CJ-50005 (A형 간염백신)에 대한 유전독성시험

Mutagenicity Tests on CJ-50005 (Hepatitis A Vaccine)

  • 김종호 (제일제당 종합기술원 제약연구소) ;
  • 이은영 (제일제당 종합기술원 제약연구소) ;
  • 김달현 (제일제당 종합기술원 제약연구소) ;
  • 김현석 (제일제당 종합기술원 제약연구소)
  • 발행 : 2001.10.01

초록

CJ-50005 is an inactivated whole virus vaccine derived from hepatitis A virus (HM175) grown in human MRC-5 diploid fibroblasts cell culture. In order to evaluate the mutagenic potential of CJ-50005, : 3 sets of mutagenicity tests were performed. In the reverse mutation test wing Salmonella typhimurium TA1535, TA1 537, TA98, TA100 and TA102, CJ-50005 did not increase the number of revertants at any concentration tested in this study (2.8, 1.4, 0.7, 0.35 and 0.175 $\mu\textrm{g}$/plate). CJ-50005, at concentration of 2.8, 1.4 and 0.7 $\mu\textrm{g}$/ml, did not increase the number of cells having structural or numerical chromosome aberration in cytogenic test using Chinese Hamster Lung cells. In mouse micronucleus test, no significant increase in the occurrence of micronucleated polychromatic erythrocytes was observed in ICR male and female mice intraperitoneally administered with CJ-50005 at the doses of 25, 12.5 and 6.25 $\mu\textrm{g}$/kg. These results indicate that CJ-50005 has no mutagenic potential in these in vitro and in vivo system.

키워드

참고문헌

  1. JAMA v.264 Risk factors for acute non-A, non-B hepatitis in the united states and association with hepatitis C. Alter, M. J.;Hadler, S. C.;Judson, F. N.
  2. Assays for the detection of chemically induced chromosome damage in cultured mammalian cells in Mutagenicith Testing Dean, B. J.;Danford, N.;Venitt, S.;Parr, J. M.
  3. N. Engl. J. Med. v.302 Hepatitis A in day-care centers; a communitywide assessment. Hadler, S. C.;Webster, H. M.;Erben, J. J.;Swanson, J. E.;Maynard, J. E.
  4. J. Toxicol. Pub. Health v.15 Mutagenicity tests on CJ-50003 (Japandese Encephalitis Vaccine). Jae-Ku Kang;Jong-Ho Kim;Dal-Hyun Kim;Sang-Beom Moon;Soo-Ok Kim;Young-Soo Lee
  5. JAMA v.212 Viral hepatitis; new light on an old desease. Krugman, S.;Giles, J. P.
  6. Am. J. Epidemiol. v.122 Frequency of illness associated with epidemic hepatitis A virus infection in adults. Lender, W. M.;Lemon, S. M.;Kirkpatrick, J. W.;Redifield, R. R.;Fields, M. L.;Kelley, P. W.
  7. Murat Res. v.113 Revised Methods for the Salmonella mutagenicity test. Maron, D. M;Ames, B. M.
  8. MMWR. v.48 no.RR-12 Prevention of hepatitis A through active or passive immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP)
  9. Mutat. Res. v.31 The micronucleus test Schmid, W.
  10. Korean J. Immunol. v.22 Immunogenicity of a combined hepatitis A and B vaccine in ICR mice Young-Ju Chung;Hyun-Seok KIm;Sung-Hee Lee
  11. J. Tocicol. Pub. Health v.15 CJ-50002 (비브리오 백신)에 대한 변이원성시험 강재구;이성학;김달현;이나경;박완제;이영수
  12. 의약품 등의 독성시험 기준 (식품의 약품안정청 고시 제 1998-56호) 식품의약품안전청