Journal of biological standardization最新文献

{"title":"Study of combined vaccination against yellow fever and measles in infants from six to nine months","authors":"M. Lhuillier ,&nbsp;M.J. Mazzariol ,&nbsp;S. Zadi ,&nbsp;N. Le Cam ,&nbsp;M.C. Bentejac ,&nbsp;L. Adamowicz ,&nbsp;F.N. Marie,&nbsp;B. Fritzell","doi":"10.1016/0092-1157(89)90023-1","DOIUrl":"10.1016/0092-1157(89)90023-1","url":null,"abstract":"<div><p>A study has been carried out in the Ivory Coast to assess the efficacy of a combined vaccine against yellow fever and measles relative to that of each vaccine administered separately. Healthy children aged six to nine months were recruited and divided into two age groups: less than seven months (group I) and more than eight months (group II). In each group, they were randomly assigned to receive either yellow fever vaccine only (A), measles vaccine only (B), or the combined vaccine (C). The serological responses to measles and yellow fever were assessed in 219 initially seronegative children 45 days after immunization. More than 90% of the children developed yellow fever haemagglutination inhibiting antibodies. Neither age nor combination with measles vaccine influenced the responses to yellow fever vaccine. Measles haemagglutinational inhibiting antibodies were found in 97% of the children and the seroconversion rate was influenced neither by age nor by combination with yellow fever vaccine. Younger infants had lower titres of measles antibody.</p><p>No particular adverse reactions were notified during the follow up.</p><p>This study shows that combined yellow fever and measles vaccines are immunogenic in infants from the age of six months. Controlling yellow fever in endemic areas and the prevention of measles in young infants may greatly benefit by this combination.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"17 1","pages":"Pages 9-15"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(89)90023-1","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13681606","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 use of the Toxin Binding Inhibition (ToBI) test for the estimation of the potency of the diphtheria component of vaccines","authors":"C.F.M. Hendriksen ,&nbsp;J.W.v.d. Gun ,&nbsp;J.G. Kreeftenberg","doi":"10.1016/0092-1157(89)90016-4","DOIUrl":"10.1016/0092-1157(89)90016-4","url":null,"abstract":"<div><p>The Toxin Binding Inhibition (ToBI) test, previously developed for the estimation of diphtheria and tetanus antitoxin in human sera, was adapted for the estimation of the potency of diphtheria components in vaccines. Data are presented to show that antitoxin titres of individual sera of mice obtained by the ToBI test are in good agreement with those obtained in the Vero cell test.</p><p>In addition, diphtheria potency and 95% confidence interval of twelve batches of vaccine in different compositions were estimated by the ToBI test and the results were compared with those obtained in Vero cells. A significant correlation could be demonstrated. It is concluded from this study that the ToBI test is a valuable model in the potency assay of diphtheria toxoids, based on antitoxin induction in mice.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"17 3","pages":"Pages 241-247"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(89)90016-4","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13933359","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":"A sensitive method for the detection of residual cell DNA in a recombinant hepatitis B vaccine prepared from Chinese hamster ovary cells","authors":"Tetsuo Yoneyama ,&nbsp;Qi Zibai ,&nbsp;Tatsuo Miyamura","doi":"10.1016/S0092-1157(89)80008-3","DOIUrl":"10.1016/S0092-1157(89)80008-3","url":null,"abstract":"","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"17 4","pages":"Pages 371-375, IN5-IN6"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S0092-1157(89)80008-3","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13677036","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 International Standard for Endotoxin: evaluation in an international collaborative study","authors":"S. Poole ,&nbsp;M.V. Mussett","doi":"10.1016/0092-1157(89)90006-1","DOIUrl":"10.1016/0092-1157(89)90006-1","url":null,"abstract":"<div><p>An ampouled preparation of bacterial endotoxin, coded 84/650, was evaluated in 35 laboratories in 12 countries for its suitability to serve as the International Standard for Endotoxin. The ampouled preparation was calibrated in terms of the USA National Standard, EC5, in Limulus Amoebocyte Lysate gelation, turbidimetric and chromogenic tests and in rabbit pyrogen tests. On the basis of the results reported here, with the agreement of the participants in the study, and with the authorization of the Expert Committee on Biological Standardization of the World Health Organization, the preparation coded 84/650 was established in 1986 as the International Standard for Endotoxin for Limulus Gelation Tests with an assigned unitage of 14 000 IU of endotoxin per ampoule.