UMB Data Catalog

A project of the Health Sciences and Human Services Library
UMB Dataset

Protection from Cholera with CVD 103-HgR

Alternate Titles(s): Efficacy of Single-Dose Live Oral Cholera Vaccine CVD 103-HgR
UID: 15
Author(s): Wilbur H. Chen*, Myron M. Levine
* Corresponding Author
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
Vaccines
Population Age
Adult (19 years to 64 years)
Subject Gender
Female
Male
Keywords
Cholera Vaccines
CVD 103-HgR
PaxVax, Inc.
PXVX0200
Vaxchora
Vibrio cholerae O1

Access

Restrictions
Approval required
Registration required
Instructions
Submit application. PaxVax approval required.
Access via Application

Online Application Form

Associated Publications
Chen WH, Cohen MB, Kirkpatrick, BD, Brady RC, Galloway D, Gurwith M, Hall RH, Kessler RA, Lock M, Haney D, Lyon CE, Simon JK, Szabo F, Levine MM. Single-dose live oral cholera vaccine CVD 103-HgR protects against human experimental infection with vibrio cholerae O1 El Tor. Clinical Infectiuous Diseases 2016; 62:1329-35
Data Type
Clinical Measures
Demographic
Immunology Laboratory Measures
Equipment Used
Paper Source Documents
Software Used
Proprietary Record Collection Database
Study Type
Interventional
Dataset Format(s)
Microsoft Excel
Dataset Size
Variable Based on Data Requested
Grant Support
Fully Funded by PaxVax, Inc./PaxVax, Inc.