References
- 국립보건 안전연구원 고시 제 94-3호 의약품등의 독성 시험 기준 국립 보건 안전연구원
- Immunology (3rd Ed) Ivan,R.;Jonathan,B.;David,M.
A study on antigenicity of HRccine (formalin inactivated HFRS virus vaccine) was investigated in guinea pigs and mice. As a part of the safety evaluation of the HRccine, antigenicity tests were carried out according to the Estabilish Regulations of National Institute of Safety Research. In active systemic anaphylaxis (ASA) test no sign was detected when sensitized with up to 120 clinical dose and challenged with up to 1200 clinical dose in guinea pigs. In passive systemic anaphylaxis test guinea pigs showed no sign. In passive cutaneous anaphylaxis (PCA) test, HRccine specific IgE antibody was not detected when sensitized and challenged with up to 1200 clinical dose. Conclusively, there was no adverse antigenic potential at the clinical dose of 120 clinical dose alone and 120 clinical dose with Al(OH)3.