Oscar de Souza Lopes , Suely S.D. de Almeida Guimarães , Ricardo de Carvalho
{"title":"Studies on yellow fever vaccine II—stability of the reconstituted product","authors":"Oscar de Souza Lopes , Suely S.D. de Almeida Guimarães , Ricardo de Carvalho","doi":"10.1016/0092-1157(88)90033-9","DOIUrl":"10.1016/0092-1157(88)90033-9","url":null,"abstract":"<div><p>This work evaluated the stability of diluted yellow fever vaccine in order to determine conditions that maintain the minimum of 3 log<sub>10</sub> of 17D virus per human dose as required by WHO. The vaccines were held at 0 °C or at 37 °C and were diluted either with distilled water, with 0·15 <span>m</span> saline or with 0·15 <span>m</span> PBS at pH 5·5, 7·2 and 8·0. In a next step, stabilizer substances such as gelatin and peptone were added to the vaccines. Dilution of the vaccines in distilled water maintained the virus titre for up to three hours at 37 °C and this diluent has been adopted for routine use in Brazil.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"16 2","pages":"Pages 71-76"},"PeriodicalIF":0.0,"publicationDate":"1988-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(88)90033-9","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14498137","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Dépistage de la leucose bovine enzootique par le test elisa appliqué au lactoserum concentré de tank","authors":"P. Prevost , M. Eloit , B. Toma","doi":"10.1016/0092-1157(88)90036-4","DOIUrl":"https://doi.org/10.1016/0092-1157(88)90036-4","url":null,"abstract":"<div><p>Une méthode de concentration des immunoglobulines du lactosérum par précipitation au sulfate d'ammonium a été appliquée à des laits de tank dans le cadre du dépistage de la leucose bovine enzootique à l'aide du test ELISA. L'étude du lait de 122 étables indemnes a montré que la spécificité de la technique ELISA n'était pas modifiée. La sensibilité du test est améliorée. Ainsi, parmi 44 étables infectées, toutes les exploitations de taux d'infection supérieur à 4% et les <span><math><mtext>3</mtext><mtext>4</mtext></math></span> de celles de taux d'infection compris entre 1 et 4% ont été dépistées. Facile à mettre en oeuvre et peu coûteuse, la concentration du lactosérum se révèle intéressante pour le dépistage de l'infection des exploitations par le virus de la leucose bovine enzootique, en particulier pour les étables de plus de 40 vaches laitières.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"16 2","pages":"Pages 91-97"},"PeriodicalIF":0.0,"publicationDate":"1988-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(88)90036-4","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72292149","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"WHO international reference reagents for human proinsulin and human insulin C-peptide","authors":"A.F. Bristow , R.E.Gaines Das","doi":"10.1016/0092-1157(88)90005-4","DOIUrl":"10.1016/0092-1157(88)90005-4","url":null,"abstract":"<div><p>Candidate preparations for international reference reagents for immunoassays of human proinsulin and human insulin C-peptide were evaluated in an international collaborative study. With the authorization of the Expert Committee on Biological Standardization of WHO, the following preparations were established as international reference reagents: human proinsulin (84/611, nominal ampoule content 6 μg) and human insulin C-peptide (84/510, 10 μg). Each preparation is intended as a primary reference reagent for the calibration of immunoassays.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"16 3","pages":"Pages 179-186"},"PeriodicalIF":0.0,"publicationDate":"1988-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(88)90005-4","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14300043","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Determination of the epinephrine-refractory hypoglycaemic activity of whole-cell pertussis vaccine in mice","authors":"Y. Horiuchi , T. Iida","doi":"10.1016/0092-1157(88)90011-X","DOIUrl":"10.1016/0092-1157(88)90011-X","url":null,"abstract":"<div><p>A new assay method has been developed for the quantitative estimation of the inhibitory effect of pertussis vaccine on epinephrine-induced hyperglycaemia in mice. The statistical analysis of the assay was based on logarithm-transformed estimates of the blood glucose levels. The method was sufficiently sensitive to detect the activity of 0·004 millilitre of commercial combined diphtheria-tetanus-whole cell pertussis vaccine. The estimated common variance was as small as 0·0034 and the assay was highly reproducible. Among commercial vaccines there was a significant difference in activity. The activity of a stock pertussis vaccine was inactivated by 5 m<span>m</span> glutaraldehyde at 37 °C for 30 min, but resisted treatment with 40 m<span>m</span> formaldehyde at 37 °C for 5 days. The extent of inactivation with the chemicals was calculated by a parallel line assay as the activity relative to that of untreated control pertussis vaccine.