A test for the relative potency of herpes simplex virus vaccines based upon the female guinea-pig model of HSV 2 genital infection

Journal of biological standardization Pub Date : 1988-01-01 DOI:10.1016/0092-1157(88)90038-8

R.J. Phillpotts , M.J. Welch , P.H. Ridgeway , A.C. Walkland , J. Melling

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引用次数: 14

Abstract

An ELISA for total herpes simplex virus (HSV) 1 antigen content and a test of immunogenicity based upon the female guinea-pig model of HSV 2 genital infection were applied to two samples from batches of HSV 1 subunit (‘Skinner’) vaccine. The ELISA was reproducible within an approximately threefold limit of error and batches 1 and 2 were indistinguishable in antigen content. The effects of vaccination in the guinea-pig model were assessed by a statistical analysis of scores derived from the principal clinical signs, vaginal oedema and lesions on the external genitalia. The statistical power of the guinea-pig assay was such that reductions in the severity of illness approaching 40% would be significant (P < 0·05) on 90% of occasions. The ability to make quantitative estimates of immunogenicity will prove useful in the quality control of HSV vaccine batches which are destined for clinical trials in man.

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基于HSV 2型雌性豚鼠生殖器感染模型的单纯疱疹病毒疫苗相对效力测试

采用ELISA法测定单纯疱疹病毒(HSV) 1抗原总含量和基于雌性豚鼠HSV 2生殖器感染模型的免疫原性试验，对两批HSV 1亚单位(“斯金纳”)疫苗样品进行了免疫原性检测。该酶联免疫吸附试验可在大约三倍的误差范围内重现，第1批和第2批的抗原含量无法区分。通过对主要临床症状、阴道水肿和外生殖器病变的评分进行统计分析，评估了豚鼠模型中疫苗接种的效果。豚鼠试验的统计能力是这样的，疾病严重程度降低接近40%将是显著的(P <在90%的情况下为0.05)。对免疫原性进行定量估计的能力将证明对用于人体临床试验的HSV疫苗批次的质量控制是有用的。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Journal of biological standardization

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