Description: 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.)
Timeframe: 2013 - 2014
Geographic Coverage: Baltimore (Md.)

Burlington (Vt.)

Cincinnati (Ohio)

Subject of Study

Subject Domain

Population Age

Adult (19 years to 64 years)

Subject Gender

Female

Male

Keywords