Safety and immunogenicity assessment of an oral cholera vaccine through Phase I clinical trial in Korea

Young Ok Baik, Seuk Keun Choi, Jae Woo Kim, Jae Seung Yang, Ick Young Kim, Chan Wha Kim, Jang Hee Hong

Research output: Contribution to journalArticle

12 Citations (Scopus)

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).

Original languageEnglish
Pages (from-to)494-501
Number of pages8
JournalJournal of Korean medical science
Volume29
Issue number4
DOIs
Publication statusPublished - 2014 Apr

Keywords

  • Immunogenicity
  • Oral cholera vaccine
  • Safety
  • Vibriocidal assay, seroconversion rate

ASJC Scopus subject areas

  • Medicine(all)

Fingerprint Dive into the research topics of 'Safety and immunogenicity assessment of an oral cholera vaccine through Phase I clinical trial in Korea'. Together they form a unique fingerprint.

  • Cite this