Safety and Immunogenicity Assessment of an Oral Cholera Vaccine through Phase I Clinical Trial in Korea
Safety and Immunogenicity Assessment of an Oral Cholera Vaccine through Phase I Clinical Trial in Korea
- 주제(키워드) Oral Cholera Vaccine , Safety , Immunogenicity , Vibriocidal Assay , Seroconversion Rate
- 발행기관 대한의학회
- 발행년도 2014
- 총서유형 Journal
- UCI G704-000345.2014.29.4.003
- KCI ID ART001868106
- 본문언어 영어
초록/요약
The safety, tolerability and immunogenicity of an oral cholera vaccine (OCV) was assessedin adult Korean male through an open-label, non-comparative clinical study. Two doses ofvaccine with an interval of 2 weeks were given to 20 healthy subjects. A total of 7 adverseevents occurred in 6 subjects. However, no clinically significant change was observed inelectrocardiograms, vital signs, physical examinations, and clinical laboratory tests. Theimmunogenicity of OCV was evaluated by serum vibriocidal assay where anti-Vibriocholerae O1 and O139 antibodies were measured at day 0, 14, and 28 of vaccineadministration. 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. Inaddition, the fold increase in antibody titers ranged from 1-4,096 for O1 Inaba, 1-8,192for O1 Ogawa, and 1-384 for O139. The seroconversion rate was 95% and 45% for O1and O139 antibodies, respectively. Our study clearly shows that administration of twodoses of OCV at a 2 week-interval increases an appropriate level of antibody titer in theserum of healthy Korean adult males (Clinical Trial Number, NCT01707537).
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