TY - JOUR
T1 - Safety and immunogenicity assessment of an oral cholera vaccine through Phase I clinical trial in Korea
AU - Baik, Young Ok
AU - Choi, Seuk Keun
AU - Kim, Jae Woo
AU - Yang, Jae Seung
AU - Kim, Ick Young
AU - Kim, Chan Wha
AU - Hong, Jang Hee
PY - 2014/4
Y1 - 2014/4
N2 - 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).
AB - 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).
KW - Immunogenicity
KW - Oral cholera vaccine
KW - Safety
KW - Vibriocidal assay, seroconversion rate
UR - http://www.scopus.com/inward/record.url?scp=84899827268&partnerID=8YFLogxK
U2 - 10.3346/jkms.2014.29.4.494
DO - 10.3346/jkms.2014.29.4.494
M3 - Article
C2 - 24753695
AN - SCOPUS:84899827268
SN - 1011-8934
VL - 29
SP - 494
EP - 501
JO - Journal of Korean medical science
JF - Journal of Korean medical science
IS - 4
ER -