Peru-15, a Live Attenuated Oral Cholera Vaccine, Is Safe and Immunogenic in Bangladeshi Toddlers and Infants

Vaccine. 2007 Jan 4;25(2):231-8. doi: 10.1016/j.vaccine.2006.08.031. Epub 2006 Sep 5.

Abstract

A live oral Vibrio cholerae O1 El Tor vaccine, Peru-15 was tested in a double-blind, randomized placebo controlled study for safety and immunogenicity in Phase I and Phase II studies in 240 Bangladeshi children aged 9 months-5 years of age. Two different doses (2x10(7) and 2x10(8)cfu) were tested. Vaccination did not elicit adverse events and the strain was genetically stable. Vibriocidal antibody responses developed in 42/50 (84%) toddlers (2-5 years) and 35/50 (70%) of younger children (9-23 months) and overall 77/100 (77%) who received the high dose. LPS-IgA-antibody responses were seen in 60% of toddlers and 34% of infants; 40% responded with IgA antibodies to cholera toxin. The responses to the reduced dose was lower. These studies demonstrate that Peru-15 at a dose of 2x10(8)cfu is safe and immunogenic in children in Bangladesh.

Publication types

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

MeSH terms

  • Administration, Oral
  • Antibodies, Viral / blood
  • Child, Preschool
  • Cholera Vaccines / adverse effects
  • Cholera Vaccines / immunology*
  • Double-Blind Method
  • Female
  • Humans
  • Immunoglobulin A / blood
  • Infant
  • Lipopolysaccharides / immunology
  • Male
  • Vaccines, Attenuated / immunology

Substances

  • Antibodies, Viral
  • Cholera Vaccines
  • Immunoglobulin A
  • Lipopolysaccharides
  • Peru 15
  • Vaccines, Attenuated