• Biomolecules & Therapeutics
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• v.7 no.4
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• pp.390-396
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• 1999

CJ-50005 is a hepatitis A vaccine which is prepared by formalin inactivation of the HM175 virus cultured in human diploid MRC-5 cells. The general pharmacological properties of CJ-50005 were evaluated in various animals and in vitor system. CJ-50005 at the doses of 0.025, 0.25 and 0.75 $\mu\textrm{g}$/kg, i.m. had no effect on general behavior in mice, chemo- and electro-convulsions in mice, writhing syndrome induced by acetic acid in mice, the barbital sleeping time in mice, body temperature in rats, charcoal meal propulsion in mice and urine and electrolytes excretion in rats. In anesthetized dogs, CJ-50005(0.25 and 0.75 $\mu\textrm{g}$/kg, i.v) did not alter the respiratory rate, blood pressure, heart rate, femoral blood flow and ECG. In in vitro experiment, CJ-50005 at the concentration up to 0.02 $\mu\textrm{g}$/ml did not produce any changes in the contractions of the isolated ileum of guinea pigs caused by acetylcholine, histamine or $BaCl_2$. Since these pharmacological effects of CJ-50005 were observed at dose much greater than those in clinical use (approximately 0.025 $\mu\textrm{g}$/kg, i.m.), it is likely that this vaccine may be relatively free of undesirable effects in clinical practice.

• Toxicological Research
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• v.17 no.3
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• pp.235-239
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• 2001

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.

• Toxicological Research
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• v.17 no.4
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• pp.297-301
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• 2001

The acute toxicity of CJ-50005, an inactivated whole virus vaccine derived from hepatitis A virus (HM175) grown in human MRC-5 diploid fibroblast culture, was tested in Sprague Dawley (SD) rats and beagle dogs. CJ-50005 was orally and intramuscularly administered up to the maximum dose of 81$\mu\textrm{g}$/kg. as much as 3,000 times of the expected clinical dose, in SD rats and was intramuscularly administered up to 27 $\mu\textrm{g}$/kg, as much as 1,000 times of the expected clinical dose, in beagle dogs. In these experiments, there were no death and clinical changes which were related to CJ-50005 administration. In addition, there were no significant changes between control and treated groups in body weights and autopsy findings. In conclusion, the administration of CJ-50005 over 81$\mu\textrm{g}$/kg in SD rats and over 27$\mu\textrm{g}$/kg in beagle dogs was proved to be safe, and it is thought that CJ-50005 may not show any toxicity in its clinical use.