A Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Older Adults

Status:	Completed
Conditions:	Infectious Disease, Gastrointestinal
Therapuetic Areas:	Gastroenterology, Immunology / Infectious Diseases
Healthy:	No
Age Range:	46 - 64
Updated:	4/21/2016
Start Date:	May 2014
End Date:	June 2015

A Phase III Randomized, Double-blind, Placebo-controlled Study in Older Adults to Assess Immunogenicity and Clinical Acceptability of a Single-dose of the Live Oral Cholera Vaccine Candidate PXVX0200 Vibrio Cholerae O1 Serotype Inaba Vaccine Strain CVD 103-HgR

Demonstrate that the vaccine offers protection based on antibody levels in older adults and
is similar to antibody levels in adults aged 18-45 following vaccination with PXVX0200.

Inclusion Criteria:

- healthy men or women,

- age 46 to 64 years inclusive;

- normal medical history and physical examination

- Women must have a negative pregnancy test

Exclusion Criteria:

- travel to a cholera endemic area in the previous 5 years;

- abnormal stool pattern or regular use of laxatives;

- Currently active unstable or undiagnosed medical conditions

- current or recent antibiotic use;

- pregnancy or nursing;

- Previously received a licensed or investigational cholera vaccine

- History of cholera or enterotoxigenic E. coli infection

- History of Guillain-Barré Syndrome

- Received or plans to receive any other licensed vaccines, except for seasonal
influenza

- Recipient of bone marrow or solid organ transplant

- Malignancy (excluding non-melanotic skin cancers) or lymphoproliferative
disorders diagnosed or treated during the past 5 years

- Use of systemic chemotherapy in the previous 5 years prior to the study

- any immunosuppressive medical condition

We found this trial at

sites

University of Kentucky

Lexington, Kentucky

859) 257-9000