Safety and immunogenicity study of a killed bivalent (O1 and O139) whole-cell oral cholera vaccine Shanchol, in Bangladeshi adults and children as young as 1 year of age

Amit Saha, Mohiul Islam Chowdhury, Farhana Khanam, Md Saruar Bhuiyan, Fahima Chowdhury, Ashraful Islam Khan, Iqbal Ansary Khan, John Clemens, Mohammad Ali, Alejandro Cravioto, Firdausi Qadri

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Safety and immunogenicity study of an oral, killed, bivalent whole-cell, cholera vaccine, Shanchol was carried out in Bangladeshi participants. This study was conducted prior to initiating a feasibility study in Bangladesh. Study participants: The double-blind, randomized placebo controlled study was carried out in adults (18-45 years), toddlers (2-5 years) and younger children (12-23 months). Two doses of the vaccine/placebo were given 14 days apart. Results: Shanchol did not elicit major adverse events in any age group. Vibriocidal antibody responses in adults were 60% against Vibrio cholerae O1 Inaba, 72% against V. cholerae O1 Ogawa and 21% against V. cholerae O139. In toddlers, responses were 84%, 75% and 64% and in younger children it was 74%, 78% and 54% against Inaba, Ogawa and O139 serotypes. The responses in all ages were higher in vaccinees compared to pre-immune titers or to responses in placebo recipients (P<0.001).Plasma IgA antibody response to O1 Inaba LPS was seen in 61%, 73% and 45% of adults, toddlers and younger children, respectively. Conclusions: The safety and immunogenicity data for Shanchol is promising and warrants future use in large scale trial in cholera endemic areas, high risk Bangladeshi population and in other countries in the region.

Original languageEnglish (US)
Pages (from-to)8285-8292
Number of pages8
JournalVaccine
Volume29
Issue number46
DOIs
StatePublished - Oct 26 2011

Keywords

  • Bangladeshi adults and children
  • Immunogenicity
  • Oral cholera vaccine
  • Safety
  • Shanchol

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

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