A Randomized,Placebo-Controlled Trial Evaluating Safety and Immunogenicity of the Killed,Bivalent, Whole-Cell Oral Cholera Vaccine in Ethiopia |
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| Authors: | Sachin N. Desai Zenebe Akalu Samuel Teshome Mekonnen Teferi Lawrence Yamuah Deok Ryun Kim Jae Seung Yang Jemal Hussein Ju Yeong Park Mi Seon Jang Chalachew Mesganaw Hawult Taye Demissew Beyene Ahmed Bedru Ajit Pal Singh Thomas F. Wierzba Abraham Aseffa |
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| Affiliation: | International Vaccine Institute, Seoul, Korea; Armauer Hansen Research Institute, Addis Ababa, Ethiopia |
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| Abstract: | 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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