J Korean Med Sci.  2014 Apr;29(4):494-501. 10.3346/jkms.2014.29.4.494.

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

• Baik YO
• Choi SK
• Kim JW
• Yang JS
• Kim IY
• Kim CW
• Hong JH

• KMID: 1774453
• DOI: http://doi.org/10.3346/jkms.2014.29.4.494

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).

Keyword

Oral Cholera Vaccine; Safety; Immunogenicity; Vibriocidal Assay, Seroconversion Rate

MeSH Terms

Administration, Oral
Adult
Antibodies, Bacterial/*blood/immunology
Antibody Formation
Cholera/*prevention & control
Cholera Vaccines/adverse effects/*immunology
Creatine Kinase/blood
Humans
Male
Republic of Korea
Toothache/etiology
Vibrio cholerae O1/immunology
Antibodies, Bacterial
Cholera Vaccines
Creatine Kinase