Long-term toxicity test of oral hexavalent reassortant live attenuated rotavirus vaccine(Vero cell) in SD rats
10.13200/j.cnki.cjb.004670
- VernacularTitle:口服六价重配轮状病毒减毒活疫苗（Vero细胞）在SD大鼠体内的长期毒性试验
- Author:
Chunfang LUAN
1
Author Information
1. Sinovac (Dalian) Vaccine of Technology Co., Ltd., Dalian 116620, Liaoning Province, China
- Publication Type:Journal Article
- Keywords:
Oral hexavalent reassortant live attenuated rotavirus vaccine(Vero cell);
Long-term toxicity test;
SD rats;
Safety evaluation
- From:
Chinese Journal of Biologicals
2026;39(03):257-263
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo evaluate the long-term toxicity of oral hexavalent reassortant live attenuated rotavirus(RV)vaccine(Vero cell) in SD rats, so as to provide theoretical basis for the clinical application of the vaccine.MethodsA total of 150 SPF healthy rats with a male-to-female ratio of 1∶1 were selected and divided into experimental groups and satellite groups, 120 rats in experimental groups and 30 rats in satellite groups. The experimental groups included high-dose group[oral hexavalent reassortant live attenuated rotavirus vaccine(Vero cell), 2 doses/rat], low-dose group [oral hexavalent reassortant live attenuated rotavirus vaccine(Vero cell), 1 dose/rat], negative control group(0. 9% sodium chloride, 4 mL/rat)and vector control group(vector control, 4 mL/rat), with 30 rats in each group, and the rats were administered by gavage, once every 2 weeks, for a total of 4 doses. The clinical characterization of the rats was observed, and the weight, body temperature,ophthalmologic examination, clinical pathology(blood count, coagulation function, blood biochemistry and urinalysis), virus absorption, tissue distribution, gross autopsy, weighing of major organs, and histopathological examination were performed.The satellite groups randomly divided 30 rats into high-dose, low-dose, and negative control groups, with the same dosage as the experimental groups, for immunological parameter assessment and virus shedding studies.ResultsThere were no regular changes with toxicological significance in clinical characterization, body weight, body temperature, ophthalmic examination,hematology, coagulation function, blood biochemistry, urinalysis and other indicators in each group. The RV-specific IgA antibodies could be detected in rats of both high-dose and low-dose groups, and the highest antibody titer reached 1∶80. No administration-related changes were observed in organ weights and organ coefficients of rats in each group, and no administration-related systemic toxicity pathological changes were found in histopathological examination.ConclusionNo systemic toxicity was observed in the repeated dose toxicity test, and the no observed adverse effect level(NOAEL) dose was considered to be 2 doses/rat.
