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Korean Academy of Medical Sciences, Journal of Korean Medical Science, 4(29), p. 494, 2014

DOI: 10.3346/jkms.2014.29.4.494

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Safety and Immunogenicity Assessment of an Oral Cholera Vaccine through Phase I Clinical Trial in Korea

Journal article published in 2014 by Young Ok Baik ORCID, Seuk Keun Choi ORCID, Jae Woo Kim ORCID, Jae Seung Yang ORCID, Ick Young Kim ORCID, Chan Wha Kim, Jang Hee Hong
This paper is made freely available by the publisher.
This paper is made freely available by the publisher.

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Abstract

The safety, tolerability and immunogenicity of an oral cholera vaccine (OCV) was assessed in adult Korean male through an open-label, non-comparative clinical study. Two doses of vaccine with an interval of 2 weeks were given to 20 healthy subjects. A total of 7 adverse events occurred in 6 subjects. However, no clinically significant change was observed in electrocardiograms, vital signs, physical examinations, and clinical laboratory tests. The immunogenicity of OCV was evaluated by serum vibriocidal assay where anti-Vibrio cholerae O1 and O139 antibodies were measured at day 0, 14, and 28 of vaccine administration. The antibody titers ranged from