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"16 4","pages":"Pages 239-248"},"PeriodicalIF":0.0,"publicationDate":"1988-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(88)90011-X","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14274223","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Interference between strains in live virus vaccines II: combined vaccination with varicella and measles-mumps-rubella vaccine","authors":"Rosemarie Berger , Max Just","doi":"10.1016/0092-1157(88)90015-7","DOIUrl":"10.1016/0092-1157(88)90015-7","url":null,"abstract":"<div><p>A combined vaccine against varicella and measles-mumps-rubella made by mixing two commercially available products (Varilrix and Pluserix SK-RIT) has proved to be only partially successful in early trials. Although the seroconversion rates with the MMR components were comparable with those usually achieved, the varicella take was depressed to 77%. A new low dose measles-mumps-rubella vaccine was prepared in which the measles virus content was reduced to <span><math><mtext>1</mtext><mtext>5</mtext></math></span> and the mumps virus content to <span><math><mtext>1</mtext><mtext>8</mtext></math></span>. Commercial varicella vaccine was added to the low dose MMR vaccine. The seroconversion rates for measles was 98·2%, for mumps 100%, for rubella 99·4% and for varicella 98%. This product seemed to be well balanced in respect of a possible interference between the four different virus vaccine strains.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"16 4","pages":"Pages 275-279"},"PeriodicalIF":0.0,"publicationDate":"1988-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(88)90015-7","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13985505","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jean Nyabenda , Erwin Bautens , Martine Borremans , Roger Verhofstadt , Maurice Weckx , André Marchal
{"title":"The production of mycobacterial antigens by homogeneous culture in a fermentor","authors":"Jean Nyabenda , Erwin Bautens , Martine Borremans , Roger Verhofstadt , Maurice Weckx , André Marchal","doi":"10.1016/0092-1157(88)90013-3","DOIUrl":"10.1016/0092-1157(88)90013-3","url":null,"abstract":"<div><p><em>Mycobacterium bovis</em> strain BCG, substrain 1173P2, has been grown in homogeneous culture in classical synthetic Sauton medium without supplementary ingredients. The culture conditions are described. The protein release in the culture medium and the tuberculin yield after 2% trichloroacetic acid precipitation were significantly improved. The antigenicity of the tuberculin has been successfully assayed on specifically sensitized guinea-pigs. It is concluded that homogeneous mycobacterium culture in a fermentor using synthetic medium is a suitable method for the large scale production of antigen.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"16 4","pages":"Pages 259-267"},"PeriodicalIF":0.0,"publicationDate":"1988-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(88)90013-3","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14190624","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"World Health Organization International Standards for highly purified human, porcine and bovine insulins","authors":"A.F. Bristow , R.E.Gaines Das , D.R. Bangham","doi":"10.1016/0092-1157(88)90004-2","DOIUrl":"10.1016/0092-1157(88)90004-2","url":null,"abstract":"<div><p>The 4th International Standard (IS) for Insulin, established in 1958, consists of a mixture of relatively impure bovine and porcine insulins and is not suitable as a standard for the assay of highly purified single-species insulins presently used in the treatment of diabetes. Preparations of human, bovine and porcine crystalline insulins, representative of current highly purified therapeutic insulins, have now been studied in an international collaborative study carried out by twenty-three laboratories in fifteen countries. In the collaborative study described here, each of the three preparations was found to be suitable for use as a standard for insulin for bioassay and each was established by WHO in 1986 as an international standard. The 4th IS of Insulin bovine/porcine (code numbered 58/6) has been discontinued. Insulin preparations should now be calibrated in terms of International Units defined by the standard for the appropriate species: the International Standard for Insulin, Human, the International Standard for Insulin, Bovine, or the International Standard for Insulin, Porcine.