Oral, inactivated, whole cell enterotoxigenic Escherichia coli plus cholera toxin B subunit vaccine: results of the initial evaluation in children. PRIDE Study Group

J Infect Dis. 1999 Jan;179(1):107-14. doi: 10.1086/314543.

Abstract

Two randomized, double-blinded trials assessed the safety and immunogenicity of an oral, killed enterotoxigenic Escherichia coli (ETEC) plus cholera toxin B subunit vaccine in Egyptian children. Two doses of vaccine or E. coli K-12 were given 2 weeks apart to 105 6- to 12-year-olds and 97 2- to 5-year-olds. Safety was monitored for 3 days after each dose. Blood was collected before immunization and 7 days after each dose to measure immune responses. Few children reported postdosing symptoms, with no differences in the frequency of symptoms between treatment groups. Most vaccinees had an IgA antibody-secreting cell response against colonization factor antigen I (100%, 6-12 years; 95%, 2-5 years), coli surface antigen 2 (92%, 6-12 years; 83%, 2-5 years), and coli surface antigen 4 (93%, 6-12 years). Vaccination evoked a >/=4-fold rise in antitoxic IgA and IgG titers in 93% and 81% of children, respectively. In conclusion, the oral ETEC vaccine was safe and immunogenic in 2- to 12-year-old children, justifying further evaluation in infants.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Administration, Oral
  • Age Factors
  • Antibodies, Bacterial / blood
  • Bacterial Vaccines / administration & dosage*
  • Bacterial Vaccines / adverse effects
  • Bacterial Vaccines / immunology
  • Child
  • Child, Preschool
  • Cholera Toxin / administration & dosage
  • Cholera Toxin / adverse effects
  • Cholera Toxin / immunology
  • Cohort Studies
  • Double-Blind Method
  • Egypt
  • Escherichia coli / immunology*
  • Escherichia coli Infections / prevention & control
  • Escherichia coli Vaccines
  • Female
  • Humans
  • Immunoglobulin A / blood
  • Immunoglobulin G / blood
  • Male
  • Safety
  • Time Factors
  • Vaccines, Conjugate / administration & dosage
  • Vaccines, Conjugate / adverse effects
  • Vaccines, Conjugate / immunology
  • Vaccines, Inactivated / administration & dosage
  • Vaccines, Inactivated / adverse effects
  • Vaccines, Inactivated / immunology

Substances

  • Antibodies, Bacterial
  • Bacterial Vaccines
  • Escherichia coli Vaccines
  • Immunoglobulin A
  • Immunoglobulin G
  • Vaccines, Conjugate
  • Vaccines, Inactivated
  • Cholera Toxin