NIPH annals最新文献

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The Norwegian meningococcal serogroup B outer membrane vesicle vaccine protection trials: case tracing, meningococcal antigen detection and serological diagnosis. 挪威脑膜炎球菌血清B组外膜囊泡疫苗保护试验:病例追踪、脑膜炎球菌抗原检测和血清学诊断。
NIPH annals Pub Date : 1991-12-01
E A Høiby, G Bjune, L O Frøholm, J Eng, A Halstensen, E Rosenqvist, E Rønnild, E Wedege
{"title":"The Norwegian meningococcal serogroup B outer membrane vesicle vaccine protection trials: case tracing, meningococcal antigen detection and serological diagnosis.","authors":"E A Høiby,&nbsp;G Bjune,&nbsp;L O Frøholm,&nbsp;J Eng,&nbsp;A Halstensen,&nbsp;E Rosenqvist,&nbsp;E Rønnild,&nbsp;E Wedege","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>A survey is given of the efforts made to inform the general public, the potential vaccinees and their parents, and the health care personnel about meningococcal disease in general and the vaccination trial in particular, as a preparation for the meningococcal outer membrane vesicle serogroup B vaccine (MenB-vaccine \"Folkehelsa\") trials in secondary school students and military conscripts in Norway. Our case reporting system, supplementing the official notification, concerning even vaguely suspected cases in the age cohorts involved, is described. The efforts made to collect clinical material as well as laboratory and clinical data from 221 registered suspected cases are delineated. We also briefly summarize our cerebrospinal fluid antigen detection methods and diagnostic meningococcal serology work on these suspected cases. The compiled information on findings done at the admitting hospital of the possible cases and the additional diagnostic data provided at the National Institute of Public Health were put at the disposal of the independent Diagnosis Review Committee (DRC) as a basis for their diagnostic decisions before code opening for the meningococcal serogroup B outer membrane vesicle vaccine protection trial 3 June 1991.</p>","PeriodicalId":76239,"journal":{"name":"NIPH annals","volume":"14 2","pages":"107-21; discussion 121-3"},"PeriodicalIF":0.0,"publicationDate":"1991-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"12974182","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}
引用次数: 0
Human antibody responses after vaccination with the Norwegian group B meningococcal outer membrane vesicle vaccine: results from ELISA studies. 接种挪威B组脑膜炎球菌外膜囊泡疫苗后的人抗体反应:ELISA研究结果
NIPH annals Pub Date : 1991-12-01
E Rosenqvist, E A Høiby, G Bjune, K Bryn, O Closs, B Feiring, A Klem, H Nøkleby, L O Frølm
{"title":"Human antibody responses after vaccination with the Norwegian group B meningococcal outer membrane vesicle vaccine: results from ELISA studies.","authors":"E Rosenqvist,&nbsp;E A Høiby,&nbsp;G Bjune,&nbsp;K Bryn,&nbsp;O Closs,&nbsp;B Feiring,&nbsp;A Klem,&nbsp;H Nøkleby,&nbsp;L O Frølm","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Antibody responses after vaccination with three different formulations of a new meningococcal group B outer membrane vesicle (OMV) vaccine have been studied with the ELISA technique using four different antigens. Sera from about 1200 vaccinees participating in steps 1, 2, 3 and 6 of the phase II clinical trials in Norway were analysed. The effects of non-covalently complexing the OMV antigen to group C polysaccharide (C-PS) and of adsorbing OMV (with and without C-PS) to aluminium hydroxide (AH) were studied. All three vaccine formulations were highly immunogenic in humans. Adsorption of the vaccine to AH had a relatively small effect on the immune response, but the results indicated that the booster response was stronger with the adsorbed than with the unadsorbed vaccines. Some increase in the immune response against OMV was also observed by non-covalent complexing OMV with C-PS, particularly after the second dose. In most of the vaccinees the antibody levels were significantly reduced 6 to 12 months after vaccination. Adsorption of the vaccine to AH had no effect on the antibody response against C-PS. Comparison with bactericidal activity of the same sera was done. A highly significant correlation was observed between the bactericidal titres and the levels of IgG antibodies against OMV and class 5C protein, whereas the correlation between antibody levels against lipopolysaccharide and the bactericidal activity was poor.</p>","PeriodicalId":76239,"journal":{"name":"NIPH annals","volume":"14 2","pages":"169-79; discussion 180-1"},"PeriodicalIF":0.0,"publicationDate":"1991-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"12852649","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}
引用次数: 0
The Norwegian meningococcal group B outer membrane vesicle vaccine: side effects in phase II trials. 挪威脑膜炎球菌B组外膜囊泡疫苗:II期试验的副作用
NIPH annals Pub Date : 1991-12-01
