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

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 诺如病毒，包括诺瓦克病毒，是不可培养的人类杯状病毒，其已经成为非细菌性胃肠炎流行性爆发的单一最重要原因，非细菌性胃肠炎是一种急性衰弱性疾病，其特征在于发烧、头痛、呕吐和腹泻。据CDC估计，仅在美国，每年就有2300万例急性胃肠炎病例是由诺如病毒引起的，这对企业、医院、学校和其他应对疫情的封闭环境造成了重大的社会经济损失。这些病毒也是全球非细菌性胃肠炎爆发的最常见原因，其中急性病毒性胃肠炎是婴儿死亡的主要原因。本方案中研究的新疫苗是基于诺瓦克病毒样颗粒（VLP）作为免疫原。诺瓦克VLP是非感染性的，因为它们不含病毒基因组RNA，并且它们是高度免疫原性的，因为它们保留颗粒抗原确认和结构以模拟病毒与细胞受体的功能性相互作用，从而引发强烈的宿主免疫应答。

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.