Thermostable Inactivated Potent Yellow Fever Vaccine

耐热灭活强效黄热病疫苗

基本信息

批准号：
10325436
负责人：
Patricia Veronica Aguilar
金额：
$ 29.94万
依托单位：
UNIVERSAL STABILIZATION TECHNOLOGIES
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-06-23 至 2023-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10325436
关键词：
Acute Adverse reactions Affect Africa Age-Years Area Attenuated Blood Chemical Analysis Body Weight Carbohydrates Clinic Clinical Chemistry Cold Chains Collaborations Communicable Diseases Contracts Development Disease Elderly Electron Beam Epidemic Epitopes Formulation Freeze Drying Functional disorder Glass Goals Hamsters Hour Immobilization Immune system Immunocompromised Host Individual Infection Investigation Laboratories Legal patent Measures Medical Modeling Nucleic Acids Organ Patients Phase Pregnant Women Procedures Process Production Public Health Research Rubber Serum Small Business Technology Transfer Research South America Structure Surface Technology Temperature Testing Texas Tissues Travel Universities Vaccinated Vaccination Vaccines Vacuum Vial device Viral Hemorrhagic Fevers Viral Load result Viral Proteins Virus Virus Replication Yellow Fever Yellow Fever Vaccine Yellow fever virus aged cost fighting high risk innovative technologies irradiation mortality neutralizing antibody new technology novel strategies pathogen pregnant preservation prevent process optimization protective effect protective efficacy respiratory seal stability testing success thermostability vaccine candidate vaccine evaluation vaporization

项目摘要

Summary Yellow Fever (YF) is an acute viral hemorrhagic fever disease caused by Yellow Fever virus (YFV) and an estimated 200,000 YF infections occur annually. Approximately 50% of infected individuals that develop a severe case of the disease will die. The infection is common in Africa and South America, and travelers and residents of those areas are at high risk of contracting the virus. A recent resurgence of YF in Africa and South America has exposed the YFV vaccine supply shortage that is insufficient to fight this major public health problem. In this project, Universal Stabilization Technologies (UST) in collaboration with University of Texas Medical Branch (UTMB) will apply UST’s novel approach for development of thermostable, inactivated, and potent vaccine against YF starting with wild-type YFV. The YFV will be stabilized at ambient temperatures (AT) using UST’s patented “Preservation by Vaporization” (PBV) technology and subsequently inactivated at AT using electron beam (EB) irradiation procedure to produce inactivated and potent vaccine against Yellow Fever. The EB inactivation has been found to inactivate through virus nucleic acid damage without affecting virus surface structures, thus preserving integrity of epitopes, or antigenic determinants recognized by the immune system, while preventing virus replication. The specific aims for this project are the following: • Aim 1: Produce thermostable, electron beam (EB) inactivated Yellow Fever vaccine candidate. • Aim.2. Perform long-term stability testing at low, medium, and high ambient temperatures: 4⁰C. 25⁰C. 37⁰C and short-term testing at 70⁰C. • Aim 3. Evaluate protective efficacy of the YFV vaccine candidate against viscerotropic YF in a hamster model. Our immediate goal is to prove feasibility of a safe, effective, low-cost thermostable vaccine against Yellow Fever virus. The technologies developed in this project could eventually provide a platform technology for quick development of safe, thermostable, and effective vaccines against other emerging diseases.

概括黄热病（Yellow Fever，YF）是由黄热病引起的一种急性病毒性出血热病病毒（YFV），估计每年发生 200,000 例 YF 感染。出现严重疾病的感染者将会死亡。在非洲和南美洲很常见，这些地区的旅行者和居民感染该病毒的高风险最近在非洲和南美洲卷土重来。暴露YFV疫苗供应短缺不足以对抗这一重大公众健康问题。在这个项目中，通用稳定技术（UST）与大学合作德克萨斯医学分会 (UTMB) 将应用 UST 的创新方法来开发以野生型 YFV 为起始原料的耐热、灭活且有效的 YF 疫苗。 YFV 将使用 UST 的专利“Preservation by 汽化”(PBV) 技术，随后使用电子束在 AT 上灭活 (EB) 辐照程序生产灭活的、有效的黄热病疫苗。已发现EB失活是通过病毒核酸损伤而失活，无需影响病毒表面结构，从而保持表位或抗原的完整性免疫系统识别的决定因素，同时防止病毒复制。该项目的具体目标如下： • 目标 1：产生耐热、电子束 (EB) 灭活的黄热病候选疫苗。 • 目标.2。在低、中和高环境下执行长期稳定性测试。温度：4⁰C。37⁰C，短期测试在 70⁰C。 • 目标 3. 评估 YFV 候选疫苗的保护功效仓鼠模型中的内脏 YF。我们的近期目标是证明安全、有效、低成本的热稳定的可行性该项目开发的技术可以预防黄热病病毒。最终为快速开发安全、耐高温、以及针对其他新出现疾病的有效疫苗。