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Production of a Chimpanzee Adenovirus HIV-1 Vaccine

Production of a Chimpanzee Adenovirus HIV-1 Vaccine
黑猩猩腺病毒 HIV-1 疫苗的生产
批准号：
10653676
负责人：
TIMOTHY FOUTS
金额：
$11.56万
依托单位：
ADVANCED BIOSCIENCE LABORATORIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
项目状态：
未结题
起止时间：
2016-09-26 至 2025-08-28
来源：
https://reporter.nih.gov/project-details/10653676
关键词：
AdenovirusesClinicalContractsDevelopmentDocumentationFeasibility StudiesFormulationGenerationsHIV-1 vaccineInvestigational DrugsInvestigator-Initiated ResearchMosaicismNational Institute of Allergy and Infectious DiseasePan GenusPharmaceutical PreparationsPhasePreclinical TestingProductionReagentRecombinantsT-LymphocyteTechnology TransferTestingVaccinesflexibilitypreclinical developmentprogramsresearch clinical testingresearch studysafety testingscale upstability testing

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中文摘要
翻译
该合同将为NIAID提供广泛而灵活的非传统，主动和以开发为导向的能力，为有前途的产品提供临床前开发支持，当这些产品从制药商发起的研究中出现时。这些能力将使NIAID能够更快、更有效地缩小开发和生产差距。活动包括但不限于小规模生产、临床前试验和文件编制，以提交研究性新药（IND）进行I、II和III期临床试验。 特别是，该项目将侧重于生产腺病毒HIV-1疫苗。
英文摘要
This contract will provide NIAID with a broad and flexible range of nontraditional, proactive and developmentally-oriented capabilities to provide preclinical development support for promising products when such products emerge from investigator-initiated research studies. These capabilities will allow NIAID to more rapidly and efficiently close development and production gaps. Activities include but are not limited to small-scale production, preclinical testing and documentation leading to Investigational New Drug (IND) submission for Phase I, II, and III clinical testing. In particular this project will focus on the production of an adenovirus HIV-1 vaccine.
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NIAID Preclinical Development Support: Essential Core Activities
NIAID Preclinical Development Support: Essential Core Activities
cGMP Manufacture, Fill-Finish, Release, and Stability Testing of a Nanoparticle Based HIV Envelope Containing Vaccine
cGMP Manufacture, Fill-Finish, Release, and Stability Testing of a Nanoparticle Based HIV Envelope Containing Vaccine
国内基金
海外基金
Molecular Interaction Reconstruction of Rheumatoid Arthritis Therapies Using Clinical Data