Berit Feiring - Academia.edu (original) (raw)
Papers by Berit Feiring
Source at https://www.helsebiblioteket.no/Denne rapporten er første del av et oppdrag fra Nasjona... more Source at https://www.helsebiblioteket.no/Denne rapporten er første del av et oppdrag fra Nasjonalt folkehelseinstitutt, med fokus på vurdering av effekt og sikkerhet ved bruk av vaksiner mot humant papillomavirus (HPV). Det pågår helseøkonomiske analyser som publiseres i en egen rapport.The Norwegian Knowledge Centre for the Health Service (NOKC) was requested by the Norwegian Institute of Public Health to do a health technology assessment (HTA) on the effectiveness of prophylactic vaccines against human papillomavirus (HPV) infection. This part of the report, has evaluated the effectiveness and safety of such vaccines. Part two evaluates the cost-effectiveness and will be published at a later stage
Clinical Epidemiology, Apr 1, 2022
Comparing rates of childhood infectious disease hospitalisations across countries may uncover are... more Comparing rates of childhood infectious disease hospitalisations across countries may uncover areas for improvement in the prevention of severe childhood infections. We compared rates of childhood infectious disease hospital contacts across Denmark, Finland, Norway, and Sweden with the overall objective to elucidate potential differences in burden of disease and in organisational and registration practices. Methods: Using national registries, we estimated incidence rates for infectious disease hospital contacts between 2008 and 2017 among children aged 0-14 years. We investigated the rates for different types of contacts (inpatient or outpatient including emergency room), duration of admission, and by sex. Results: During the study period, the rate of all hospital contacts per 1000 person-years was highest in Sweden (125.2) followed by Finland (87.1), Denmark (79.0), and Norway (62.1). The rates aligned for inpatient contacts with overnight stays; 19.3 (Denmark), 16.6 (Finland), 16.3 (Norway), and 13.0 (Sweden); these were highest in early infancy in all countries. A peak around 1 year of age was seen in all countries except in Sweden. The rates were higher among boys compared with girls in early childhood, after 13 years of age the rates among girls surpassed the boys. Conclusion: Large crosscountry differences were observed for outpatient and short-term hospital contacts for infectious diseases, affected by differences in organisational structures and coding practices across and within countries over time. Inpatient contacts requiring overnight stays reflected more comparable levels of severe infections across countries. Childhood infectious disease morbidity was greatest among boys and before 2 years of age.
Weekly releases (1997–2007), Feb 2, 2006
Pneumococcal conjugate vaccine is being added to the routine childhood vaccination programme in N... more Pneumococcal conjugate vaccine is being added to the routine childhood vaccination programme in Norway, after a decision by the Norwegian government.
PubMed, May 10, 2001
Background: A study comparing diphtheria immunity in Norwegian and Russian schoolchildren indicat... more Background: A study comparing diphtheria immunity in Norwegian and Russian schoolchildren indicated low immunity against diphtheria in Norwegian children before the booster dose given at age 11 years. The pertussis epidemic in Norway 1997-98 demonstrated decreasing vaccine immunity from age 5-6 years. The possibility of improving immunity against both diseases by a booster dose during early school age is therefore under consideration. Material and methods: Immune response and adverse events were studied after a combined vaccine against diphtheria, tetanus, pertussis (acellular) and poliomyelitis (DTPa-IPV) given at seven years of age, and a combined vaccine against diphtheria, tetanus and pertussis (acellular) (DTPa) at 11 years of age, in two parallel trials including 124 and 83 participants respectively. Results: The trials confirmed that the diphtheria immunity is lower than it ideally should be in more than 40% of children before the booster dose at age 11. Pertussis immunity is difficult to assess because there is no clear relationship between antibody levels and protection. All study participants responded well to all vaccine components. The 11-year-old children reported higher occurrence of adverse events than the 7-year-olds. All adverse events were brief and none were serious. Interpretation: The results indicate that a booster dose of DTPa-IPV in early school age would give better protection against diphtheria and pertussis in Norwegian schoolchildren, without unacceptable side effects.
