A Randomized, Placebo-Controlled Trial Evaluating Safety and Immunogenicity of the Killed, Bivalent, Whole-Cell Oral Cholera Vaccine in Ethiopia
| Autor: | Ajit Pal Singh, Thomas F. Wierzba, Mekonnen Teferi, Ju Yeong Park, Jemal Hussein, Demissew Beyene, Hawult Taye, Sachin N. Desai, Deok Ryun Kim, Samuel Teshome, Mi Seon Jang, Zenebe Akalu, Jae Seung Yang, Abraham Aseffa, Chalachew Mesganaw, Ahmed Bedru, Lawrence Yamuah |
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| Rok vydání: | 2014 |
| Předmět: |
Adult
Male medicine.medical_specialty Population Placebo-controlled study Administration Oral Vibrio cholerae O139 law.invention Randomized controlled trial Cholera Double-Blind Method law Virology Internal medicine medicine Humans Seroconversion education Child education.field_of_study business.industry Immunogenicity Vibrio cholerae O1 Cholera Vaccines Articles medicine.disease Antibodies Bacterial Regimen Infectious Diseases Vaccines Inactivated Immunology Parasitology Female Ethiopia Cholera vaccine business |
| Zdroj: | The American Journal of Tropical Medicine and Hygiene |
| ISSN: | 1476-1645 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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