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Development/Production-Alternative Serotype HIV Recombinant Adenoviral Vaccine

Development/Production-Alternative Serotype HIV Recombinant Adenoviral Vaccine
开发/生产-替代血清型HIV重组腺病毒疫苗
批准号：
8946607
负责人：
Richard Schwartz
金额：
$215.99万
依托单位：
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
依托单位国家：
美国
项目类别：
财政年份：
--
资助国家：
美国
项目状态：
未结题
起止时间：
至
来源：
https://reporter.nih.gov/project-details/8946607
关键词：
Biomedical ResearchClinicClinical TrialsContractsDevelopmentDoseHIVHIV vaccineHumanImmune responseLaboratoriesLaboratory StudyNational Institute of Allergy and Infectious DiseasePan GenusPhase I Clinical TrialsPlacebosPlantsProductionRecombinantsSerotypingVaccine ProductionVaccinesclinical materialdesignphase 1 studypreclinical safetypreclinical studyprogramssafety study

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中文摘要
翻译
该项目旨在制备GMP质量的可替代血清型（黑猩猩腺病毒3型）艾滋病毒疫苗，并完成开始临床试验所需的临床前和实验室研究。第一项临床试验是一期研究，目的是检查HIV疫苗的耐受性、剂量和免疫反应。我们的假设是，这种疫苗对人类接种是安全的，并能引发对艾滋病毒的免疫反应。临床材料已按照现行的良好生产规范（cGMP）生产，并已发布用于I期临床试验
英文摘要
This project is designed to prepare a GMP quality investigational alternative serotypes (chimpanzee Adeno type 3) HIV vaccine and complete the preclinical and laboratory studies needed to begin a clinical trial. The first clinical trial is a Phase I study to examine tolerability, dose, and immune response of the HIV vaccine. The hypothesis is that this vaccine will be safe for human administration and elicit immune responses to HIV. Clinical materials have been manufactured in compliance with current Good Manufacturing Practices (cGMP) and released for use in Phase I clinical trials
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