PubMed, Jan 30, 1989
We surveyed clinical trials of anti-tumour drugs notified to the Norwegian Medicines Control Auth... more We surveyed clinical trials of anti-tumour drugs notified to the Norwegian Medicines Control Authority during the period 1982 to 1986. 91 trials of anti-tumour drugs were notified during the period. A relatively large number of the trials were carried out without a control group, and a statistical rationale for the number of patients was lacking in almost 60% of the protocols. In 40% of the notified trials the manufacturers were not involved. Records of written information to patients have improved, as has insurance of the patients. On the other hand, reports on ongoing and completed clinical trials are still too often neglected.
PubMed, Jan 30, 1989
During the five-year period 1982-86, 1,087 clinical drug trials were notified to the Norwegian Me... more During the five-year period 1982-86, 1,087 clinical drug trials were notified to the Norwegian Medicines Control Authority. There was in this period a slight decline in the annual number of notifications, whereas the number of patients/volunteer subjects in clinical trials rose. During the five-year period, every fifth professionally active physician in Norway notified at least one clinical trial to the Authority. Less than 10% of the trials notified did not involve participation by manufacturers. The trials covered a large number of substances. Most trials concerned drugs in the cardiovascular (c) and central nervous system (N) therapeutic groups. The frequency of reports on completed trials is low, and there are signs that some obligatory notifications of clinical trials are not sent to the Authority.
Tidsskrift for Den Norske Laegeforening, Oct 5, 2006
Clinical Epidemiology, Aug 1, 2022
To compare the use of antibiotics in children in four Northern European countries. Methods: We co... more To compare the use of antibiotics in children in four Northern European countries. Methods: We conducted a register-based study based on individual-level prescription data from national prescription registers. We identified all redeemed outpatient prescriptions for systemic antibiotics in children aged 0-14 years from July 2006 to June 2017 in Denmark, Finland, Norway, and Sweden. We computed incidence rates and incidence rate ratios of treatment episodes with any antibiotic and different antibiotic classes.
PubMed, Dec 1, 1991
Antibody responses after vaccination with three different formulations of a new meningococcal gro... more 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.
Vaccine, Jan 30, 2003
For evaluation of serum bactericidal activity (SBA) as surrogate for the efficacy of outer membra... more For evaluation of serum bactericidal activity (SBA) as surrogate for the efficacy of outer membrane vesicle (OMV) vaccines against Neisseria meningitidis serogroup B disease, we have reanalyzed data from a randomized double blind placebo-controlled efficacy trial involving 172,000 secondary school students (aged 13-14 years) in Norway (1988-1991). A cohort of the efficacy trial consisting of 880 individuals was selected for immunogenicity studies. An efficacy of 87% was calculated for a 10-month observation period. However, after an observation period of 29 months, the estimated efficacy against group B disease induced by vaccination was 57%. The immunogenicity study showed that the SBA geometric mean titer (GMT) for the vaccinees was 2.4 before vaccination and 19.0 six weeks after the second vaccine dose. One year after vaccination the GMT was reduced to 2.8. A separate three-dose study with 304 adolescents showed that with a third dose at 10 months after the second dose (i.e. when cases of disease started to appear) a strong booster response was induced. Ten months after the second dose the SBA was reduced to near pre-immunization level. Following the third dose the SBA geometric mean titer of 2.7 increased to 62.3. One year after the third dose, the GMT was markedly higher than 6 weeks after the second dose (12.6 versus 8.8). Thus, protection after vaccination corresponds with the level of SBA. In order to reach lasting protective levels of SBA in a population, three vaccine doses are probably required. Measurements of SBA are likely to be useful for evaluating various upcoming formulations and improvements of immunization regimens for OMV vaccines.
