{"title":"An evaluation of some proposals for a reduction in the number of animals used for the potency testing of diphtheria and tetanus vaccines","authors":"P.A. Knight , P.A.G. Roberts","doi":"10.1016/0092-1157(87)90039-4","DOIUrl":"10.1016/0092-1157(87)90039-4","url":null,"abstract":"<div><p>Analysis of data from small subgroups of animals used in potency tests for vaccines containing diphtheria and tetanus components has shown that, in most cases, satisfactory assurance of potency can be obtained with much smaller numbers of animals than are currently prescribed by the pharmacopoeias. It is suggested that when the criterion of potency for a vaccine is defined in terms of the lower fiducial limit of potency, the additional prescription of a minimum number of animals for the test is unnecessary. Furthermore, when well standardized, lyophilized toxins are used for challenge, there is no need to determine the LD<sub>50</sub> of the challenge toxin on every occasion. The possibility of obtaining assurance of potency with smaller numbers of animals using single point comparisons of unknown and standard vaccines is also discussed.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"15 2","pages":"Pages 165-175"},"PeriodicalIF":0.0,"publicationDate":"1987-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(87)90039-4","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14719180","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}
U. Hennes , W. Jucker , E.A. Fischer , Th. Krummenacher , A.V. Palleroni , P.W. Trown , S. Linder-Ciccolunghi , M. Rainisio
{"title":"The detection of antibodies to recombinant interferon alfa-2a in human serum","authors":"U. Hennes , W. Jucker , E.A. Fischer , Th. Krummenacher , A.V. Palleroni , P.W. Trown , S. Linder-Ciccolunghi , M. Rainisio","doi":"10.1016/0092-1157(87)90026-6","DOIUrl":"10.1016/0092-1157(87)90026-6","url":null,"abstract":"<div><p>Three different procedures have been used for detecting antibodies to Roferon-A (recombinant human interferon alfa-2a, rHuIFNα-2a) in the serum of patients who received this interferon as part of ongoing clinical trials: an antiviral neutralization bioassay (ANB), the standard method recommended by the World Health Organization (WHO), and the more recently developed radioimmunoassay (RIA) and enzymeimmunoassay (EIA). Although the three tests are based on different principles, the correlation among them was excellent. The assays show differences in sensitivities with the ANB being the least sensitive of the three. The EIA equals the RIA in sensitivity, reproducibility, accuracy and labor and provides the advantage of safety and convenience in the use of non-radioactive materials. Therefore, the EIA has been selected as the most suitable assay for initial screening of the sera of patients receiving Roferon-A for the presence of antibodies to this interferon. EIA positive sera are then tested in the ANB to determine whether or not neutralizing activities are present.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"15 3","pages":"Pages 231-244"},"PeriodicalIF":0.0,"publicationDate":"1987-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(87)90026-6","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14430213","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 quantitation of human growth hormone by a radioreceptor assay using an established human cell line","authors":"Thore Nederman , Lars Sjödin","doi":"10.1016/0092-1157(87)90023-0","DOIUrl":"10.1016/0092-1157(87)90023-0","url":null,"abstract":"<div><p>Membrane receptors on cultured human lymphocytes (IM-9) have been shown to bind human growth hormone (hGH) in a specific manner. The aim of the present study was to develop an <em>in vitro</em> assay of hGH based on this binding. The assay should fulfil established pharmacopoeial requirements for quantitation of hormones. The binding of [<sup>125</sup>I]hGH was studied as a function of time, temperature, cell density, tracer concentration and the concentration of unlabelled hGH and other related hormones. Also, the dissociation of bound hGH and the chemical stability of hGH in the incubation medium were studied. From these studies, the conditions for an appropriate radioreceptor assay were determined. Briefly, 1·5–3·0 × 10<sup>7</sup> cells ml<sup>−1</sup> were incubated with 5–20 × 10<sup>−12</sup> <span>m</span> [<sup>125</sup>I]hGH and three different concentrations of unlabelled hGH chosen from the linear part of the [<sup>125</sup>I]hGH displacement curve. The results were analyzed according to general pharmacopoeial principles. The mean values for growth hormone activity tested by radioreceptor assay were within the fiducial limits (<em>P</em> = 0·05) of the corresponding activity determined by the hypophysectomized rat body-weight gain assay. The <em>in vitro</em> assay was found to be more precise and less resource demanding than the <em>in vivo</em> bioassay of hGH. It is concluded that the <em>in vitro</em> bioassay described here is well suited as a screening method for potency determination of hGH preparations.