Cai Y.,Chengdu Kanghua Biological Products Co. |
Zhou R.,Chengdu Kanghua Biological Products Co. |
Li S.-Y.,Chengdu Kanghua Biological Products Co. |
Chen H.-G.,Chengdu Kanghua Biological Products Co. |
And 9 more authors.
Chinese Journal of Biologicals | Year: 2015
Objective: To observe the safety and immunogenicity of domestic freeze-dried rabies vaccine (human diploid cells, HDCs) for human use, shorten as HDCV. Methods: The residents at ages of 10 ∼ 60 years in Lianshui County, Huai an City, Jiangsu Province, China, at high risk of rabies virus infection, were divided into trial and control groups, 600 for each. The subjects in trial group were immunized i.m. with domestic freeze-dried HDCV according to Essen schedule on days 0, 3, 7, 14 and 28 respectively, while those in control group with imported freeze-dried rabies vaccine for human use (Vero cells). All the subjects were observed for immediate reaction for 30 min, and for local and systemic reactions 6, 24, 48 and 72 h after immunization. Serum samples were collected before and 7, 14, 42 d after immunization, and determined for neutralizing antibody by rapid fluorescent focus inhibition test (KFFIT), based on which the positive conversion rate and GMT of antibody were calculated. Results: All the adverse reactions in subjects were mild and disappeared within 72 h, while no reactions of grade IIIor above were observed. The total incidence rates of local reactions in trial and control groups were 7. 67% and 6. 83% respectively, while those of systemic reactions were both 5. 00%, which showed no significant difference (P > 0. 05). The antibody positive conversion rates in trial group 7, 14 and 42 d after the first dose were 28. 77%, 100% and 100%, while those in control group were 28. 72%, 98. 96% and 100%, respectively, which showed no significant difference (P > 0. 05). However, the GMTs of antibody in trial group 7, 14 and 42 d after the first dose were 0. 274 8, 19. 744 3 and 37. 575 0 IU/ml, while those in control group were 0. 247 4, 17. 327 4 and 37. 723 1 IU/ml, respectively, which showed no significant difference (P> 0. 05). Conclusion: Domestic freeze-dried HDCV for human use induced mild adverse reactions and showed good immunogenicity.