
负责人:HARRIET L ROBINSON
-
依托单位:
DNA/MVA IMMUNOGENS, CROSS-CLADE RESPONSES
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批准号:7349168
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项目类别:
-
资助金额:$10.74万
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财政年份:2006
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负责人:HARRIET L ROBINSON
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依托单位:
PROJECT 1: DNA AND MVA IMMUNOGENS
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批准号:7349169
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项目类别:
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资助金额:$10.74万
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财政年份:2006
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负责人:HARRIET L ROBINSON
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依托单位:
DNA AND PROTEIN IMMUNOGENS FOR SIV/HIV VACCINES
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批准号:7349125
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项目类别:
-
资助金额:$10.74万
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财政年份:2006
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负责人:HARRIET L ROBINSON
-
依托单位:
PROJECT 1: DNA IMMUNOGENS AND PRECLINICAL TRIALS
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批准号:7165903
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项目类别:
-
资助金额:$9.64万
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财政年份:2005
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负责人:HARRIET L ROBINSON
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依托单位:
PROJECT 1: DNA AND MVA IMMUNOGENS
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批准号:7165900
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项目类别:
-
资助金额:$9.64万
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财政年份:2005
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负责人:HARRIET L ROBINSON
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依托单位:
DNA/MVA IMMUNOGENS, CROSS-CLADE RESPONSES
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批准号:7165899
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项目类别:
-
资助金额:$9.64万
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财政年份:2005
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负责人:HARRIET L ROBINSON
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依托单位:
DNA AND PROTEIN IMMUNOGENS FOR SIV/HIV VACCINES
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批准号:7165848
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项目类别:
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资助金额:$9.64万
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财政年份:2005
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负责人:HARRIET L ROBINSON
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依托单位:
BASIC PRINCIPALS OF DNA-BASED IMMUNIZATIONS
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批准号:6970936
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项目类别:
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资助金额:$3.58万
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财政年份:2004
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负责人:HARRIET L ROBINSON
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依托单位:
海外基金