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"15 3","pages":"Pages 199-211"},"PeriodicalIF":0.0,"publicationDate":"1987-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(87)90023-0","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14732073","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 detoxification of Bordetella pertussis with glutaraldehyde","authors":"T. Iida , Y. Horiuchi","doi":"10.1016/0092-1157(87)90013-8","DOIUrl":"10.1016/0092-1157(87)90013-8","url":null,"abstract":"<div><p>To improve the whole-cell pertussis vaccine we have studied the inactivacion of the biological properties characteristic of <em>Bordetella pertussis</em> phase I bacteria, i.e. histamine-sensitizing, lymphocytosis-promoting and mouse protective activities, by treating a concentrated bacterial suspension with various concentrations of glutaraldehyde. Under the experimental conditions, treatment with 10 m<span>m</span> glutaraldehyde at 37 °C for 30 min resulted in a marked reduction of the toxic activities without grossly diminishing the protective potency. Further tests were performed on the stability of the protective potency, on the agglutinin production in mice, and on the freedom from abnormal toxicity in guinea-pigs.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"15 1","pages":"Pages 17-26"},"PeriodicalIF":0.0,"publicationDate":"1987-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(87)90013-8","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14019429","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 modification of the natural killer cell assay by substitution of 111indium for 51Chromium","authors":"Andrew D. Blann","doi":"10.1016/S0092-1157(87)80011-2","DOIUrl":"10.1016/S0092-1157(87)80011-2","url":null,"abstract":"<div><p>Natural killer (NK) cells are a heterogenous subgroup of lymphocytes possessing the ability to lyse spontaneously various normal, virally infected and transformed cell lines without prior sensitization. Although their lytic activity can be augmented by interferon and interleukin-2, and their function can be inhibited by prostaglandins and corticosteroids, their precise physiological or immunological role has not yet been determined. Roles in anti-tumour surveillance, resistance to viral infection and haemopoietic regulation have been suggested. NK activity has been shown to be defective in a number of diverse conditions such as the Chediak-Higashi syndrome, systemic lupus erythematosus, sarcoidosis and pregnancy. Most current estimations of NK activity rely on a modification of Brunner's cell mediated cytotoxicity assay in which cells bearing NK activity are co-cultured with chromium-labelled K562, a cell line derived from a myeloid leukaemia. However, the work of this and other groups have demonstrated the advantages of indium in isotope-release assays. Hence the experiments described in this report were undertaken to evaluate the use of indium in the NK/K562 assay.</p><p>Cell line K562 was maintained in permanent cell culture at 37°C in a humidified atmosphere of 5% CO2, 95% air in RPMI 1640 cell-culture medium supplemented with 10% foetal calf serum (FCS), 100 IU ml<sup>-1</sup> of penicillin, 100 μg ml<sup>-1</sup> of streptomycin and 2 mM of L-glutamine. All cell culture plastics and medium were obtained from Flow or Gibco.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"15 4","pages":"Pages 379-383"},"PeriodicalIF":0.0,"publicationDate":"1987-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S0092-1157(87)80011-2","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14800230","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}
Anja R. ter Avest , Gijsbert van Steenis , Albert D.M.E. Osterhaus
{"title":"A comparison of an enzyme-linked immunosorbent assay and counter current electrophoresis for the detection of bovine serum albumin in virus vaccines","authors":"Anja R. ter Avest , Gijsbert van Steenis , Albert D.M.E. Osterhaus","doi":"10.1016/0092-1157(87)90027-8","DOIUrl":"10.1016/0092-1157(87)90027-8","url":null,"abstract":"<div><p>A monoclonal antibody directed against bovine serum albumin (BSA) has been developed and used in an enzyme-linked immunosorbent assay (ELISA) system for the detection of BSA in virus vaccines. The results correlated well with those obtained with a counter current electrophoresis system which has been employed routinely for this purpose. The ELISA was slightly more sensitive and more readily applicable to the screening of large numbers of samples but could not be used in the presence of certain stabilizers.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"15 3","pages":"Pages 245-250"},"PeriodicalIF":0.0,"publicationDate":"1987-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(87)90027-8","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14731978","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 reverse indirect haemagglutination test for the in-process quality control of Japanese encephalitis vaccine","authors":"R.K. Gupta , V.K. Mehta , V.K. Gupta , C.N. Misra , S.N. Saxena","doi":"10.1016/0092-1157(87)90032-1","DOIUrl":"10.1016/0092-1157(87)90032-1","url":null,"abstract":"","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"15 3","pages":"Pages 287-291"},"PeriodicalIF":0.0,"publicationDate":"1987-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(87)90032-1","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14731982","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}
