Investigational Vaccine for Escherichia coli O157: Phase 1 Study of O157 O-Specific Polysaccharide-Pseudomonas aeruginosa Recombinant Exoprotein A Conjugates in Adults

Escherichia coli O157 causes severe enteritis and the extraintestinal complication hemolyticuremic syndrome. Serum IgG against the surface polysaccharide antigen, the O-specific polysaccharide of lipopolysaccharide (LPS), may confer protective immunity by lysing the inocula. In a phase 1 clinical st...

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Bibliographic Details
Published in:The Journal of infectious diseases 1998-02, Vol.177 (2), p.383-387
Main Authors: Konadu, Edward Y., Parke, James C., Tran, Hung T., Bryla, Dolores A., Robbins, John B., Szu, Shousun C.
Format: Article
Language:English
Subjects:
Adolescent
ADP Ribose Transferases
Adult
Antibodies
Antibodies, Bacterial - analysis
Antibodies, Bacterial - immunology
Bacterial Toxins
Bacteriology
Biological and medical sciences
Escherichia coli
Escherichia coli Infections - prevention & control
Escherichia coli O157 - genetics
Escherichia coli O157 - immunology
Exotoxins - genetics
Exotoxins - immunology
Female
Fundamental and applied biological sciences. Psychology
Hemolytic uremic syndrome
Humans
Immunity
Immunoglobulin G - analysis
Immunoglobulin G - immunology
Immunoglobulin M - analysis
Immunoglobulin M - immunology
Infections
Lipopolysaccharides
Major Articles
Male
Microbiology
O Antigens - immunology
Pseudomonas aeruginosa - genetics
Pseudomonas aeruginosa - immunology
Pseudomonas aeruginosa Exotoxin A
Recombinant Fusion Proteins - immunology
Shiga toxins
Shigella
Vaccination
Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies
Vaccines, Conjugate - adverse effects
Vaccines, Conjugate - immunology
Virulence Factors
Volunteerism
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Summary:Escherichia coli O157 causes severe enteritis and the extraintestinal complication hemolyticuremic syndrome. Serum IgG against the surface polysaccharide antigen, the O-specific polysaccharide of lipopolysaccharide (LPS), may confer protective immunity by lysing the inocula. In a phase 1 clinical study, three investigational vaccines were studied in 87 healthy adults. The vaccines were prepared by covalently binding E. coli O157 O-specific polysaccharide with Pseudomonas aeruginosa recombinant exoprotein A. No significant reactions were reported. Most volunteers (81%) responded with a >4-fold increase in IgG LPS antibodies 1 week after vaccination; all volunteers responded with a >4-fold rise at 4 weeks and this level was sustained for 26 weeks after injection. All three vaccines elicited high titers of serum bactericidal activity that roughly correlated with the serum IgG and IgM LPS antibody levels. A phase 2 study in young children is planned.
ISSN:0022-1899
1537-6613
DOI:10.1086/514203