Kulkarni P S, Raut Sidram K, Jadhav Suresh S, Kapre Subhash V, Deuskar Nileema
Serum Institute of India Ltd, Pune, India.
Hum Vaccin. 2007 Sep-Oct;3(5):183-6. doi: 10.4161/hv.3.5.4360. Epub 2007 Apr 30.
Pre-exposure prophylaxis was given to employees supposed to be involved in rabies vaccine production in India. Prior to availability of the manufacturer's own human diploid cell (HDC) vaccine (Rabivax), immunization was executed with a chick embryo cell (CEC) vaccine (Rabipur). This constellation gave an opportunity to compare retrospectively immunogenicity of these two vaccines. The data was collected by retrospective analysis over more than three years at the clinic of Serum Institute of India Ltd. As per the standard protocol, persons with negative rabies vaccination history receive a dose of 1 ml of rabies vaccine intramuscularly on day 0, 7 and 28, and the virus anti-glycoprotein antibodies are measured one month after the third dose. The antibody levels > or =0.5 IU/ml are considered protective. The CEC and HDC vaccines were used during the analysis period. In all, 43 individuals received the CEC vaccine, 106 the HDC vaccine. The mean age of recipients was 33 years five months (Rabipur) and 30 years three months (Rabivax). All subjects in both groups were males. Five commercial batches of the CEC vaccine (129 doses) and seven batches of the HDC vaccine (318 doses) were used. Ninety-nine percent of the HDC and 93% of the CEC vaccine recipients were protected after the standard three dose schedule. Geometric mean titre was significantly greater for the HDC than CEC vaccine, being 5.05 IU/ml and 2.90 IU/ml, respectively (p = 0.0002). The HDC vaccine showed a good lot-to-lot consistency with respect to GMT both by ANOVA test and Nonparametric ANOVA test. On the other hand, the CEC vaccine demonstrated a variation in titres, when the lots were compared. Three out of four low-responders accepted a booster vaccination, and regardless of whether Rabipur or Rabivax was used, all three responded well one month after the booster. The Indian HDC vaccine compares well with the CEC vaccine in terms of immunogenicity. With HDC vaccines, cost has been an issue. However, since the new HDC vaccine has a comparable cost to the CEC vaccine, it may be possible to use it in large-scale vaccinations.
印度对预计参与狂犬病疫苗生产的员工进行了暴露前预防。在制造商自己的人二倍体细胞（HDC）疫苗（Rabivax）上市之前，使用鸡胚细胞（CEC）疫苗（Rabipur）进行免疫接种。这种情况提供了一个回顾性比较这两种疫苗免疫原性的机会。数据是通过对印度血清研究所有限公司诊所三年多的回顾性分析收集的。按照标准方案，狂犬病疫苗接种史阴性的人在第0、7和28天肌肉注射1毫升狂犬病疫苗，在第三剂疫苗接种后一个月测量病毒抗糖蛋白抗体。抗体水平≥0.5 IU/ml被认为具有保护性。在分析期间使用了CEC疫苗和HDC疫苗。共有43人接种了CEC疫苗，106人接种了HDC疫苗。接种者的平均年龄分别为33岁5个月（Rabipur）和30岁3个月（Rabivax）。两组的所有受试者均为男性。使用了5个商业批次的CEC疫苗（129剂）和7个批次的HDC疫苗（318剂）。在标准的三剂接种方案后，99%的HDC疫苗接种者和93%的CEC疫苗接种者受到了保护。HDC疫苗的几何平均滴度显著高于CEC疫苗，分别为5.05 IU/ml和2.90 IU/ml（p = 0.0002）。通过方差分析测试和非参数方差分析测试，HDC疫苗在批次间的GMT方面表现出良好的一致性。另一方面，比较各批次时，CEC疫苗的滴度存在差异。四名低应答者中有三人接受了加强接种，无论使用的是Rabipur还是Rabivax，三人在加强接种后一个月均反应良好。印度的HDC疫苗在免疫原性方面与CEC疫苗相当。对于HDC疫苗来说，成本一直是个问题。然而，由于新的HDC疫苗成本与CEC疫苗相当，有可能在大规模疫苗接种中使用。
