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.
RCT Entities:
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.
Authors: Wilbur H Chen; Richard N Greenberg; Marcela F Pasetti; Sofie Livio; Michael Lock; Marc Gurwith; Myron M Levine Journal: Clin Vaccine Immunol Date: 2013-10-30
Authors: R W Kaminski; M Wu; K R Turbyfill; K Clarkson; B Tai; A L Bourgeois; L L Van De Verg; R I Walker; E V Oaks Journal: Clin Vaccine Immunol Date: 2014-01-08
Authors: Taher Uddin; Amena Aktar; Peng Xu; Russell A Johnson; M Arifur Rahman; Daniel T Leung; Sadia Afrin; Aklima Akter; Mohammad Murshid Alam; Atiqur Rahman; Fahima Chowdhury; Ashraful I Khan; Taufiqur Rahman Bhuiyan; Meagan K Bufano; Rasheduzzaman Rashu; Yanan Yu; Ying Wu-Freeman; Jason B Harris; Regina C LaRocque; Richelle C Charles; Pavol Kováč; Stephen B Calderwood; Edward T Ryan; Firdausi Qadri Journal: Am J Trop Med Hyg Date: 2014-03-31 Impact factor: 2.345
Authors: Daniel T Leung; Fahima Chowdhury; Stephen B Calderwood; Firdausi Qadri; Edward T Ryan Journal: Expert Rev Anti Infect Ther Date: 2012-04 Impact factor: 5.091