Zhang Xiaowei, Zhu Zhenggang, Wang Chuanlin
Emergency Department, Peking University People's Hospital, No. 11 Xizhimen South Street, Beijing, China.
Clin Vaccine Immunol. 2011 Sep;18(9):1477-9. doi: 10.1128/CVI.05090-11. Epub 2011 Jul 13.
This study was done to investigate the antibody response to a Vero cell antirabies vaccine, the persistence of antibody for 5 years, and the effect of a booster dose after this interval. From August 2005 to February 2011, a total of 195 patients were enrolled into our study due to an animal bite. The Essen intramuscular (i.m.) regimen, which is recommended by the WHO for modern vaccines used in postexposure treatment, was adopted in this study. Blood samples were obtained on day 0, day 7, day 14, day 45, year 1, year 2, year 3, year 4, year 5, and year 5 plus 14 days. Immunogenicity was evaluated by the titration of neutralizing antibodies with a rapid fluorescent focus inhibition test (RFFIT). Seroconversion was expressed as the seroconversion rate (SCR). A secondary quantitative evaluation criterion, other than the seroconversion level, was the geometric mean titer (GMT). Of the 195 enrolled patients, 168 (86.4%) of them completed the whole study. No serious adverse reactions to the vaccine were reported during vaccination, the 5-year follow-up period, or revaccination. On day 14, the rabies antibody GMT value was 8.87 IU/ml in the vaccinees. During the next 5 years, the SCR in the ChengDa vaccine group gradually decreased to 34.0% at year 5, down from 90.5% at year 1. There was a significant booster effect: the GMT was 15.22 IU/ml on year 5 plus 14 days. Our findings demonstrate that the ChengDa rabies vaccine offers an alternative with a high degree of efficacy and yet limited side effects and ensures that the exposed patient will be on the safe side of the risk of rabies by the 14th day. Moreover, when followed by a booster dose 5 years later, it could boost the immunity. A further booster is effective in inducing a good neutralizing antibody response even after an interval of 5 years.
本研究旨在调查对Vero细胞狂犬病疫苗的抗体反应、抗体5年的持续情况以及在此间隔后加强剂量的效果。2005年8月至2011年2月,共有195例因动物咬伤而纳入我们研究的患者。本研究采用了世界卫生组织推荐用于暴露后治疗的现代疫苗的埃森肌内注射方案。在第0天、第7天、第14天、第45天、第1年、第2年、第3年、第4年、第5年以及第5年加14天采集血样。通过快速荧光灶抑制试验(RFFIT)滴定中和抗体来评估免疫原性。血清转化以血清转化率(SCR)表示。除血清转化水平外,另一个定量评估标准是几何平均滴度(GMT)。在195例纳入研究的患者中,168例(86.4%)完成了整个研究。在疫苗接种期间、5年随访期或再次接种期间,均未报告对疫苗的严重不良反应。在第14天,疫苗接种者的狂犬病抗体GMT值为8.87 IU/ml。在接下来的5年中,成大疫苗组的SCR从第1年的90.5%逐渐降至第5年的34.0%。有显著的加强效果:在第5年加14天时GMT为15.22 IU/ml。我们的研究结果表明,成大狂犬病疫苗提供了一种疗效高且副作用有限的替代方案,并确保暴露患者在第14天时处于狂犬病风险的安全范围内。此外,5年后进行加强剂量接种可增强免疫力。即使间隔5年后,再次加强也能有效诱导良好的中和抗体反应。