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"17 2","pages":"Pages 161-171"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(89)90006-1","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13855209","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":"Preclinical investigations of the safety, immunogenicity and efficacy of a purified, inactivated tick-borne encephalitis vaccine","authors":"U. Klockmann ,&nbsp;H.L. Bock ,&nbsp;V. Franke ,&nbsp;B. Hein ,&nbsp;G. Reiner ,&nbsp;J. Hilfenhaus","doi":"10.1016/S0092-1157(89)80004-6","DOIUrl":"10.1016/S0092-1157(89)80004-6","url":null,"abstract":"<div><p>A new tick-borne encephalitis (TBE) vaccine for human use has been developed. TBE virus (TBEV) was propagated in primary chick embryo cells, inactivated by formalin and purified by continuous-flow density gradient centrifugation. The TBE vaccine was tested for innocuity, immunogenicity and protective capacity in a series of laboratory tests. The results indicated that the vaccine is outstandingly well tolerated, highly immunogenic in various laboratory animals, and induces protective immunity in mice. These data suggest that this new vaccine should be studied in clinical trials.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"17 4","pages":"Pages 331-342"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S0092-1157(89)80004-6","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13754727","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":"Standardization of an enzyme immunoassay for the in vitro potency assay of inactivated tissue culture rabies vaccines: determination of the rabies virus glycoprotein with polyclonal antisera","authors":"Olaf Thraenhart ,&nbsp;Kandiah Ramakrishnan","doi":"10.1016/S0092-1157(89)80001-0","DOIUrl":"10.1016/S0092-1157(89)80001-0","url":null,"abstract":"<div><p>A non-competitive enzyme-linked immunoassay (ELISA) has been standardized to supplement the <em>in vivo</em> potency test used for the quality control of inactivated tissue culture vaccines against rabies. The essentials of the ELISA were: fixation of the virus in different dilutions of vaccine on the surface of microtitre plates; testing of the reference and up to six test vaccines on one plate; incubation with polyclonal antisera to rabies virus glycoprotein containing an excess of antibody; further incubation with a species-specific anti-IgG coupled to peroxidase; a final incubation with a substrate. The incubation periods were 1 h, 1 h and 30 min both at +37°C. The relative potency determinations were made graphically or by a computer using a parallel line bioassay in which the potencies of the vaccines of unknown potency were tested against the reference preparation on a single microtitre plate. Under these conditions inactivated rabies vaccines of different types (virus strains, cell substrates, inactivation and concentration procedures) were tested for potency. Furthermore, it was possible with this <em>in vitro</em> method to assay adjuvanted vaccines, in process samples such as tissue culture supernatants with live or inactivated rabies virus, concentrates, and vaccines undergoing thermal stability tests.</p><p>The rabies glycoprotein antigen-antibody reaction was highly specific according to the results and the glycoprotein content was measured quantitatively. The potency determined by the <em>in vitro</em> ELISA correlated with the <em>in vivo</em> NIH protection potency test. The lower limit of detection of the ELISA was 0·015 IU/ml.</p><p>Quantitative antigen determination was possible with both homologous and heterologous antisera to rabies virus glycoprotein when vaccines of the same virus strain were tested. When the potencies of vaccines of different virus strain specificity were calculated, it was necessary to take into account the strain-specific antigenicity. Even so vaccines of high potency were found to give a stronger reaction with a heterologous serum than did weak vaccines with a homologous antiserum.</p><p>Stability tests made on inactivated tissue culture vaccines such as vaccine from the human diploid cell strain (HDCS), from purified chicken embryo cell (PCEC) or from purified Vero cell rabies vaccine (PVRV), showed high stability of the glycoprotein antigen even after four months of storage at +37°C or 24 h at +56°C, provided that the vaccines were stored in a lyophilized state. The antigenicity of liquid vaccines was inactivated after a few hours at + 56°C. For tropical areas, therefore, only lyophilized vaccines should be considered.