Acute toxicity investigation of recombinant trivalent human papillomavirus vaccine
10.7501/j.issn.1674-6376.2017.07.010
- VernacularTitle:重组三价人乳头瘤病毒疫苗的急性毒性研究
- Author:
bing Xiao ZHOU
1
;
Fei YIN
;
Chao WANG
;
jun Ya WANG
;
Di ZHANG
;
Xue WANG
;
Yan HUO
;
Lan XU
;
ping Jian CHEN
;
Bo YONG-JIANG
;
LI LIU
Author Information
1. 中国食品药品检定研究院国家药物安全评价监测中心
- Keywords:
human papillomavirus;
recombinant vaccine;
cervical cancer;
acute toxicity
- From:
Drug Evaluation Research
2017;40(7):935-937
- CountryChina
- Language:Chinese
-
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.