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"16 3","pages":"Pages 165-178"},"PeriodicalIF":0.0,"publicationDate":"1988-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(88)90004-2","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14181332","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The stability and immunogenicity of a dispersed-grown freeze-dried pasteur BCG vaccine","authors":"M. Gheorghiu , P.H. Lagrange , C. Fillastre","doi":"10.1016/0092-1157(88)90025-X","DOIUrl":"10.1016/0092-1157(88)90025-X","url":null,"abstract":"<div><p>The level of antituberculous immunity seems to be related to the number of memory T cells induced. This may vary as a function of the multiplication and persistence of BCG in host tissues. The most important requirements for a BCG vaccine are, therefore, the immunogenicity of the strain, the high proportion of live to dead bacilli, and adequate dispersion and low levels of soluble antigens. The surface-grown Pasteur BCG vaccine contains a very high proportion of bacilli killed by ball-milling and freeze-drying. It also contains clumps and soluble antigens, all factors influencing cell-mediated immune processes and viability control. Therefore, several batches of vaccine were prepared on an industrial scale using one of the most immunogenic strains (French 1173 P2) and grown as dispersed bacilli by a modified cell type culture method. This method provided fully viable, well-dispersed vaccines which have a viability and heat stability superior to that of the classical surface-grown BCG. The immunogenicity was checked by multiplication and persistence in mouse organs and the skin reactivity and tuberculin hypersensitivity in guinea-pigs showed results comparable to those obtained with classical vaccine. Small-scale tests in children showed superior immunogenicity of the dispersed as opposed to the classical vaccine and there was no suppurative adenitis.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"16 1","pages":"Pages 15-18, IN1, 19-26"},"PeriodicalIF":0.0,"publicationDate":"1988-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(88)90025-X","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14477780","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Development of a mouse model to estimate the potency of the diphtheria toxoid component of diphtheria-tetanus and diphtheria-tetanus-pertussis vaccines","authors":"S.C. Maheshwari , Suniti B. Sharma , Subhash Ahuja , S.N. Saxena","doi":"10.1016/0092-1157(88)90001-7","DOIUrl":"10.1016/0092-1157(88)90001-7","url":null,"abstract":"<div><p>A mouse model to estimate the potency of the diphtheria toxoid component in diphtheriatetanus vaccines and diphtheria-tetanus-pertussis vaccines has been developed as an alternative to the conventional method of testing in guinea-pigs. Optimal conditions with regard to dose, route and period of immunization have been standardized. The maximum levels of antitoxin were detected five weeks after vaccination and the s.c. route was found to be optimal. Potency data have been compared with other studies in mouse models and with those obtained by the conventional method in guinea-pigs.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"16 3","pages":"Pages 139-146"},"PeriodicalIF":0.0,"publicationDate":"1988-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(88)90001-7","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14300041","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Interference between strains in live virus vaccines I: combined vaccination with measles, mumps and rubella vaccine","authors":"Rosemarie Berger , Max Just , Reinhard Glück","doi":"10.1016/0092-1157(88)90014-5","DOIUrl":"10.1016/0092-1157(88)90014-5","url":null,"abstract":"<div><p>One to four different lots of four commercially available trivalent measles-mumps-rubella vaccines were tested for their efficacy as measured by the induction of antibodies to the three vaccine viruses. All of the products were satisfactory although a 100% seroconversion rate was attained regularly only with rubella vaccine. The live virus in the different measles and mumps vaccine components and especially the relative amounts of measles to mumps virus varied widely. Obviously, the efficacy of a vaccine should not be judged only by the virus content. Of main importance is the further adjustment of the dosage of the interfering vaccine virus strains in relation to their attenuation.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"16 4","pages":"Pages 269-273"},"PeriodicalIF":0.0,"publicationDate":"1988-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(88)90014-5","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14328488","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}