title: Safety and immunogenicity of Escherichia coli O157 O-specific polysaccharide conjugate vaccine in 2-5-year-old children.
abstract: BACKGROUND
  Escherichia coli O157:H7 causes severe enteritis and hemolytic-uremic syndrome, mostly in young children and older adults. Similar to the case with Shigella, serum IgG against the O-specific polysaccharide of E. coli O157:H7 may confer immunity by lysing the inoculum in the intestine. A phase 1 trial in adults showed that a vaccine of E. coli O157:H7 O-specific polysaccharide conjugated to recombinant exotoxin A of Pseudomonas aeruginosa (O157-rEPA) was safe and immunogenic.
  
  
  METHODS
  A phase 2 trial of the O157-rEPA vaccine was conducted in 49 children 2-5 years old who were divided randomly into groups receiving 1 or 2 doses of vaccine. Adverse reactions were monitored. Serum IgG lipopolysaccharide (LPS) antibodies were determined.
  
  
  RESULTS
  No significant adverse reactions were observed. At 1 week after the first dose was administered, most children (81%) responded with a >4-fold increase in serum IgG LPS antibodies. At 6 weeks after the first dose was administered, all children responded with a >8-fold increase; a second dose did not elicit a booster response. At 26 weeks after the first dose was administered, the geometric mean titer of serum IgG LPS antibodies was ~20-fold higher than was the prevaccination titer. These serum samples had high titers of bactericidal activity that were correlated roughly with serum IgG LPS antibody titers (r = .78).
  
  
  CONCLUSIONS
  The O157-rEPA vaccine was safe and immunogenic in young children. A phase 3 trial of the administration of this conjugate vaccine concurrently with routine immunization in infants is planned.
authors.affiliation: Carolinas Medical Center, Charlotte, North Carolina, USA.
authors.forename: Amina
authors.initials: A
authors.lastname: Ahmed
authors.forename: Jianpin
authors.initials: J
authors.lastname: Li
authors.forename: Yossi
authors.initials: Y
authors.lastname: Shiloach
authors.forename: John B
authors.initials: JB
authors.lastname: Robbins
authors.forename: Shousun C
authors.initials: SC
authors.lastname: Szu
mesh_terms: D000907:Antibodies, Bacterial / Q000032:analysis / Q000276:immunology; D001428:Bacterial Vaccines / Q000009:adverse effects* / Q000276:immunology; D002675:Child, Preschool; D004927:Escherichia coli Infections / Q000517:prevention & control*; D019453:Escherichia coli O157 / Q000737:chemistry*; D006801:Humans; D007074:Immunoglobulin G / Q000032:analysis / Q000276:immunology; D019081:O Antigens / Q000008:administration & dosage* / Q000276:immunology; D018074:Vaccines, Conjugate / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*
chemical_list: D000907:Antibodies, Bacterial; D001428:Bacterial Vaccines; D007074:Immunoglobulin G; D019081:O Antigens; D018074:Vaccines, Conjugate