[Evaluation on the safety and efficacy of lyophilized purified human rabies vaccine (CTN-Vero-RV)].
| Autor: | Chen W; Wuhan Institute of Biological Products, Wuhan 430060, China., Zheng XX, Zhang LM, Zheng JS, Zhang LH, Liao XZ, Hong KQ, Zhu YT, Deng HF, Zheng XL, Yang XM, Huang ZL, Li J, Sun W, Xu GL |
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| Jazyk: | čínština |
| Zdroj: | Zhonghua liu xing bing xue za zhi = Zhonghua liuxingbingxue zazhi [Zhonghua Liu Xing Bing Xue Za Zhi] 2009 Dec; Vol. 30 (12), pp. 1261-4. |
| Abstrakt: | Objective: To observe the safety and efficacy of lyophilized purified human rabies vaccine CTN-Vero RV, CTN strain produced in Vero cells. Methods: 450 healthy volunteers were divided into two groups, with 300 of them receiving CTN-Vero-RV (rabies vaccine for human use made in Vero cells with CTN strain) while 150 of them receiving PVRV to serve as control group. All the subjects were immunized on days 0, 3, 7, 14 and 28 at deltoid muscle respectively. Local and systemic reactions were observed and sera were collected for neutralizing antibody testing using RFFIT. 365 and 730 days after the first dose, sera from the 212 and 176 subjects of the studied group while 97 and 80 subjects from the control group were collected to test for neutralizing antibody. Results: No severe local or systemic reactions were observed after immunization was performed in the two groups. On days 3, 7, 14, 28 and 365 after the first dose, the antibody positive rates appeared to be 2.35%, 80.78%, 100.00%, 100.00%, 98.58% and 73.30% in the study group and 4.00%, 87.20%, 100.00%, 100.00%, 97.94% and 76.25% in the controls respectively. On day 0, 3, 7, 14, 28, 365 and 730, GMT of the neutralizing antibody level were 0.12, 1.01, 9.83, 12.61, 3.68 and 2.81 IU/ml in the study group while 0.13, 1.18, 10.24, 11.61, 4.18 and 1.92 IU/ml were seen in the control group respectively. There were no significant differences in both antibody positive rates and GMT between the two groups on days 3, 7, 14, 28, 365 or 730 (P > 0.05). Conclusion: CTN-Vero-RV was safe and effective as well as could generate a persistent immune response. |
| Databáze: | MEDLINE |
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