A Randomized, Placebo-Controlled Trial Evaluating Safety and Immunogenicity of the Killed, Bivalent, Whole-Cell Oral Cholera Vaccine in Ethiopia

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, 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

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.

Trial registration: ClinicalTrials.gov NCT01524640.

© The American Society of Tropical Medicine and Hygiene.

Figures

Figure 1.
Figure 1.
Enrollment of participants. aOne adult lost to follow up on day 14 and one child did not provide blood at day 28. bOne adult provided blood specimen 2 days earlier at day 28 and one child received partial dose 2.

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