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"17 4","pages":"Pages 291-309"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S0092-1157(89)80001-0","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13755494","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":"Mumps vaccine L-Zagreb, prepared in chick fibroblasts. I. Production and field trials","authors":"M. Beck ,&nbsp;R. Welsz-Malecek ,&nbsp;M. Mesko-Prejac ,&nbsp;V. Radman ,&nbsp;M. Juzbasic,&nbsp;M. Rajninger-Miholic ,&nbsp;M. Prislin-Musklic ,&nbsp;V. Dobrovsak-Sourek ,&nbsp;S. Smerdel ,&nbsp;D.W. Stainer","doi":"10.1016/0092-1157(89)90031-0","DOIUrl":"10.1016/0092-1157(89)90031-0","url":null,"abstract":"<div><p>Leningrad-L3 Mumps Vaccine virus has been further attenuated by adaptation and passage on SPF chick embryo fibroblast cell cultures. This new mumps strain has been designated L-Zagreb and has been used to prepare mumps vaccines which meet the WHO requirements. Observations during both the field trial period prior to registration and during the later use of the vaccine showed that the few reactions observed were mild and that seroconversion was obtained in 88–98% of vaccinees. The morbidity of mumps in Croatia declined more than tenfold after the introduction of the new vaccine. During a mumps epidemic, vaccine efficiency was calculated to be 97–100%.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"17 1","pages":"Pages 85-90"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(89)90031-0","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13788557","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":"An international collaborative study of an anti-infectious bursal disease virus reference serum","authors":"N.E. Reed ,&nbsp;Denise H. Thornton ,&nbsp;C. Nancy Hebert ,&nbsp;J.C. Muskett ,&nbsp;G.W. Wood","doi":"10.1016/S0092-1157(89)80007-1","DOIUrl":"10.1016/S0092-1157(89)80007-1","url":null,"abstract":"<div><p>Fourteen laboratories participated in a collaborative study of a freeze-dried preparation of anti-infectious bursal disease virus serum to assess the suitability of the serum as a standard for use in the infectious bursal disease virus neutralization test. Ten laboratories carried out micro-virus neutralization tests and six carried out plaque reduction tests, two laboratories carrying out both tests. When titres were expressed as a proportion of that obtained for a reference preparation there was a marked reduction in variation between results from different laboratories. The use of a reference preparation was therefore of value when comparing results from different laboratories. It is proposed that the reference preparation used in this study be used as a standard to facilitate the comparison of results from different laboratories. The poroposed standard contains by definition 10 000 UK units.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"17 4","pages":"Pages 361-369"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S0092-1157(89)80007-1","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13703361","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 detection of Clostridium perfringens epsilon antitoxin in rabbit serum by monoclonal antibody based competition ELISA","authors":"Marcjanna G. Sojka ,&nbsp;Victor J. White ,&nbsp;Christopher J. Thorns ,&nbsp;Peter L. Roeder","doi":"10.1016/0092-1157(89)90002-4","DOIUrl":"10.1016/0092-1157(89)90002-4","url":null,"abstract":"<div><p>A competitive enzyme-linked immunosorbent assay (CELISA) has been developed, standardized and compared with the toxin neutralization (TN) test performed in mice for the measurement of antibody responses in rabbits vaccinated with clostridial vaccines. In CELISA, sera were tested at a single dilution for their ability to compete with the reaction between a monoclonal antibody, which neutralizes epsilon toxin, and epsilon toxoid coated on to a solid phase. The results of the two tests correlated well. CELISA was specific, rapid, reproducible and simple to perform and offered an alternative to the TN test that reduced the requirement for experimental animals in the potency testing of clostridial vaccines.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"17 2","pages":"Pages 117-124"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(89)90002-4","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13855208","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":"Assessment of the biological stability of human thyroid stimulating hormone prepared by immunoaffinity chromatography","authors":"Richard W. Blazek ,&nbsp;Susan C. Randles","doi":"10.1016/0092-1157(89)90007-3","DOIUrl":"10.1016/0092-1157(89)90007-3","url":null,"abstract":"<div><p>This paper reports a comprehensive study of the biological stability of an immunoaffinity purified preparation of human thyroid stimulating hormone (TSH) and provides a reference against which future natural or synthetic preparations may be compared. The stability of the hormone preparation was investigated using the accelerated degradation method. The bioassay of the TSH was carried out in mice using a modified McKenzie method. Analysis of the results showed that the preparation was as stable as other TSH preparations purified by conventional methods.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"17 2","pages":"Pages 173-179"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(89)90007-3","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13855210","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}