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Biomedical subjects

G Bjune

Publications and source records attributed to G Bjune.

At least 19 recordsLinked to original sources
PubMed1991

Effect of outer membrane vesicle vaccine against group B meningococcal disease in Norway.

For more than 15 years, Norway has had the highest incidence of meningococcal disease in northern Europe, with 80% of cases being due to serogroup B meningococci. The case-fatality has remained high, at about 10%. In this study, an outer membrane vaccine, which had previously been shown to induce an increase in bactericidal antibodies to the parent strain, was assessed in a large-scale, randomised, double-blind trial. From October, 1988, 171,800 students in secondary schools volunteered to take part in a double-blind, placebo-controlled, efficacy trial with school as the randomisation unit. Hospitals and clinics that routinely receive patients with infectious disease were asked to report urgently all cases of suspected meningitis and/or septicaemia in 13-21-year-old students in Norway. These cases were registered and further investigated according to a detailed protocol. 89 out of the 221 cases investigated by June 3, 1991, were shown to be severe systemic disease due to group B meningococci. 36 cases in 35 schools took part in the trial (11 schools with vaccinated students and 24 with students given placebo). The calculated rate of protection was thus 57.2% (p = 0.012, one-sided test). The findings suggest that, although the vaccine conferred protection against group B meningococcal disease, the effect was insufficient to justify a public vaccination programme.

Adolescent↗
PubMed1991

[Vaccines and developing countries].

Infectious diseases are the main cause of mortality and morbidity in developing countries. The Expanded Programme on Immunization, initiated by WHO in 1974, now reaches 60 mill. a year at a cost of less than 2 US $ per immunized child, and saves 2.2 mill. lives annually. The present vaccines, however, have significant shortcomings. Measles vaccine is given too late to prevent the large number of deaths occurring in the first year of life. Attenuated polio vaccine has to be given three times and inherits the risk of "vaccine palsy" and revertion to virulence. Tetanus vaccine given to children does not prevent neonatal tetanus, the main cause of tetanus casualties. BCG does not control spread of tuberculosis. Vaccines given parenterally involve some risk of spread of HIV, and some potentially useful vaccines are too expensive for developing countries. By only modest investments modern gene technology could give improved and new vaccines which would potentially save 20 mill. lives a year. Particularly promising is the recent development of multi-vaccine-vectors. However, poor prospects for profit in developing countries and patent "swapping" by commercial producers severely hamper development in the vaccine field.

Developing Countries↗
PubMed1991

Interpreting complicated chromatographic patterns.

GC-MS, HPLC, automatic amino acid analysis, high-resolution two-dimensional electrophoresis and capillary electrophoresis are suitable for the multicomponent analysis of body fluids and tissues. Manual interpretation of the complex metabolite and protein profiles thereby obtained is usually difficult, except in the case of metabolic disorders, where major deviations from the normal profiles often are observed. Implementation of multivariate data analysis makes it possible to retrieve diagnostic information that otherwise may be overlooked, as shown in this report where patients with leprosy have been examined. Urine samples were analysed by ion-exchange chromatography and by GC-MS to obtain profiles of amino acids and organic acids. Qualitative and quantitative information on 68 metabolites were then analysed by principal components analysis (PCA) and by partial least square models (PLS). Three different PLS dimensions were found (cross-validation) corresponding to controls (persons without leprosy), paucibacillary and multibacillary leprosy.

Amino Acids↗
PubMed1991

Human antibody responses after vaccination with the Norwegian group B meningococcal outer membrane vesicle vaccine: results from ELISA studies.

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.

Adolescent↗
PubMed1991

The Norwegian meningococcal serogroup B outer membrane vesicle vaccine protection trials: case tracing, meningococcal antigen detection and serological diagnosis.

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.

Bacterial Capsules↗
PubMed1991

Results of an efficacy trial with an outer membrane vesicle vaccine against systemic serogroup B meningococcal disease in Norway.

