Development of a Universal Influenza Vaccine

通用流感疫苗的开发

• 批准号: 8692600
• 负责人: Frank R. Jones
• 金额: $ 139.87万
• 依托单位: ETUBICS CORPORATION
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-10 至 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8692600
• 关键词: Adenoviruses; Adverse effects; Animal Model; Animals; Antibodies; Antibody Formation; Antigen-Presenting Cells; Antigens; Biodistribution; Bioreactors; Birds; Cancer Model; Cancer Patient; Carcinoembryonic Antigen; Cellular Immunity; Clinical; Clinical Treatment; Clinical Trials; Codon Nucleotides; Colorectal Cancer; Communicable Diseases; Consensus Sequence; Control Animal; DNA-Directed DNA Polymerase; Data; Development; Disease; Dose; ERBB2 gene; Epidemic; Ferrets; Freeze Drying; Freezing; Frequencies; Future; Generations; Genes; H1N1 vaccine; Hemagglutination; Hemagglutinin; Human; Immune; Immune response; Immunity; Immunization; Immunotherapeutic agent; Infection; Influenza; Influenza A Virus, H1N1 Subtype; Influenza A Virus, H5N1 Subtype; Influenza Hemagglutinin; Life; M2 protein; Modeling; Mus; Nucleoproteins; Patients; Phase; Phase I Clinical Trials; Populations at Risk; Property; Proteins; Recombinant Vaccines; Recombinants; Regimen; SIV; Safety; Serotyping; System; Technology; Testing; Therapeutic; Toxic effect; Toxicology; Transgenes; Vaccinated; Vaccination; Vaccine Production; Vaccines; Virulent; Virus; Virus Shedding; base; flu; good laboratory practice; immunogenic; immunogenicity; in vivo; influenza virus vaccine; influenzavirus; innovation; malignant breast neoplasm; metastatic colorectal; multiple myeloma M Protein; nonhuman primate; novel; novel vaccines; pandemic disease; pandemic influenza; preclinical study; prevent; protein expression; public health relevance; response; stability testing; tumor; vaccine candidate; vaccine evaluation; vaccinology; vector; viral DNA

DESCRIPTION (provided by applicant): This application focuses on development of efficacious universal influenza vaccine. Specifically, we will capitalize on the innovative attributes of our new Ad5 [E1-, E2b-] recombinant platform and develop a broadly cross-reactive "flu" vaccine. This will be accomplished by incorporating into our recombinant Ad5 [E1-, E2b-] platform fused transgenes that will express conserved and cross-reactive antigens from the HA, BM2, M2 and NP proteins of influenza A and B strains to be utilized as a new vaccine. The vaccine will be tested in mice and ferrets for its efficacy against various influenza A and B viruses, including highly pathogenic avian H5N1 viruses. In the last years we will perform toxicology and biodistribution studies under GLP and finalize the vaccine stability studies in order to prepare an IND application with the FDA.

描述（由申请人提供）：本申请的重点是开发有效的通用流感疫苗。具体来说，我们将利用我们新的 Ad5 [E1-，E2b-] 重组平台的创新属性，开发一种广泛交叉反应的“流感”疫苗。这将通过将融合转基因整合到我们的重组 Ad5 [E1-、E2b-] 平台中来实现，该转基因将表达来自甲型和乙型流感病毒株的 HA、BM2、M2 和 NP 蛋白的保守且交叉反应的抗原，以用作新疫苗。该疫苗将在小鼠和雪貂身上测试其对抗各种甲型和乙型流感病毒（包括高致病性禽 H5N1 病毒）的功效。在过去的几年里，我们将根据 GLP 进行毒理学和生物分布研究，并完成疫苗稳定性研究，以便向 FDA 准备 IND 申请。