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Laboratory Techniques Used to Maintain and Differentiate Biotypes of Vibrio cholerae Clinical and Environmental Isolates
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Laboratory Techniques Used to Maintain and Differentiate Biotypes of Vibrio cholerae Clinical and Environmental Isolates

Published on: May 30, 2017

Development of Peru-15 (CholeraGarde), a live-attenuated oral cholera vaccine: 1991-2009

Mohiul Islam Chowdhury1, Alaullah Sheikh, Firdausi Qadri

  • 1International Centre for Diarrhoeal Disease Research, Bangladesh, GPO Box 128, Mohakhali, Dhaka, 1000, Bangladesh. mohiul@icddrb.org

Expert Review of Vaccines
|December 1, 2009
PubMed

Insights

CholeraGarde, a live oral cholera vaccine, shows promise for preventing severe dehydrating cholera in all age groups. Ongoing studies aim to confirm its efficacy and develop a single-dose vaccine for widespread use.

Area of Science:

  • Vaccinology
  • Infectious Diseases
  • Public Health

Background:

  • Increasing global incidence of severe dehydrating cholera, particularly in resource-limited settings.
  • Cholera poses a significant risk to individuals of all ages, including infants.
  • Extensive research over three decades has focused on developing safe and effective oral cholera vaccines.

Purpose of the Study:

  • To review the development of CholeraGarde, a live-attenuated Vibrio cholerae O1 vaccine candidate.
  • To assess the safety and immunogenicity of CholeraGarde in various populations.
  • To outline ongoing and planned clinical trials for CholeraGarde.

Main Methods:

  • Development of CholeraGarde (Peru-15) from a Vibrio cholerae O1 strain (El Tor biotype, Inaba serotype).
  • Clinical testing in over 500 individuals (adults, children, infants) across different geographical settings (USA, Bangladesh).
  • Evaluation of safety, immunogenicity, and strain excretion at different dosages and in diverse age groups.

Main Results:

  • CholeraGarde demonstrated a favorable safety and immunogenicity profile in adults, children, and infants.
  • A single dose of 10(8) CFU was found to be safe and immunogenic in 9-month-old infants.
  • Strain excretion varied, being higher in US adults and lower in Bangladeshi participants across all age groups.

Conclusions:

  • CholeraGarde is a promising live-attenuated oral cholera vaccine candidate with a good safety and immunogenicity profile.
  • Ongoing Phase II studies are evaluating its co-administration with other vaccines in endemic areas and its safety in HIV-positive individuals.
  • Phase III trials are planned to determine protective efficacy and support the development of a single-dose vaccine for broad protection against cholera.

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