The Journal of Infectious Diseases, Nov 17, 2020
Background. Whether type-specific human papillomavirus (HPV) infection influences the risk of acq... more Background. Whether type-specific human papillomavirus (HPV) infection influences the risk of acquiring infections with other HPV types is unclear. We studied concurrent HPV infections in 17-year-old girls from 2 birth cohorts; the first vaccine-eligible cohort in Norway and a prevaccination cohort. Methods. Urine samples were collected and tested for 37 HPV genotypes. This study was restricted to unvaccinated girls from the prevaccination cohort (n = 5245) and vaccinated girls from the vaccine-eligible cohort (n = 4904). Risk of HPV infection was modelled using mixed-effect logistic regression. Expected frequencies of concurrent infection with each pairwise combination of the vaccine types and high-risk types (
Papillomavirus Research, Dec 1, 2016
Background: The aim of the current study was to assess the HPV prevalence in unscreened and unvac... more Background: The aim of the current study was to assess the HPV prevalence in unscreened and unvaccinated young women living in Norway, to provide important baseline data for early estimation of the impact of the HPV vaccination program. Methods: A total of 13,129 self-sampled urine samples from two complete birth-cohorts of 17-year old women born in 1994 and 1996 and one third of a birth-cohort of 21-year old women born in 1990, were analysed for the presence of 37 HPV types using PCR and a DNA hybridization technique. Results: In the two birth cohorts of 17-year old women, HPV was detected in 19.9% (95% CI 18.8-20.9) and 15.4% (95% CI 14.5-16.3), respectively. High-risk HPV types were detected in 11.2% (95% CI 10.3-12.0) and 7.6% (95% CI 6.9-8.2), respectively, while vaccine types were detected in 7.4% (95% CI 6.7-8.1) and 6.0% (95% CI 5.4-6.6), respectively. Among the 21-year old women HPV was detected in 45.4% (95% CI 42.9-47.8), whereas high-risk types were detected in 29.8% (95% CI 27.5-32.0). Vaccine types (HPV 6, 11, 16, 18) were detected in 16.2% (95% CI 14.4-18.1). Conclusion: This large population based study confirms that HPV testing in urine samples is easy and highly feasible for epidemiological studies and vaccine surveillance in young women. HPV was very common and a broad spectrum of HPV types was identified. Differences in HPV prevalence was seen both between age groups and between the two birth cohorts of 17-year old women.
Clinical and Vaccine Immunology, May 1, 2005
MenBvac and Menjugate are safe and efficacious vaccines. The purpose of this study was to evaluat... more MenBvac and Menjugate are safe and efficacious vaccines. The purpose of this study was to evaluate safety and immunogenicity of the combination (MenB/C) of the lyophilized active components of the conjugated group C vaccine Menjugate when reconstituted with the full liquid group B outer membrane vesicle vaccine MenBvac compared to MenBvac and Menjugate given separately. At 6-week intervals, healthy adults were given one dose of MenB/C followed by two doses of MenBvac (MenB/C group), three doses of MenBvac (MenB group), or one dose of Menjugate and two doses of placebo (MenC group). Injection site reactions were frequent in all groups. However, most reactions were short lasting and mild or moderate in intensity, and the vaccines were found to be well tolerated, with no vaccine-related serious adverse events. MenB/C was immunogenic with regard to both serogroup B and C meningococci. Both the serum bactericidal assay and the enzyme-linked immunosorbent assay analyses showed that the immune responses of the combination vaccine were similar to the immune responses of its separate components MenBvac and Menjugate for both serogroup B and C. In conclusion, the combined MenB/C vaccine is safe and immunogenic. The two vaccines do not interact negatively with each other and can easily be administered in the same syringe. The induced immune responses suggest that the combined vaccine is likely to confer protection against systemic group B disease caused by the vaccine strain as well as against group C meningococcal disease.
Vaccine, Apr 1, 2007
MenBvac is an OMV vaccine against systemic serogroup B Neisseria meningitidis disease. MenBvac wa... more MenBvac is an OMV vaccine against systemic serogroup B Neisseria meningitidis disease. MenBvac was developed for control of a B:15:P1.7,16 subtype epidemic in Norway and administered to 180,000 subjects in 28 clinical studies. MeNZB, a daughter vaccine of MenBvac, was developed for a clonal B:4:P1.7b,4 epidemic in New Zealand and administered to 1 million people <20 years. The vaccines were similar regarding reactogenicity profile. Serious adverse events (SAEs) in general and particularly neurologic SAEs were very rare. Despite frequently reported local reactions and fever in those under 5 years, these OMV-based vaccines containing 25 microg antigen can be considered safe for use in all age groups.
