Safety and Immunogenicity Assessment of an Oral Cholera Vaccine through Phase I Clinical Trial in Korea.
10.3346/jkms.2014.29.4.494
- Author:
Young Ok BAIK
1
;
Seuk Keun CHOI
;
Jae Woo KIM
;
Jae Seung YANG
;
Ick Young KIM
;
Chan Wha KIM
;
Jang Hee HONG
Author Information
1. EuBiologics Co., Ltd., Chuncheon, Korea.
- Publication Type:Original Article ; Clinical Trial, Phase I ; Research Support, Non-U.S. Gov't
- Keywords:
Oral Cholera Vaccine;
Safety;
Immunogenicity;
Vibriocidal Assay, Seroconversion Rate
- MeSH:
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
- From:Journal of Korean Medical Science
2014;29(4):494-501
- CountryRepublic of Korea
- Language:English
-
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).
