R.J. Phillpotts , M.J. Welch , P.H. Ridgeway , A.C. Walkland , J. Melling
{"title":"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","authors":"R.J. Phillpotts , M.J. Welch , P.H. Ridgeway , A.C. Walkland , J. Melling","doi":"10.1016/0092-1157(88)90038-8","DOIUrl":null,"url":null,"abstract":"<div><p>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 (<em>P</em> < 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.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"16 2","pages":"Pages 109-118"},"PeriodicalIF":0.0000,"publicationDate":"1988-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(88)90038-8","citationCount":"14","resultStr":"{\"title\":\"A test for the relative potency of herpes simplex virus vaccines based upon the female guinea-pig model of HSV 2 genital infection\",\"authors\":\"R.J. Phillpotts , M.J. Welch , P.H. Ridgeway , A.C. Walkland , J. Melling\",\"doi\":\"10.1016/0092-1157(88)90038-8\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p>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 (<em>P</em> < 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.</p></div>\",\"PeriodicalId\":75991,\"journal\":{\"name\":\"Journal of biological standardization\",\"volume\":\"16 2\",\"pages\":\"Pages 109-118\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"1988-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1016/0092-1157(88)90038-8\",\"citationCount\":\"14\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of biological standardization\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/0092115788900388\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of biological standardization","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/0092115788900388","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
A test for the relative potency of herpes simplex virus vaccines based upon the female guinea-pig model of HSV 2 genital infection
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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