title: 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.
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.
  
  
  METHODS
  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.
authors: International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.
authors: Amit
authors: A
authors: Saha
authors: Mohiul Islam
authors: MI
authors: Chowdhury
authors: Farhana
authors: F
authors: Khanam
authors: Md Saruar
authors: MS
authors: Bhuiyan
authors: Fahima
authors: F
authors: Chowdhury
authors: Ashraful Islam
authors: AI
authors: Khan
authors: Iqbal Ansary
authors: IA
authors: Khan
authors: John
authors: J
authors: Clemens
authors: Mohammad
authors: M
authors: Ali
authors: Alejandro
authors: A
authors: Cravioto
authors: Firdausi
authors: F
authors: Qadri
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D001459:Bangladesh; D002675:Child, Preschool; D002771:Cholera / Q000517:prevention & control*; D022121:Cholera Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007117:Immunization, Secondary / Q000379:methods; D007070:Immunoglobulin A / Q000097:blood; D007223:Infant; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D014611:Vaccination / Q000379:methods; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000276:immunology; D041241:Vibrio cholerae O1 / Q000276:immunology*; D041242:Vibrio cholerae O139 / Q000276:immunology*; D055815:Young Adult
chemical_list: D000907:Antibodies, Bacterial; D022121:Cholera Vaccines; D007070:Immunoglobulin A; D010919:Placebos; D015164:Vaccines, Inactivated