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A Randomized , Placebo-Controlled Trial Evaluating Safety and Immunogenicity of the Killed , Bivalent , Whole-Cell Oral Cholera Vaccine in Ethiopia . Killed whole-cell oral cholera vaccine ( OCV ) has been a key component of a comprehensive package including water and sanitation measures for recent cholera epidemics . The vaccine , given in a two-dose regimen , has been evaluated in a large number of human volunteers in India , Vietnam , and Bangladesh , where it has demonstrated safety , immunogenicity , and clinical efficacy . We conducted a double-blind randomized placebo-controlled trial in Ethiopia , where we evaluated the safety and immunogenicity of the vaccine in 216 healthy adults and children . OCV was found to be safe and elicited a robust immunological response against Vibrio cholerae O1 , with 81 % adults and 77 % children demonstrating seroconversion 14 days after the second dose of vaccine . This is the first study to evaluate safety and immunogenicity of the vaccine in a population outside Asia using a placebo-controlled , double-blind , randomized study design .
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Intervention_Control
Placebo-Controlled
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Intervention_Pharmacological
Whole-Cell Oral Cholera Vaccine
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Intervention_Pharmacological
Killed whole-cell oral cholera vaccine ( OCV )
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Intervention_Pharmacological
vaccine
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
vaccine
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Intervention_Pharmacological
OCV
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Intervention_Pharmacological
vaccine
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Intervention_Control
placebo-controlled
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Outcome_Other
safety and immunogenicity
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Outcome_Physical
safe and elicited a robust immunological response against Vibrio cholerae O1
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Outcome_Physical
seroconversion
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Participant_Condition
in Ethiopia
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Participant_Sample-size
216
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Participant_Age
adults
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Participant_Age
children .