CLINICAL TRIAL: PHASE I STUDY OF INTRANASAL NORWALK VLP VACCINE WITH ADJUVANT &

临床试验：鼻内 NORWALK VLP 疫苗与佐剂的 I 期研究

• 批准号: 7951170
• 负责人: Carol Tacket
• 金额: $ 3.33万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951170
• 关键词: Acute; Adjuvant; Antigens; Businesses; Calicivirus; Centers for Disease Control and Prevention (U.S.); Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Diarrhea; Disease Outbreaks; Epidemic; Fever; Funding; Gastroenteritis; Genomics; Grant; Headache; Hospitals; Human; Immune response; Infant Mortality; Institution; Norovirus; Norwalk virus; Particulate; Phase I Clinical Trials; Protocols documentation; Research; Research Personnel; Resources; Schools; Source; Structure; United States National Institutes of Health; Vaccines; Viral; Viral Gastroenteritis; Virus; Virus-like particle; Vomiting; base; functional mimics; immunogenic; novel vaccines; receptor; socioeconomics

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Noroviruses, including Norwalk, are non-cultivatable human Caliciviruses that have emerged as the single most significant cause of epidemic outbreaks of nonbacterial gastroenteritis, which is an acute debilitating illness characterized by a fever, headache, vomiting and diarrhea. According to CDC estimates, 23 million cases of acute gastroenteritis are due to Norovirus each year in the U.S. alone placing a significant socioeconomic toll on businesses, hospitals, schools and other closed settings dealing with outbreaks. These viruses are also the most common cause of outbreaks of nonbacterial gastroenteritis worldwide, where acute viral gastroenteritis is a leading cause of infant mortality. The new vaccine to be studied in this protocol is based on Norwalk Virus-Like-Particles (VLP) as the immunogen. Norwalk VLPs are non-infectious because they do not contain viral genomic RNA, and they are highly immunogenic because they preserve particulate antigen confirmation and structure to mimic functional interactions of the virus with cellular receptors, thereby eliciting a strong host immune response.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 包括诺瓦（Norwalk）在内的诺病毒是不可培养的人蜡膜病毒，它们已成为非细菌性胃肠炎流行病爆发的唯一重要原因，这是一种急性衰弱的疾病，其特征是发烧，头痛，呕吐和腹泻。根据疾病预防控制中心（CDC）的估计，仅美国，每年在美国，诺如病毒造成的急性胃肠炎病例为2300万例，对企业，医院，学校和其他处理暴发的封闭环境造成了重大的社会经济损失。这些病毒也是全世界非细菌胃炎爆发的最常见原因，那里的急性病毒性胃肠炎是婴儿死亡率的主要原因。在该方案中要研究的新疫苗基于诺沃克病毒样粒子（VLP）作为免疫原。 Norwalk VLP是非感染的，因为它们不含病毒基因组RNA，并且它们具有高度免疫原性，因为它们可以保留颗粒状抗原的确认和结构，以模仿病毒与细胞受体的功能相互作用，从而引发了强大的宿主免疫反应。