title: Safety and immunogenicity assessment of an oral cholera vaccine through phase I clinical trial in Korea.
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 < 2.5-5,120 for V. cholerae O1 Inaba, < 2.5-10,240 for V. cholerae O1 Ogawa and < 2.5-480 for V. cholerae O139. In addition, the fold increase in antibody titers ranged from 1-4,096 for O1 Inaba, 1-8,192 for O1 Ogawa, and 1-384 for O139. The seroconversion rate was 95% and 45% for O1 and O139 antibodies, respectively. Our study clearly shows that administration of two doses of OCV at a 2 week-interval increases an appropriate level of antibody titer in the serum of healthy Korean adult males (Clinical Trial Number, NCT01707537).
authors.affiliation: Department of Biotechnology, Korea University and EuBiologics Co., Ltd., Chuncheon, Korea.
authors.forename: Young Ok
authors.identifier: 0000-0001-9935-9264
authors.initials: YO
authors.lastname: Baik
authors.affiliation: Department of Biotechnology, Korea University and EuBiologics Co., Ltd., Chuncheon, Korea.
authors.forename: Seuk Keun
authors.identifier: 0000-0001-7483-1980
authors.initials: SK
authors.lastname: Choi
authors.affiliation: Department of Pharmacology and Clinical Trials Center, Chungnam National University, College of Medicine and Hospital, Daejeon, Korea.
authors.forename: Jae Woo
authors.identifier: 0000-0002-3511-9330
authors.initials: JW
authors.lastname: Kim
authors.affiliation: Clinical Immunology Section, International Vaccine Institute (IVI), Seoul, Korea.
authors.forename: Jae Seung
authors.identifier: 0000-0003-1243-5610
authors.initials: JS
authors.lastname: Yang
authors.affiliation: Department of Biotechnology, Korea University, Seoul, Korea.
authors.forename: Ick Young
authors.identifier: 0000-0002-5572-7667
authors.initials: IY
authors.lastname: Kim
authors.affiliation: Department of Biotechnology, Korea University, Seoul, Korea.
authors.forename: Chan Wha
authors.identifier: 0000-0002-1019-1832
authors.initials: CW
authors.lastname: Kim
authors.affiliation: Department of Pharmacology and Clinical Trials Center, Chungnam National University, College of Medicine and Hospital, Daejeon, Korea.
authors.forename: Jang Hee
authors.identifier: 0000-0002-0623-5455
authors.initials: JH
authors.lastname: Hong
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood* / Q000276:immunology; D000917:Antibody Formation; D002771:Cholera / Q000517:prevention & control*; D022121:Cholera Vaccines / Q000009:adverse effects / Q000276:immunology*; D003402:Creatine Kinase / Q000097:blood; D006801:Humans; D008297:Male; D056910:Republic of Korea; D014098:Toothache / Q000209:etiology; D041241:Vibrio cholerae O1 / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D022121:Cholera Vaccines; D003402:Creatine Kinase
keywords: Immunogenicity; Oral Cholera Vaccine; Safety; Vibriocidal Assay, Seroconversion Rate
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