A placebo controlled, double blind efficacy trial with a new outer membrane vesicle vaccine against systemic meningococcal disease of serogroup B, has been conducted in Norwegian secondary schools. The study was randomized at school level (1335 schools) and 171,800 students volunteered. The study started in October 1988 and the code was opened in June 1991. Out of the thirty-six proven cases of acute, severe, systemic disease caused by serogroup B meningococci among the participants, twelve occurred in eleven schools given vaccine, twenty-four in twenty-four schools given placebo. twenty-four cases were recorded among secondary school students who did not participate in the study. The protection rate was calculated to 57.4% with a p-value of 1.2% and lower limit of confidence (95%) to 27.7%. The results have initiated research towards an improved outer membrane vesicle vaccine against this disease.

Adolescent↗
PubMed1991

Bactericidal antibodies after vaccination with the Norwegian meningococcal serogroup B outer membrane vesicle vaccine: a brief survey.

Results from the serum bactericidal assay (BA) after immunization of human volunteers with the Norwegian serogroup B meningococcal outer membrane vesicle vaccine are surveyed. In the phase II trials with adults we found very high seroconversion rates (greater than 98%) against the vaccine strain in the BA. Details in the antigenic composition of the inoculum used in the BA seem very important as shown here by finding lower bactericidal titres with teenager sera when tested with a variant of the standard inoculum. The present preliminary report corresponds to the presentation given at the Report Meeting on the Norwegian Meningococcal Vaccine Trial, Oslo, 12 September, 1991.

Adolescent↗
PubMed1991

Serum opsonins to serogroup B meningococci after disease and vaccination.

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.

Adolescent↗
PubMed1991

Production, characterization and control of MenB-vaccine "Folkehelsa": an outer membrane vesicle vaccine against group B meningococcal disease.

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.

Bacterial Capsules↗
PubMed1991

Design of clinical trials with an outer membrane vesicle vaccine against systemic serogroup B meningococcal disease in Norway.

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.

Adolescent↗
PubMed1991

Immunization against serogroup B meningococci. Opsonin response in vaccinees as measured by chemiluminescence.

One hundred and thirteen healthy volunteers were immunized twice (six weeks apart) with four different doses (12.5, 25, 50 and 100 micrograms, measured as protein content) of an outer membrane vesicle vaccine from a serogroup B meningococcal strain (44/76, B:15:P1.16) complexed to serogroup C meningococcal polysaccharide and/or Al(OH)3 i.e. 12 different vaccines. Serum opsonic activity against the serogroup B strain was measured using a chemiluminescence method. A significant rise in serum opsonic activity was demonstrated in 84 volunteers (74%) six weeks after the first injection and in 97 (86%) six weeks after the second. All vaccinees with low preimmunization values (less than 25 mVs) experienced a significant increase in opsonic activity. A dose-related response was most evident for the vaccines containing adjuvant, and these vaccines were associated with a maximum response six weeks after the second injection, while the vaccines without Al(OH)3 induced a peak response six weeks after the first injection. The postimmunization opsonic activity was similar to that found in convalescent sera, indicating that the vaccines may protect against serogroup B meningococcal disease.

Adolescent↗
PubMed1990

[Clinical trials of the new Norwegian vaccine against diseases caused by Meningococcus B].

Since 1974 Norway has experienced an epidemic of meningococcal disease. In October 1986 the National Institute of Public Health decided to develop and test out a vaccine against group B meningococci. This paper describes how the vaccine was tested through phase I and II trials, and how problems of safety and informed consent were handled. Two major protection trials are currently in progress. 130,000 secondary school students have volunteered for a study simulating the use of a vaccine in the long-term protection of an age group at risk. Military recruits are involved in a study where instant protection is important, as in a situation where the vaccine is used in the vicinity of an outbreak of the disease. 20,000 soldiers are included so far, and the study will ultimately include 70,000.

Bacterial Vaccines↗
PubMed1990

Characteristics of serogroup A Neisseria meningitidis responsible for an epidemic in Ethiopia, 1988-89.

In September 1988, an epidemic of meningococcal disease started in Ethiopia. 21 Neisseria meningitidis isolates recovered from patients in Addis Ababa and towns 200 km south of the capital were characterized by serogrouping, serotyping, testing of susceptibility to antibiotics, restriction endonuclease fingerprinting, and multilocus enzyme electrophoresis. The 21 isolates were essentially homogeneous for all properties tested and belonged to clone III-1 of serogroup A N. meningitidis, which was also responsible for the epidemics in Saudi Arabia in 1987 and in Sudan and Chad in 1988.

Adolescent↗