Safety and immunogenicity of an oral, inactivated enterotoxigenic Escherichia coli plus cholera toxin B subunit vaccine in Bangladeshi adults and children

Vaccine. 2000 Jun 1;18(24):2704-12. doi: 10.1016/s0264-410x(00)00056-6.


We have compared the B cell responses evoked in Bangladeshi, adults (n=11, median age 25 years) and children (n=21, median age 4.5 years), 7 days after intake of each of two doses of an oral, inactivated enterotoxigenic Escherichia coli (ETEC) vaccine composed of formalin-killed ETEC strains expressing the colonization factors, CFA/I, CFA/II and CFA/IV together with 1 mg of recombinant cholera toxin B-subunit (rCTB). The vaccine was well tolerated and only gave rise to negligible side effects. Peak antibody-secreting cell (ASC) response of the IgA isotype were seen 7 days after the first dose of the vaccine. The ASC responses to the different colonization factors (CFs) increased from a 29- to 46-fold (responder frequency 90-100%) in the adults and 13- to 24-fold (responder frequency 67-90%) in the children. The IgA-ASC response to rCTB also peaked after the first dose in the adults (426-fold, responder frequency 100%) and the children (46-fold, responder frequency 95%). Increased IgA antibody levels against CFA/I as well as IgA and IgG antibody levels to rCTB were seen in plasma after immunisation. About 86% of the children and 80% of the adults responded with faecal antibodies to rCTB, whereas about 67% of both groups responded to CFA/I. These results show that a single dose of the ETEC vaccine may elicit significant mucosal immune responses in both children and adults residing in an ETEC-endemic country such as Bangladesh.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antibodies, Bacterial / biosynthesis
  • Bacterial Vaccines / immunology*
  • Bangladesh
  • Child
  • Child, Preschool
  • Cholera Toxin / immunology*
  • Cholera Vaccines / immunology*
  • Drug Evaluation
  • Enterotoxins
  • Escherichia coli / immunology*
  • Female
  • Humans
  • Immunoglobulin A / biosynthesis
  • Male
  • Vaccines, Conjugate / immunology


  • Antibodies, Bacterial
  • Bacterial Vaccines
  • Cholera Vaccines
  • Enterotoxins
  • Immunoglobulin A
  • Vaccines, Conjugate
  • Cholera Toxin