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利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 包括诺沃克在内的诺如病毒是一种不可培养的人类杯状病毒，已成为非细菌性胃肠炎疫情爆发的唯一最重要原因。非细菌性胃肠炎是一种急性衰弱疾病，以发烧、头痛、呕吐和腹泻为特征。据疾控中心估计，仅在美国，每年就有2300万例急性胃肠炎是由诺沃克病毒引起的，这给企业、医院、学校和其他应对疫情的封闭场所造成了巨大的社会经济损失。这些病毒也是全球非细菌性胃肠炎爆发的最常见原因，急性病毒性胃肠炎是婴儿死亡的主要原因。该方案中要研究的新疫苗是基于诺瓦克病毒样颗粒(VLP)作为免疫原的。Norwalk VLP是非传染性的，因为它们不包含病毒基因组RNA，它们具有高度的免疫原性，因为它们保留了颗粒抗原确认和结构，以模拟病毒与细胞受体的功能相互作用，从而引发强大的宿主免疫反应。

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.