Protection from Cholera with CVD 103-HgR

This dataset is the result of a phase 3, randomized, double-blind, placebo-controlled efficacy trial of a single dose live oral cholera vaccine. PXVX0200 was developed to rapidly confer protection to humanitarian relief workers and other travelers visiting cholera-endemic areas as well as residents in regions experiencing outbreaks. Existing licensed vaccines require 2 or 3 (children) doses weeks apart. The trial consisted of 3 groups of volunteers each of which were randomly split into receiving either the PXVX0200 vaccine or a placebo. One group was challenged with virulent V. cholera O1 El Tor Inaba strain N16961 inoculum 10 days post-vaccination. A second group was challenged 3 months post-vaccination, while individuals in the third group remained unchallenged. A total of 197 volunteers participated in the trial. This dataset includes demographics and clinical and immunology measures from the 3 study sites: University of Maryland, Baltimore School of Medicine, Cincinnati Children’s Hospital Medical Center, Ohio, and the Vaccine Testing Center, University of Vermont College of Medicine. (National clinical trial registry number: NCT01895855; Research funded by: PaxVax, Inc.)

本数据集源于一项第三阶段的、随机化、双盲、安慰剂对照的有效性试验，试验对象为一次性活口服霍乱疫苗。PXVX0200疫苗的开发旨在为援助工作人员以及其他前往霍乱疫区的旅行者，以及遭受疫情地区居民提供快速的保护。现有的授权疫苗需在数周内分两次或三次（儿童）接种。试验分为三组志愿者，每组志愿者均随机分为接受PXVX0200疫苗或安慰剂。其中一组在疫苗接种后10天接受具有致病性的V. cholera O1 El Tor Inaba菌株N16961的接种挑战。第二组在疫苗接种后3个月接受挑战，而第三组的个体则未接受挑战。共有197名志愿者参与了此次试验。本数据集包含来自三个研究地点的人口统计学、临床和免疫学指标：马里兰大学医学院、辛辛那提儿童医院医学中心，俄亥俄州，以及佛蒙特大学医学院疫苗检测中心。（国家临床试验注册号：NCT01895855；研究资金由PaxVax，Inc.提供）