Acute toxicity investigation of recombinant trivalent human papillomavirus vaccine / 药物评价研究

ABSTRACT

objective To evaluate the acute toxicity of recombinant trivalent human papillomavirus (HPV) vaccines.Methods Wistar rats were randomly divided into negative control and HPV groups with 20 rats in each group.Rats in HPV groups were sc administered with a single-dose of 1.5 mL of HPV vaccines (three times of human dose/each rat),while rats in negative control group were given equal volume of saline.The clinical state of animals was observed,and the body mass changes were detected.Rats were dissected after 15 d of treatment and examined by gross pathology.Results Following a single injection with high-dose HPV vaccines,there were not obvious abnormalities in clinical symptom.Compared with negative control group,the body weight of rats from HPV vaccines-treated group had no significant difference.No obvious macro-pathological change was found in all animals.Conclusion Single sc injection with recombinant trivalent HPV vaccines is well tolerated and no obvious toxicological change is found in Wistar rats.These results will facilitate further preclinical safety studies of HPV vaccines.