H Nøkleby, B Feiring
{"title":"The Norwegian meningococcal group B outer membrane vesicle vaccine: side effects in phase II trials.","authors":"H Nøkleby,&nbsp;B Feiring","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In order to establish the safety of the Norwegian meningococcus B vaccine we have focused on detailed reporting of side effects in several phase II trials. We report here the results of the largest single phase II study, (step II-6) including 877 school children. The incidence of local side effects was significantly higher in the vaccine than in the placebo group, but most of them were mild and short-lasting. Mild systemic side effects were commonly reported in both groups, but more severe side effects were rare and almost equally distributed between the groups.</p>","PeriodicalId":76239,"journal":{"name":"NIPH annals","volume":"14 2","pages":"95-101; discussion 101-2"},"PeriodicalIF":0.0,"publicationDate":"1991-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"12974126","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}
引用次数: 0
Meningococcal disease in São Paulo, Brazil. 巴西圣保罗的脑膜炎球菌病。
NIPH annals Pub Date : 1991-12-01
W Costa, C T Sacchi, S Ramos, L Milagres, L S Prigenzi
{"title":"Meningococcal disease in São Paulo, Brazil.","authors":"W Costa,&nbsp;C T Sacchi,&nbsp;S Ramos,&nbsp;L Milagres,&nbsp;L S Prigenzi","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":76239,"journal":{"name":"NIPH annals","volume":"14 2","pages":"215-6; discussion 216-8, 222-4"},"PeriodicalIF":0.0,"publicationDate":"1991-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"12974192","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}
引用次数: 0
Production, characterization and control of MenB-vaccine "Folkehelsa": an outer membrane vesicle vaccine against group B meningococcal disease. “Folkehelsa”脑膜炎疫苗的生产、鉴定和控制:一种针对B群脑膜炎球菌病的外膜囊泡疫苗。
NIPH annals Pub Date : 1991-12-01
J H Fredriksen, E Rosenqvist, E Wedege, K Bryn, G Bjune, L O Frøholm, A K Lindbak, B Møgster, E Namork, U Rye
{"title":"Production, characterization and control of MenB-vaccine \"Folkehelsa\": an outer membrane vesicle vaccine against group B meningococcal disease.","authors":"J H Fredriksen,&nbsp;E Rosenqvist,&nbsp;E Wedege,&nbsp;K Bryn,&nbsp;G Bjune,&nbsp;L O Frøholm,&nbsp;A K Lindbak,&nbsp;B Møgster,&nbsp;E Namork,&nbsp;U Rye","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>A vaccine against serogroup B meningococcal disease has been prepared from a B:15:P1.7,16 meningococcal strain (44/76) by fermentor growth and extraction of the bacteria with the detergent deoxycholate. Outer membrane vesicles (OMV) were purified by ultracentrifugation and adsorbed to aluminium hydroxide adjuvant. OMV contained the major class 1, 3, 4 and 5 proteins and some minor high molecular weight protein components. Relative to protein, the vaccine also contained about 8% phospholipid, 7% lipopolysaccharide and 16% deoxycholate. The product was generally non-pyrogenic to humans in ordinary doses and was highly immunogenic in mice and humans. Production and control steps, physical, chemical and immunological data for the vaccine are described.</p>","PeriodicalId":76239,"journal":{"name":"NIPH annals","volume":"14 2","pages":"67-79; discussion 79-80"},"PeriodicalIF":0.0,"publicationDate":"1991-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"12974124","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}
引用次数: 0
Adverse events following vaccine or placebo injection in an efficacy trial of an outer membrane vesicle vaccine against group B meningococcal disease in Norwegian secondary schools 1988-1991. 1988-1991年挪威中学B群脑膜炎球菌病外膜囊泡疫苗疗效试验中疫苗或安慰剂注射后的不良事件
NIPH annals Pub Date : 1991-12-01
P Aavitsland, G Bjune, S Aasen, S Halvorsen
{"title":"Adverse events following vaccine or placebo injection in an efficacy trial of an outer membrane vesicle vaccine against group B meningococcal disease in Norwegian secondary schools 1988-1991.","authors":"P Aavitsland,&nbsp;G Bjune,&nbsp;S Aasen,&nbsp;S Halvorsen","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":76239,"journal":{"name":"NIPH annals","volume":"14 2","pages":"133-4; discussion 136-7"},"PeriodicalIF":0.0,"publicationDate":"1991-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"12974184","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}
引用次数: 0
The meningococcal serogroup B vaccine protection trial in Norway 1988-1991: trial surveillance by an independent group. 1988-1991年挪威脑膜炎球菌血清B组疫苗保护试验:由一个独立小组进行的试验监测
NIPH annals Pub Date : 1991-12-01
S Halvorsen
{"title":"The meningococcal serogroup B vaccine protection trial in Norway 1988-1991: trial surveillance by an independent group.","authors":"S Halvorsen","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":76239,"journal":{"name":"NIPH annals","volume":"14 2","pages":"135-6; discussion 136-7"},"PeriodicalIF":0.0,"publicationDate":"1991-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"12974185","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}
