TY - JOUR
T1 - 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
AU - Saha, Amit
AU - Chowdhury, Mohiul Islam
AU - Khanam, Farhana
AU - Bhuiyan, Md Saruar
AU - Chowdhury, Fahima
AU - Khan, Ashraful Islam
AU - Khan, Iqbal Ansary
AU - Clemens, John
AU - Ali, Mohammad
AU - Cravioto, Alejandro
AU - Qadri, Firdausi
N1 - Funding Information:
Funding: This work was funded by the Bill and Melinda Gates Foundation (Grant no. OPP50419 ).
Copyright:
Copyright 2012 Elsevier B.V., All rights reserved.
PY - 2011/10/26
Y1 - 2011/10/26
N2 - 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.
AB - 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.
KW - Bangladeshi adults and children
KW - Immunogenicity
KW - Oral cholera vaccine
KW - Safety
KW - Shanchol
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U2 - 10.1016/j.vaccine.2011.08.108
DO - 10.1016/j.vaccine.2011.08.108
M3 - Article
C2 - 21907255
AN - SCOPUS:80053950117
SN - 0264-410X
VL - 29
SP - 8285
EP - 8292
JO - Vaccine
JF - Vaccine
IS - 46
ER -