R. Glück , A. Wegmann , H. Keller , J.M. Hoskins , R. Germanier
{"title":"Human rabies immunoglobulin assayed by the rapid fluorescent focus inhibition test suppresses active rabies immunization","authors":"R. Glück , A. Wegmann , H. Keller , J.M. Hoskins , R. Germanier","doi":"10.1016/0092-1157(87)90040-0","DOIUrl":"10.1016/0092-1157(87)90040-0","url":null,"abstract":"<div><p>The rabies antibody content of each of ten lots of human rabies immunoglobulin was titrated by both the mouse neutralization test and the rapid fluorescent focus inhibition test. The two tests did not give comparable results, the antibody titres obtained by the mouse neutralization test being 1·4–9·6 times higher than those obtained by the rapid fluorescent focus inhibition test. This titre difference was associated with a consistently lower antibody response in human volunteers who had received post-exposure rabies vaccine treatment which included the administration of RIG assayed by the RFFIT.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"15 2","pages":"Pages 177-183"},"PeriodicalIF":0.0,"publicationDate":"1987-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(87)90040-0","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14426979","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 immunization of children with combined diphtheria and tetanus vaccine in Sweden","authors":"Kerstin Larsen , Karin Ullberg-Olsson , Birgitta Wickbom , Bengt Hederstedt","doi":"10.1016/0092-1157(87)90033-3","DOIUrl":"10.1016/0092-1157(87)90033-3","url":null,"abstract":"<div><p>Two groups derived from 97 children three-four months of age were vaccinated with diphtheria and tetanus vaccines containing either a routinely prepared diphtheria toxoid or a more purified preparation. Two injections were given with an interval of one month and a third injection was given one year after the first.</p><p>Prior to the third injection no child was without protection against diphtheria, i.e. had an antitoxin titre <0·01 IU ml<sup>−1</sup>. After the third injection 95 and 94% of the children vaccinated with the routinely and more purified diphtheria toxoids, respectively, had diphtheria antitoxin titres >1 IU ml<sup>−1</sup> (estimated to provide protection for at least ten years).</p><p>Systemic reactions such as fever and malaise occurred in five children. Local reactions >10 cm were observed in three children and reactions >5 but ⩽10 cm were seen in 14% of the children.</p><p>The routinely prepared combined diphtheria and tetanus vaccine, DT, produced very good immunity against diphtheria with moderate side effects. The use of a more purified diphtheria toxoid in the combined vaccine produced the same immunity and side effects.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"15 2","pages":"Pages 103-107"},"PeriodicalIF":0.0,"publicationDate":"1987-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(87)90033-3","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14719176","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}
Kerstin Larsen , Karin Ullberg-Olsson , Erik Ekwall , Bengt Hederstedt
{"title":"The immunization of adults against diphtheria in Sweden","authors":"Kerstin Larsen , Karin Ullberg-Olsson , Erik Ekwall , Bengt Hederstedt","doi":"10.1016/0092-1157(87)90034-5","DOIUrl":"10.1016/0092-1157(87)90034-5","url":null,"abstract":"<div><p>Two hundred and three women who disclaimed vaccination against diphtheria were divided into four groups and injected with either 2·0 or 6·25 Lf of a routine diphtheria toxoid or of a more purified preparation. One hundred and twenty-six of these women who did not show a secondary antibody response were given a second and a third injection one month and one year, respectively, after the first injection.</p><p>Prebooster (third injection) antitoxin titres of ⩾0·01 IU ml<sup>−1</sup> (the minimum level tor protection) were found in 22 and 37% of those who received 2·0 and 6·25 Lf, respectively. Postbooster titres of ⩾1·0 IU ml<sup>−1</sup> (calculated to give a protection of at least ten years of duration) were found in 23 and 58% of those who received 2·0 and 6·25 Lf, respectively.</p><p>The rate of untoward reactions was low. Fever of short duration occurred in five women. Four out of the five women received 6·25 Lf of the more purified diphtheria toxoid and one 2 Lf of the routine toxoid. Local reactions >10 cm were observed in three women. All received the higher dose, 6·25 Lf of diphtheria toxoid. Local reactions >5 but ⩽10 cm occurred in up to 13% (6·25 Lf of diphtheria toxoid). No significant difference between the groups of women vaccinated with routine or more purified toxoid was found.</p><p>It was concluded that the diphtheria toxoids in the two doses of 2 Lf and 6·25 Lf did not induce a satisfactory immune response. To induce adequate protection the dose of diphtheria vaccine needs to be the same for adults and children, i.e. 12·5 Lf.</p></div>","PeriodicalId":75991,"journal":{"name":"Journal of biological standardization","volume":"15 2","pages":"Pages 109-116"},"PeriodicalIF":0.0,"publicationDate":"1987-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/0092-1157(87)90034-5","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14719177","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}