引用次数: 0
Immunoblotting studies of vaccinee and patient sera from a Norwegian serogroup B meningococcal vaccination trial. 来自挪威血清B群脑膜炎球菌疫苗接种试验的疫苗接种者和患者血清的免疫印迹研究。
NIPH annals Pub Date : 1991-12-01
E Wedege, G Bjune, L O Frøholm, E A Høiby, E Rosenqvist
{"title":"Immunoblotting studies of vaccinee and patient sera from a Norwegian serogroup B meningococcal vaccination trial.","authors":"E Wedege,&nbsp;G Bjune,&nbsp;L O Frøholm,&nbsp;E A Høiby,&nbsp;E Rosenqvist","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":76239,"journal":{"name":"NIPH annals","volume":"14 2","pages":"183-4; discussion 185-6"},"PeriodicalIF":0.0,"publicationDate":"1991-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"12974189","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}
引用次数: 0
Serum opsonins to serogroup B meningococci after disease and vaccination. 脑膜炎球菌患病及接种后血清调理素的变化。
NIPH annals Pub Date : 1991-12-01
A Halstensen, A K Lehmann, H K Guttormsen, S E Vollset, G Bjune, A Naess
{"title":"Serum opsonins to serogroup B meningococci after disease and vaccination.","authors":"A Halstensen,&nbsp;A K Lehmann,&nbsp;H K Guttormsen,&nbsp;S E Vollset,&nbsp;G Bjune,&nbsp;A Naess","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In this review the results of three previous studies are compared and discussed. Sera from 101 patients with meningococcal disease and from 113 volunteers immunized twice with vaccine preparations against serogroup B meningococci were examined for antimeningococcal opsonic activity using a chemiluminescence (CL) method. Twelve groups of vaccinees were immunized twice with one of four different doses of an outer membrane vesicle (OMV) preparation either alone or complexed to serogroup C polysaccharide and/or the adjuvant Al(OH)3. The OMV vaccine strain (44/76) was a patient isolate characterized as B:15:P1.16. The 89 surviving patients and 97/113 volunteers responded with significantly increased opsonic activity to the vaccine strain. Sera from all vaccinees with low preimmunization levels demonstrated a significant postimmunization increase in opsonic activity. The vaccine response was dose related, and the second injection induced a booster response in those who received preparations containing Al(OH)3. At 26 weeks a reduction in opsonic activity to preimmunization levels was noted in 19/97 previous responders. The reduction was less pronounced in those who were immunized with the higher doses. Using CL and flow cytometry we found vaccinee sera to show cross reacting opsonin responses to other serogroups and serotypes of meningococci except meningococci of serotype 2a and 2b. The increase in antimeningococcal opsonins after vaccination suggests that the serogroup B OMV vaccine may induce protection against clinical disease.</p>","PeriodicalId":76239,"journal":{"name":"NIPH annals","volume":"14 2","pages":"157-65; discussion 166-7"},"PeriodicalIF":0.0,"publicationDate":"1991-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"12974188","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}
引用次数: 0
Design of clinical trials with an outer membrane vesicle vaccine against systemic serogroup B meningococcal disease in Norway. 挪威外膜囊泡疫苗预防系统性血清B群脑膜炎球菌病的临床试验设计
NIPH annals Pub Date : 1991-12-01
G Bjune, O Closs, L O Frøholm, J K Grønnesby, E A Høiby, H Nøkleby
{"title":"Design of clinical trials with an outer membrane vesicle vaccine against systemic serogroup B meningococcal disease in Norway.","authors":"G Bjune,&nbsp;O Closs,&nbsp;L O Frøholm,&nbsp;J K Grønnesby,&nbsp;E A Høiby,&nbsp;H Nøkleby","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>An outer membrane vesicle vaccine against acute, systemic disease caused by meningococci of serogroup B has been developed. The vaccine has been tested consecutively in phase I and phase II clinical trials including more than 5000 volunteers. These trials provided data on safety, immunogenicity and reactogenicity and possible effect on carriage of meningococci in the throat, and consequently formed the basis for two major protection trials; one in secondary school students and one among military recruits. The aims, design and major results of phase I and phase II studies are described as well as the design and organization of the protection trials.</p>","PeriodicalId":76239,"journal":{"name":"NIPH annals","volume":"14 2","pages":"81-91; discussion 91-3"},"PeriodicalIF":0.0,"publicationDate":"1991-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"12974125","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}
引用次数: 0
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