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A randomized, non-inferiority trial comparing two bivalent killed, whole cell, oral cholera vaccines (Euvichol vs Shanchol) in the Philippines

Authors
Baik, Yeong OkChoi, Seuk KeunOlveda, Remigio M.Espos, Roberto A.Ligsay, Antonio D.Montellano, May B.Yeam, Jong SunYang, Jae SeungPark, Ju YeonKim, Deok RyunDesai, Sachin N.Singh, Ajit PalKim, Ick YoungKim, Chan WhaPark, Sue-nie
Issue Date
17-11월-2015
Publisher
ELSEVIER SCI LTD
Keywords
Oral cholera vaccine; Safety; Immunogenicity; Euvichol; Shanchol; Children; Adults
Citation
VACCINE, v.33, no.46, pp.6360 - 6365
Indexed
SCIE
SCOPUS
Journal Title
VACCINE
Volume
33
Number
46
Start Page
6360
End Page
6365
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/91887
DOI
10.1016/j.vaccine.2015.08.075
ISSN
0264-410X
Abstract
Background: Currently, there are two oral cholera vaccines (OCV) that are prequalified by the World Health Organization. Both (Dukoral and Shanchol) have been proven to be safe, immunogenic, and effective. As the global supply of OCV remains limited, we assessed the safety and immunogenicity of a new low cost, killed, bivalent OCV (Euvichol) in the Philippines. Methods: The randomized controlled trial was carried out in healthy Filipino adults and children. Two doses of either the current WHO prequalified OCV (Shanchol) or the same composition OCV being considered for WHO prequalification (Euvichol) were administered to participants. Results: The pivotal study was conducted in total of 1263 healthy participants (777 adults and 486 children). No serious adverse reactions were elicited in either vaccine groups. Vibriocidal antibody responses to V. cholerae O1 Inaba following administration of two doses of Euvichol were non-inferior to those of Shanchol in adults (82% vs 76%) and children (87% vs 89%). Similar findings were observed for O1 Ogawa in adults (80% vs 74%) and children (91% vs 88%). Conclusion: A two dose schedule with Euvichol induces a strong vibriocidal response comparable to those elicited by the currently WHO prequalified OCV, Shanchol. Euvichol will be an oral cholera vaccine suitable for use in lower income countries, where cholera still has a significant economic and public health impact. (C) 2015 Elsevier Ltd. All rights reserved.
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