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

10 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 Jan 1

Fingerprint

Cholera Vaccines
Clinical Trials, Phase I
Korea
Vibrio cholerae O1
Safety
Vibrio cholerae O139
Antibodies
Vaccines
Vital Signs
Serum
Physical Examination
Healthy Volunteers
Electrocardiography
Clinical Trials

Keywords

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

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Safety and immunogenicity assessment of an oral cholera vaccine through Phase I clinical trial in Korea. / Baik, Young Ok; Choi, Seuk Keun; Kim, Jae Woo; Yang, Jae Seung; Kim, Ick Young; Kim, Chan Wha; Hong, Jang Hee.

In: Journal of Korean Medical Science, Vol. 29, No. 4, 01.01.2014, p. 494-501.

Research output: Contribution to journalArticle

Baik, Young Ok ; Choi, Seuk Keun ; Kim, Jae Woo ; Yang, Jae Seung ; Kim, Ick Young ; Kim, Chan Wha ; Hong, Jang Hee. / Safety and immunogenicity assessment of an oral cholera vaccine through Phase I clinical trial in Korea. In: Journal of Korean Medical Science. 2014 ; Vol. 29, No. 4. pp. 494-501.
@article{3350e6ca2b304e6392379421a81d6239,
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).",
keywords = "Immunogenicity, Oral cholera vaccine, Safety, Vibriocidal assay, seroconversion rate",
author = "Baik, {Young Ok} and Choi, {Seuk Keun} and Kim, {Jae Woo} and Yang, {Jae Seung} and Kim, {Ick Young} and Kim, {Chan Wha} and Hong, {Jang Hee}",
year = "2014",
month = "1",
day = "1",
doi = "10.3346/jkms.2014.29.4.494",
language = "English",
volume = "29",
pages = "494--501",
journal = "Journal of Korean Medical Science",
issn = "1011-8934",
publisher = "Korean Academy of Medical Science",
number = "4",

}

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 - 2014/1/1

Y1 - 2014/1/1

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

UR - http://www.scopus.com/inward/citedby.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

VL - 29

SP - 494

EP - 501

JO - Journal of Korean Medical Science

JF - Journal of Korean Medical Science

SN - 1011-8934

IS - 4

ER -