Preliminary Assessment of the Safety and Immunogenicity of a New CTXPhi-negative, Hemagglutinin/protease-defective El Tor Strain As a Cholera Vaccine Candidate

Overview

Journal Infect Immun

Publisher American Society for Microbiology

Specialty Allergy & Immunology

Date 1999 Jan 23

PMID 9916056

Citations 29

Authors

J A Benitez

L Garcia

A Silva

H Garcia

R Fando

B Cedre

J Campos

B L Rodriguez

J L Perez

T Valmaseda

O Perez

A Perez

M Ramirez

T Ledon

M D Jidy

M Lastre

L Bravo

G Sierra

Affiliations

Soon will be listed here.

Abstract

Vibrio cholerae 638 (El Tor, Ogawa), a new CTXPhi-negative hemagglutinin/protease-defective strain that is a cholera vaccine candidate, was examined for safety and immunogenicity in healthy adult volunteers. In a double-blind placebo-controlled study, no significant adverse reactions were observed in volunteers ingesting strain 638. Four volunteers of 42 who ingested strain 638 and 1 of 14 who received placebo experienced loose stools. The strain strongly colonized the human small bowel, as evidenced by its isolation from the stools of 37 of 42 volunteers. V. cholerae 638, at doses ranging from 4 x 10(7) to 2 x 10(9) vibrios, elicited significant serum vibriocidal antibody and anti-Ogawa immunoglobulin A antibody secreting cell responses.

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