title: A Randomized, Placebo-Controlled Trial Evaluating Safety and Immunogenicity of the Killed, Bivalent, Whole-Cell Oral Cholera Vaccine in Ethiopia.
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.
authors.forename: Sachin N
authors.initials: SN
authors.lastname: Desai
authors.forename: Zenebe
authors.initials: Z
authors.lastname: Akalu
authors.forename: Samuel
authors.initials: S
authors.lastname: Teshome
authors.forename: Mekonnen
authors.initials: M
authors.lastname: Teferi
authors.forename: Lawrence
authors.initials: L
authors.lastname: Yamuah
authors.forename: Deok Ryun
authors.initials: DR
authors.lastname: Kim
authors.forename: Jae Seung
authors.initials: JS
authors.lastname: Yang
authors.forename: Jemal
authors.initials: J
authors.lastname: Hussein
authors.forename: Ju Yeong
authors.initials: JY
authors.lastname: Park
authors.forename: Mi Seon
authors.initials: MS
authors.lastname: Jang
authors.forename: Chalachew
authors.initials: C
authors.lastname: Mesganaw
authors.forename: Hawult
authors.initials: H
authors.lastname: Taye
authors.forename: Demissew
authors.initials: D
authors.lastname: Beyene
authors.forename: Ahmed
authors.initials: A
authors.lastname: Bedru
authors.forename: Ajit Pal
authors.initials: AP
authors.lastname: Singh
authors.forename: Thomas F
authors.initials: TF
authors.lastname: Wierzba
authors.forename: Abraham
authors.initials: A
authors.lastname: Aseffa
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood / Q000276:immunology; D002648:Child; D002771:Cholera / Q000276:immunology / Q000517:prevention & control*; D022121:Cholera Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D004311:Double-Blind Method; D005002:Ethiopia; D005260:Female; D006801:Humans; D008297:Male; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use; D041241:Vibrio cholerae O1 / Q000276:immunology; D041242:Vibrio cholerae O139 / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D022121:Cholera Vaccines; D015164:Vaccines, Inactivated