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Universal Influenza A/B Vaccine

通用甲型/乙型流感疫苗

基本信息

批准号：
10539015
负责人：
Kenneth C Bagley
金额：
$ 100万
依托单位：
ORLANCE, INC.
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-08-07 至 2025-04-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10539015
关键词：
Antibodies Antibody Response Antigen-Presenting Cells Antigens Body Weight decreased Cells Clinical Clinical Trials Companions DNA DNA Vaccines DNA delivery Data Development Devices Dose Electroporation Engineering Exhibits Ferrets Formulation Gold Human Humoral Immunities Immune Immune response Immunologics Inflammation Inflammatory Response Influenza Influenza A virus Influenza B Virus Injections Liquid substance Lung Macaca Macaca fascicularis Macaca mulatta Modeling Mucosal Immune Responses Mucous Membrane Mus Pathogenesis Phase Population Pre-Clinical Model Preclinical Testing Predisposition Publishing Reagent Reporting Role Safety Site Skin Small Business Innovation Research Grant Strategic Planning Syringes T cell response T-Lymphocyte Testing Toxic effect United States National Institutes of Health Vaccinated Vaccination Vaccine Antigen Vaccines Viremia Virus Virus Replication design experience gene gun immunogenicity influenza virus strain influenzavirus innovation next generation nonhuman primate novel pre-clinical protective efficacy response universal influenza vaccine unvaccinated vaccine delivery vaccine development vaccine evaluation

项目摘要

Abstract Universal influenza vaccines should be possible if conserved antigens of influenza are effectively targeted and effective antiviral immune responses are generated against those antigens. DNA vaccination is an appealing approach for delivering universal influenza vaccines, however, natural immune responses to conserved influenza antigens are typically weak and most DNA vaccines tested in humans have not elicited robust humoral immunity. To overcome the obstacles to developing universal influenza DNA vaccines, we are using novel composite immunogens and delivering them with a next generation Gene Gun device that combines several engineering and formulation innovations that increase immunogenicity by increasing the number of skin cells and antigen presenting cells expressing vaccine antigen. We have already obtained encouraging results with a universal influenza A (UFluA) DNA vaccine. Under this SBIR proposal, we intend to test a companion universal influenza B (UFluB) DNA vaccine to create a more comprehensive universal A/B vaccine (UFluA/B) that will provide broad protective coverage from all influenza A and B types capable of infecting humans. If we are successful at demonstrating that a single UFluA/B DNA vaccine can induce broad responses and protection in mice in the phase I effort, we will advance this this product to preclinical testing under the phase II portion of this application where we will investigate immunogenicity and protective efficacy in naïve and pre-immune ferrets and safety and efficacy in a nonhuman primate model that closely resembles humans in their dosing, immune response to DNA vaccination and susceptibility to influenza. If successful, these data will provide Orlance with a strong preclinical IND data package to advance this strategy to phase I human clinical trials. 2

摘要