Field trial of oral cholera vaccines in Bangladesh: results from three-year follow-up

Lancet. 1990 Feb 3;335(8684):270-3. doi: 10.1016/0140-6736(90)90080-o.

Abstract

The protective efficacy (PE) of B subunit killed whole-cell (BS-WC) and killed whole-cell-only (WC) oral cholera vaccines was assessed in a randomised double-blind field trial among children aged 2-15 years and women over 15 years in rural Bangladesh. Among the 62 285 subjects who received three doses of BS-WC, WC, or Escherichia coli K12 strain placebo, cumulative PE at 3 years of follow-up was 50% for BS-WC and 52% for WC. PE was similar against severe and non-severe cholera, but was significantly lower in children who were vaccinated at 2-5 years (26% for BS-WC; 23% for WC) than in older persons (63% for BS-WC; 68% for WC). Among persons vaccinated at 2-5 years, protection at 4-6 months of follow-up was similar to that for older persons, but rapidly waned thereafter and was not evident during the third year of follow-up. In contrast, persons vaccinated at older ages were protected even in the third year of follow-up (PE 40% for BS-WC; 62% for WC). PE was substantially higher against classical cholera (58% for BS-WC; 60% for WC) than against El Tor cholera (39% and 40%).

Publication types

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

MeSH terms

  • Administration, Oral
  • Adolescent
  • Age Factors
  • Bangladesh / epidemiology
  • Chi-Square Distribution
  • Child
  • Child, Preschool
  • Cholera / classification
  • Cholera / epidemiology
  • Cholera / immunology
  • Cholera / prevention & control*
  • Cholera Vaccines / administration & dosage
  • Cholera Vaccines / adverse effects
  • Cholera Vaccines / classification
  • Cholera Vaccines / immunology*
  • Double-Blind Method
  • Drug Evaluation
  • Female
  • Follow-Up Studies
  • Humans
  • Incidence
  • Randomized Controlled Trials as Topic
  • Time Factors
  • Vaccines, Inactivated / administration & dosage
  • Vaccines, Inactivated / adverse effects
  • Vaccines, Inactivated / classification
  • Vaccines, Inactivated / immunology*

Substances

  • Cholera Vaccines
  • Vaccines, Inactivated