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Microbial Immunity and Vaccines

Construction and Characterization of Genetically Definedaro omp Mutants of Enterotoxigenic Escherichia coli and Preliminary Studies of Safety and Immunogenicity in Humans

Arthur K. Turner, Tamsin D. Terry, David A. Sack, Patricia Londoño-Arcila, Michael J. Darsley
Arthur K. Turner
Acambis Ltd., Cambridge CB1 9PT, United Kingdom, 1 and
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Tamsin D. Terry
Acambis Ltd., Cambridge CB1 9PT, United Kingdom, 1 and
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David A. Sack
Vaccine Testing Unit, School of Hygiene and Public Health, Johns Hopkins University, Baltimore, Maryland 2
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Patricia Londoño-Arcila
Acambis Ltd., Cambridge CB1 9PT, United Kingdom, 1 and
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Michael J. Darsley
Acambis Ltd., Cambridge CB1 9PT, United Kingdom, 1 and
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DOI: 10.1128/IAI.69.8.4969-4979.2001
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This article has a correction. Please see:

  • Construction and Characterization of Genetically Definedaro omp Mutants of Enterotoxigenic Escherichia coli and Preliminary Studies of Safety and Immunogenicity in Humans
    - October 01, 2001

ABSTRACT

Enterotoxigenic Escherichia coli (ETEC) is a leading cause of diarrhea in travelers to countries where the disease is endemic and causes a major disease burden in the indigenous population, particularly children. We describe here the generation and preclinical characterization of candidate strains of ETEC which are intended to provide the basis of a live attenuated oral vaccine to prevent this disease. It has been shown previously that a spontaneously arising toxin-negative variant ETEC strain, E1392/75-2A, could confer 75% protection against challenge when administered to volunteers. Unfortunately this strain induced mild diarrhea in 15% of recipients. To eliminate the unacceptable reactogenicity of strain E1392/75-2A, it was further attenuated by introducing three different combinations of defined deletion mutations into the chromosome. A mouse intranasal model of immunization was developed and used to show that all of the strains were immunogenic. Immune responses against colonization factor antigens (CFAs) were particularly strong when the bacterial inocula were grown on “CFA agar,” which induces strong expression of these antigens. Two of the strains were selected for a phase I dose escalation safety study with healthy adult volunteers. Freshly grown organisms were harvested from CFA agar plates and administered to volunteers as a suspension containing from 5 × 107 to 5 × 109 CFU. The vaccine was well tolerated at all doses and induced significant immune responses in all recipients at the highest dose of either strain. The results provide the basis for further clinical evaluation of these vaccine candidates.

  • Copyright © 2001 American Society for Microbiology
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Construction and Characterization of Genetically Definedaro omp Mutants of Enterotoxigenic Escherichia coli and Preliminary Studies of Safety and Immunogenicity in Humans
Arthur K. Turner, Tamsin D. Terry, David A. Sack, Patricia Londoño-Arcila, Michael J. Darsley
Infection and Immunity Aug 2001, 69 (8) 4969-4979; DOI: 10.1128/IAI.69.8.4969-4979.2001

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Construction and Characterization of Genetically Definedaro omp Mutants of Enterotoxigenic Escherichia coli and Preliminary Studies of Safety and Immunogenicity in Humans
Arthur K. Turner, Tamsin D. Terry, David A. Sack, Patricia Londoño-Arcila, Michael J. Darsley
Infection and Immunity Aug 2001, 69 (8) 4969-4979; DOI: 10.1128/IAI.69.8.4969-4979.2001
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