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与美国国立卫生研究院(NIH)和哈贝尔试验相比,采用抗体结合试验对灭活狂犬病疫苗进行效价检测(作者译)

[Potency testing of inactivated rabies vaccines with the antibody binding test in comparison with the NIH and habel test(author's transl)].

作者信息

Oei H L, Krauss H

出版信息

Zentralbl Bakteriol Orig A. 1975;231(1-3):1-14.

PMID:1154901
Abstract

The Antibody Binding Test, a new technique for the evaluation of inactivated Rabies vaccines, developed by Arko, Wiktor and Sikes, was compared with the NIH- and Habel Test. Various vaccines were tested with these methods with the following results and conclusions. 1. The Habel Test was useful for testing of Hempt vaccines. With highly potent vaccines however it was not possible to get exact protection values, for all vaccinated mice were protected against all virus dilutions. 2. The NIH Test seemed to have an advantage over the Habel Test, since animals are vaccinated only twice, instead of 6 times, within two weeks. But this test was less suitable for the evaluation of Hempt vaccines. The requested Antigenic Value was reached only rarely with these vaccines. Repeated, NIH Tests gave widely differing results with Hempt vaccines. Vaccines which passed the NIH Test also passed the Habel Test, but not always vice versa. Antigenic Values of highly potent vaccines could be determined exactly with the NIH Test. This method is much better standardized by using a Standard vaccine in the test. The NIH Test is preferable for inactivated Rabies vaccines, with the exception of vaccines containing brain tissue, like the Hempt vaccine. 3. The Antibody Binding Test is a useful technique for the examination of inactivated cell culture vaccines. Consistent results can be achieved by skilled and experienced laboratory personnel. To avoid irregularities in the mortality rates, at least 10 mice should be used for each dilution of vaccine. With this method only Rabies virus antigen is measured which is bound by serum antibody during an incubation period of 60 min. Other factors supporting immunization like adjuvant- or booster-effects are not evaluated. Compared with the Habel and NIH Test the Antibody Binding Test is the best method for the evaluation of the amount of antigen in a Rabies vaccine. Hempt vaccines reached - as they did in the NIH Test - only Antigenic Values in this test. Vaccines with an Antigenic Value of larger than or equal to 0,3 in the Antibody Binding Test gave positive results also in the Habel and NIH Test, Vaccines with a Protection Value of 10-3 in the Habel Test and an Antigenic Value of 0,3 in the NIH Test did not always reach an Antigenic Value of 0.3 in the Antibody Binding Test.

摘要

由阿尔科、维克托和赛克斯开发的抗体结合试验是一种评估灭活狂犬病疫苗的新技术,该技术与美国国立卫生研究院(NIH)试验和哈贝尔试验进行了比较。使用这些方法对各种疫苗进行了测试,结果和结论如下:1. 哈贝尔试验适用于测试亨普特疫苗。然而,对于高效疫苗,无法获得准确的保护值,因为所有接种疫苗的小鼠都能抵抗所有病毒稀释液。2. NIH试验似乎比哈贝尔试验更具优势,因为在两周内动物只需接种两次,而不是6次。但该试验不太适合评估亨普特疫苗。使用这些疫苗很少能达到要求的抗原值。重复进行的NIH试验对亨普特疫苗给出的结果差异很大。通过NIH试验的疫苗也通过了哈贝尔试验,但并非总是反之亦然。高效疫苗的抗原值可以通过NIH试验准确测定。通过在试验中使用标准疫苗,该方法的标准化程度更高。除了含有脑组织的疫苗(如亨普特疫苗)外,NIH试验更适用于灭活狂犬病疫苗。3. 抗体结合试验是检测灭活细胞培养疫苗的一种有用技术。熟练且经验丰富的实验室人员可以获得一致的结果。为避免死亡率出现异常,每种疫苗稀释液至少应使用10只小鼠。使用这种方法仅测量狂犬病病毒抗原,其在60分钟的孵育期内与血清抗体结合。其他支持免疫的因素,如佐剂或加强效应,未进行评估。与哈贝尔试验和NIH试验相比,抗体结合试验是评估狂犬病疫苗中抗原量的最佳方法。亨普特疫苗在该试验中——与在NIH试验中一样——仅达到抗原值。在抗体结合试验中抗原值大于或等于0.3的疫苗在哈贝尔试验和NIH试验中也给出阳性结果,在哈贝尔试验中保护值为10-3且在NIH试验中抗原值为0.3的疫苗在抗体结合试验中并不总是能达到0.3的抗原值。

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