BMJ Medicine, Oct 1, 2022
BMC Infectious Diseases, Mar 20, 2012
Background: During the 2009-2010 pandemic in Norway, 12 513 laboratory-confirmed cases of pandemi... more Background: During the 2009-2010 pandemic in Norway, 12 513 laboratory-confirmed cases of pandemic influenza A(H1N1)pdm09, were reported to the Norwegian Surveillance System for Communicable Diseases (MSIS). 2.2 million persons (45% of the population) were vaccinated with an AS03-adjuvanted monovalent vaccine during the pandemic. Most of them were registered in the Norwegian Immunisation Registry (SYSVAK). Based on these registries, we aimed at estimating the vaccine effectiveness (VE) and describing vaccine failures during the pandemic in Norway, in order to evaluate the role of the vaccine as a preventive measure during the pandemic. Methods: We conducted a population-based retrospective cohort study, linking MSIS and SYSVAK with pandemic influenza vaccination as exposure and laboratory-confirmed pandemic influenza as outcome. We measured VE by week and defined two thresholds for immunity; eight and 15 days after vaccination. Results: The weekly VE ranged from 77% to 96% when considering 15 days or more after vaccination as the threshold of immunity and from 73% to 94% when considering eight days or more. Overall, 157 individuals contracted pandemic influenza eight or more days after vaccination (8.4/100,000 vaccinated), of these 58 had onset 15 days or more after vaccination (3.0/100,000 vaccinated). Most of the vaccine failures occurred during the first weeks of the vaccination campaign. More than 30% of the vaccine failures were found in people below 10 years of age. Conclusions: Having available health registries with data regarding cases of specific disease and vaccination makes it feasible to estimate VE in a simple and rapid way. VE was high regardless the immunity threshold chosen. We encourage public health authorities in other countries to set up such registries. It is also important to consider including information on underlying diseases in registries already existing, in order to make it feasible to conduct more complete VE estimations.
PubMed, Dec 1, 1991
In order to establish the safety of the Norwegian meningococcus B vaccine we have focused on deta... more 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.
BMJ Open, Feb 1, 2023
The aim of the NONSEnse project is to investigate the non-specific effects of vaccines and immuni... more The aim of the NONSEnse project is to investigate the non-specific effects of vaccines and immunisation programmes on the overall health of children by using information from the extensive nationwide registers on health and sociodemographic factors in Denmark, Finland, Norway and Sweden. Participants The cohort covers 9 072 420 children aged 0-17 years, born 1990-2017/2018 and living in Denmark, Finland, Norway or Sweden. All countries use a unique identification number for its permanent residents, which makes it possible to link individual-level information from different registers. Findings to date Data collection and harmonisation according to a common data model was completed in March 2022. As a prerequisite for comparing the effects of childhood vaccinations on the overall health of children across the Nordic countries, we have identified indicators measuring similar levels of infectious disease morbidity across these settings. So far, studies pertaining to nonspecific effects of vaccines are limited to investigations that could be undertaken using aggregated data sets that were available before the NONSEnse cohort with individual-level information was completely set up. Future plans We are currently performing several studies of the effects on non-targeted infectious disease morbidity across the countries following vaccination against measles, mumps, rubella, diphtheria, tetanus, pertussis, human papillomavirus, rotavirus and influenza. Multiple studies are planned within the next years using different study designs to facilitate triangulation of results and enhance causal inference. Registration No clinical trials will be conducted within the NONSEnse project.
