Safety, Immunogenicity, and Transmissibility of Single-Dose Live Oral Cholera Vaccine Strain CVD 103-HgR in 24- To 59-month-old Indonesian Children

J Infect Dis. 1993 Nov;168(5):1169-76. doi: 10.1093/infdis/168.5.1169.

Abstract

Recombinant A-B+ Vibrio cholerae O1 strain CVD 103-HgR is a safe, highly immunogenic, single-dose live oral vaccine in adults in industrialized countries. Safety, excretion, immunogenicity, vaccine transmissibility, and environmental introduction of CVD 103-HgR were investigated among 24- to 59-month-old children in Jakarta. In 81 households, 1 child was randomly allocated a single dose of vaccine (5 x 10(9) cfu) and another, placebo. Additionally, 139 unpaired children were randomly allocated vaccine or placebo. During 9 days of follow-up, diarrhea or vomiting did not occur more often among vaccines than controls. Vaccine was minimally excreted and was isolated from no controls and from 1 (0.6%) of 177 unvaccinated family contacts. A 4-fold or higher rise in serum vibriocidal antibody was observed in 75% of vaccines (10-fold rise in geometric mean titer over baseline). Of 135 paired placebo recipients or household contacts, 5 had vibriocidal seroconversions. Moore swabs placed in sewers and latrines near 97 households failed to detect vaccine. These observations pave the way for a large-scale field trial of efficacy.

Publication types

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

MeSH terms

  • Antibodies, Bacterial / blood
  • Antibody Formation
  • Child, Preschool
  • Cholera / prevention & control*
  • Cholera / transmission
  • Cholera Vaccines / therapeutic use*
  • Feces / microbiology
  • Humans
  • Immunoglobulin G / blood
  • Indonesia
  • Safety
  • Urban Population
  • Vaccination* / adverse effects
  • Vaccines, Attenuated / therapeutic use
  • Vaccines, Synthetic / therapeutic use

Substances

  • Antibodies, Bacterial
  • Cholera Vaccines
  • Immunoglobulin G
  • Vaccines, Attenuated
  • Vaccines, Synthetic