Scientific Core One
科学核心一
基本信息
- 批准号:10589643
- 负责人:
- 金额:$ 37.52万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-01-30 至 2027-12-31
- 项目状态:未结题
- 来源:
- 关键词:Antigen TargetingAntigensBindingBiologicalCellsClinicalCloningComplement 4bComplexDNADataEvaluationFlow CytometryFormulationFred Hutchinson Cancer Research CenterFutureGenetic TranscriptionHIVHarvestIn VitroLiquid substanceMembraneMolecular Sieve ChromatographyNanostructuresPhase I Clinical TrialsProcessProductionProtocols documentationRNARNA amplificationRNA deliveryRNA replicationRNA vaccineResearchRibonucleasesTechniquesTechnologyTestingTransfectionVaccine ProductionVaccinesVenezuelan Equine Encephalitis VirusWestern Blottingbiophysical propertiesdelivery vehicledesignimmunogenicityin vivo evaluationmanufacturenanoparticlenanoparticle deliveryparticleplasmid DNAproduct developmentresearch and developmentstability testingstructured lipidvaccine evaluationvaccine platform
项目摘要
Abstract
Scientific Core One has the responsibility of creating, validating, and providing R&D-grade HIV-Env
immunogen-expressing self-amplifying RNAs (saRNAs) complexed with the nanostructured lipid carrier (NLC)
delivery vehicle to project leads at Fred Hutchinson Cancer Research Center for in vivo testing as described in
Scientific Project One. AAHI’s saRNA/NLC vaccine platform has previously demonstrated robust
immunogenicity against many antigen targets, including HIV, and unparalleled stability. This technology will
now be adapted to deliver the HIV immunogens of our partners at the Fred Hutchinson Cancer Research
Center. Scientific Core One activities include design and cloning of the saRNA template DNA plasmids, saRNA
production using well-characterized and validated in vitro transcription and purification processes, and
manufacturing of the NLC delivery formulation. Upon successful saRNA and NLC manufacture, Scientific Core
One will complex of saRNA/NLC vaccine and test these vaccines in vitro to verify successful saRNA replication
and antigen production. Scientific Core One will also provide transfected cell materials to Scientific Core Two
for immunogen antigenicity testing. Finally, the stability of these R&D-grade saRNA, NLC, and complexed
saRNA/NLC materials will be verified using standard stability testing techniques to gather necessary data to
enable GMP manufacturing by Scientific Project Two, successful filing of an IND and completion of a Phase I
clinical trial.
摘要
Scientific Core One负责创建、验证和提供研发级HIV-Env
与纳米结构脂质载体(NLC)复合的免疫原表达自扩增RNA(saRNA)
递送载体至Fred哈钦森癌症研究中心的项目负责人,用于体内测试,如
科学计划一AAHI的saRNA/NLC疫苗平台此前已证明具有强大的
对许多抗原靶标,包括HIV的免疫原性和无与伦比的稳定性。这项技术将
我们的合作伙伴弗雷德哈钦森癌症研究所的HIV免疫原
中心Scientific Core One的活动包括设计和克隆saRNA模板DNA质粒、saRNA
使用充分表征和验证的体外转录和纯化方法生产,以及
NLC递送制剂的制造。在成功生产saRNA和NLC后,Scientific Core
将saRNA/NLC疫苗复合物并在体外测试这些疫苗以验证成功的saRNA复制
和抗原产生。Scientific Core One还将向Scientific Core Two提供转染的细胞材料
用于免疫原抗原性检测。最后,这些R& D级saRNA、NLC和复合物的稳定性
将使用标准稳定性测试技术验证saRNA/NLC材料,以收集必要的数据,
通过科学项目二实现GMP生产,成功提交IND并完成I期
临床试验
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Corey Casper其他文献
Corey Casper的其他文献
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{{ truncateString('Corey Casper', 18)}}的其他基金
HIV integration-mediated modulation of immune regulation in HPV-associated cancers
HIV 整合介导的 HPV 相关癌症免疫调节调节
- 批准号:
9982848 - 财政年份:2016
- 资助金额:
$ 37.52万 - 项目类别:
HIV integration-mediated modulation of immune regulation in HPV-associated cancers
HIV 整合介导的 HPV 相关癌症免疫调节调节
- 批准号:
9340125 - 财政年份:2016
- 资助金额:
$ 37.52万 - 项目类别:
HIV integration-mediated modulation of immune regulation in HPV-associated cancers
HIV 整合介导的 HPV 相关癌症免疫调节调节
- 批准号:
9129244 - 财政年份:2016
- 资助金额:
$ 37.52万 - 项目类别:
HIV integration-mediated modulation of immune regulation in HPV-associated cancers
HIV 整合介导的 HPV 相关癌症免疫调节调节
- 批准号:
9767057 - 财政年份:2016
- 资助金额:
$ 37.52万 - 项目类别:
Expanding independent research capacity in HIV-associated malignancies in Uganda
扩大乌干达艾滋病毒相关恶性肿瘤的独立研究能力
- 批准号:
8708481 - 财政年份:2014
- 资助金额:
$ 37.52万 - 项目类别:
Biologic Determinants of the Natural History of AIDS-Defining Cancers in Uganda
乌干达艾滋病定义癌症自然史的生物决定因素
- 批准号:
8929189 - 财政年份:2014
- 资助金额:
$ 37.52万 - 项目类别:
Biologic Determinants of the Natural History of AIDS-Defining Cancers in Uganda
乌干达艾滋病定义癌症自然史的生物决定因素
- 批准号:
8793997 - 财政年份:2014
- 资助金额:
$ 37.52万 - 项目类别:
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