Source at https://www.helsebiblioteket.no/Denne rapporten er første del av et oppdrag fra Nasjona... more Source at https://www.helsebiblioteket.no/Denne rapporten er første del av et oppdrag fra Nasjonalt folkehelseinstitutt, med fokus på vurdering av effekt og sikkerhet ved bruk av vaksiner mot humant papillomavirus (HPV). Det pågår helseøkonomiske analyser som publiseres i en egen rapport.The Norwegian Knowledge Centre for the Health Service (NOKC) was requested by the Norwegian Institute of Public Health to do a health technology assessment (HTA) on the effectiveness of prophylactic vaccines against human papillomavirus (HPV) infection. This part of the report, has evaluated the effectiveness and safety of such vaccines. Part two evaluates the cost-effectiveness and will be published at a later stage
Clinical Epidemiology, Apr 1, 2022
Comparing rates of childhood infectious disease hospitalisations across countries may uncover are... more Comparing rates of childhood infectious disease hospitalisations across countries may uncover areas for improvement in the prevention of severe childhood infections. We compared rates of childhood infectious disease hospital contacts across Denmark, Finland, Norway, and Sweden with the overall objective to elucidate potential differences in burden of disease and in organisational and registration practices. Methods: Using national registries, we estimated incidence rates for infectious disease hospital contacts between 2008 and 2017 among children aged 0-14 years. We investigated the rates for different types of contacts (inpatient or outpatient including emergency room), duration of admission, and by sex. Results: During the study period, the rate of all hospital contacts per 1000 person-years was highest in Sweden (125.2) followed by Finland (87.1), Denmark (79.0), and Norway (62.1). The rates aligned for inpatient contacts with overnight stays; 19.3 (Denmark), 16.6 (Finland), 16.3 (Norway), and 13.0 (Sweden); these were highest in early infancy in all countries. A peak around 1 year of age was seen in all countries except in Sweden. The rates were higher among boys compared with girls in early childhood, after 13 years of age the rates among girls surpassed the boys. Conclusion: Large crosscountry differences were observed for outpatient and short-term hospital contacts for infectious diseases, affected by differences in organisational structures and coding practices across and within countries over time. Inpatient contacts requiring overnight stays reflected more comparable levels of severe infections across countries. Childhood infectious disease morbidity was greatest among boys and before 2 years of age.
Weekly releases (1997–2007), Feb 2, 2006
Pneumococcal conjugate vaccine is being added to the routine childhood vaccination programme in N... more Pneumococcal conjugate vaccine is being added to the routine childhood vaccination programme in Norway, after a decision by the Norwegian government.
PubMed, May 10, 2001
Background: A study comparing diphtheria immunity in Norwegian and Russian schoolchildren indicat... more Background: A study comparing diphtheria immunity in Norwegian and Russian schoolchildren indicated low immunity against diphtheria in Norwegian children before the booster dose given at age 11 years. The pertussis epidemic in Norway 1997-98 demonstrated decreasing vaccine immunity from age 5-6 years. The possibility of improving immunity against both diseases by a booster dose during early school age is therefore under consideration. Material and methods: Immune response and adverse events were studied after a combined vaccine against diphtheria, tetanus, pertussis (acellular) and poliomyelitis (DTPa-IPV) given at seven years of age, and a combined vaccine against diphtheria, tetanus and pertussis (acellular) (DTPa) at 11 years of age, in two parallel trials including 124 and 83 participants respectively. Results: The trials confirmed that the diphtheria immunity is lower than it ideally should be in more than 40% of children before the booster dose at age 11. Pertussis immunity is difficult to assess because there is no clear relationship between antibody levels and protection. All study participants responded well to all vaccine components. The 11-year-old children reported higher occurrence of adverse events than the 7-year-olds. All adverse events were brief and none were serious. Interpretation: The results indicate that a booster dose of DTPa-IPV in early school age would give better protection against diphtheria and pertussis in Norwegian schoolchildren, without unacceptable side effects.
PubMed, Jan 30, 1989
We surveyed clinical trials of anti-tumour drugs notified to the Norwegian Medicines Control Auth... more We surveyed clinical trials of anti-tumour drugs notified to the Norwegian Medicines Control Authority during the period 1982 to 1986. 91 trials of anti-tumour drugs were notified during the period. A relatively large number of the trials were carried out without a control group, and a statistical rationale for the number of patients was lacking in almost 60% of the protocols. In 40% of the notified trials the manufacturers were not involved. Records of written information to patients have improved, as has insurance of the patients. On the other hand, reports on ongoing and completed clinical trials are still too often neglected.
PubMed, Jan 30, 1989
During the five-year period 1982-86, 1,087 clinical drug trials were notified to the Norwegian Me... more During the five-year period 1982-86, 1,087 clinical drug trials were notified to the Norwegian Medicines Control Authority. There was in this period a slight decline in the annual number of notifications, whereas the number of patients/volunteer subjects in clinical trials rose. During the five-year period, every fifth professionally active physician in Norway notified at least one clinical trial to the Authority. Less than 10% of the trials notified did not involve participation by manufacturers. The trials covered a large number of substances. Most trials concerned drugs in the cardiovascular (c) and central nervous system (N) therapeutic groups. The frequency of reports on completed trials is low, and there are signs that some obligatory notifications of clinical trials are not sent to the Authority.
