A 6-Week Oral Toxicity Study of Oral Cholera Vaccine in Sprague-Dawley Rats

Baek, Yeong Ok; Choi, Seuk Keun; Shin, Seo Ho; Koo, Kyo Hwan; Choi, Ho Young; Cha, Seung Bum; Li, Yong Chun; Yoo, Hyeon Jeong; Lee, Joo Young; Kil, Ki Hyun; Kim, Hak Soo; Kang, Min Soo; Kang, Boo Hyun; Kim, Kap Ho; Bae, Jin Sook

Abstract

The present study was carried out to examine the toxicity and target organs of oral cholera vaccine (OCV) after repeated oral administration in Sprague-Dawley rats for 6 weeks (3 administrations, once every 2 weeks). OCV is an inactivated oral cholera vaccine that contains Vibrio cholerae and confers protection against cholera caused by V. cholera serogroups O1 (Inaba and Ogawa serotypes) and O139 (strain 4260B). The animals were orally administered either OCV placebo (negative control) or OCV at a dose equivalent to 240 times the anticipated human dose. Throughout the administration period, no significant change was detected in clinical signs, body weight, food or water consumption, urinalysis results, hematological and clinical biochemistry test results, organ weights, necropsy, or histopathological examination results. Minor changes were found in hematological and clinical biochemistry tests; however, these changes were within normal ranges. The above results suggest that oral administration of OCV in rats did not induce any toxicologically meaningful changes, and the target organs could not be determined. This study was conducted in accordance with the guidelines established by Good Laboratory Practice (2009-183, KFDA, December 22, 2009) and the OECD Principles of Good Laboratory Practice (1997).