Tidsskrift for Den Norske Laegeforening, Oct 5, 2006
Clinical Epidemiology, Aug 1, 2022
To compare the use of antibiotics in children in four Northern European countries. Methods: We co... more To compare the use of antibiotics in children in four Northern European countries. Methods: We conducted a register-based study based on individual-level prescription data from national prescription registers. We identified all redeemed outpatient prescriptions for systemic antibiotics in children aged 0-14 years from July 2006 to June 2017 in Denmark, Finland, Norway, and Sweden. We computed incidence rates and incidence rate ratios of treatment episodes with any antibiotic and different antibiotic classes.
PubMed, Dec 1, 1991
Antibody responses after vaccination with three different formulations of a new meningococcal gro... more 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.
Vaccine, Jan 30, 2003
For evaluation of serum bactericidal activity (SBA) as surrogate for the efficacy of outer membra... more For evaluation of serum bactericidal activity (SBA) as surrogate for the efficacy of outer membrane vesicle (OMV) vaccines against Neisseria meningitidis serogroup B disease, we have reanalyzed data from a randomized double blind placebo-controlled efficacy trial involving 172,000 secondary school students (aged 13-14 years) in Norway (1988-1991). A cohort of the efficacy trial consisting of 880 individuals was selected for immunogenicity studies. An efficacy of 87% was calculated for a 10-month observation period. However, after an observation period of 29 months, the estimated efficacy against group B disease induced by vaccination was 57%. The immunogenicity study showed that the SBA geometric mean titer (GMT) for the vaccinees was 2.4 before vaccination and 19.0 six weeks after the second vaccine dose. One year after vaccination the GMT was reduced to 2.8. A separate three-dose study with 304 adolescents showed that with a third dose at 10 months after the second dose (i.e. when cases of disease started to appear) a strong booster response was induced. Ten months after the second dose the SBA was reduced to near pre-immunization level. Following the third dose the SBA geometric mean titer of 2.7 increased to 62.3. One year after the third dose, the GMT was markedly higher than 6 weeks after the second dose (12.6 versus 8.8). Thus, protection after vaccination corresponds with the level of SBA. In order to reach lasting protective levels of SBA in a population, three vaccine doses are probably required. Measurements of SBA are likely to be useful for evaluating various upcoming formulations and improvements of immunization regimens for OMV vaccines.
The Journal of Infectious Diseases, Nov 17, 2020
Background. Whether type-specific human papillomavirus (HPV) infection influences the risk of acq... more Background. Whether type-specific human papillomavirus (HPV) infection influences the risk of acquiring infections with other HPV types is unclear. We studied concurrent HPV infections in 17-year-old girls from 2 birth cohorts; the first vaccine-eligible cohort in Norway and a prevaccination cohort. Methods. Urine samples were collected and tested for 37 HPV genotypes. This study was restricted to unvaccinated girls from the prevaccination cohort (n = 5245) and vaccinated girls from the vaccine-eligible cohort (n = 4904). Risk of HPV infection was modelled using mixed-effect logistic regression. Expected frequencies of concurrent infection with each pairwise combination of the vaccine types and high-risk types (
Papillomavirus Research, Dec 1, 2016
Background: The aim of the current study was to assess the HPV prevalence in unscreened and unvac... more Background: The aim of the current study was to assess the HPV prevalence in unscreened and unvaccinated young women living in Norway, to provide important baseline data for early estimation of the impact of the HPV vaccination program. Methods: A total of 13,129 self-sampled urine samples from two complete birth-cohorts of 17-year old women born in 1994 and 1996 and one third of a birth-cohort of 21-year old women born in 1990, were analysed for the presence of 37 HPV types using PCR and a DNA hybridization technique. Results: In the two birth cohorts of 17-year old women, HPV was detected in 19.9% (95% CI 18.8-20.9) and 15.4% (95% CI 14.5-16.3), respectively. High-risk HPV types were detected in 11.2% (95% CI 10.3-12.0) and 7.6% (95% CI 6.9-8.2), respectively, while vaccine types were detected in 7.4% (95% CI 6.7-8.1) and 6.0% (95% CI 5.4-6.6), respectively. Among the 21-year old women HPV was detected in 45.4% (95% CI 42.9-47.8), whereas high-risk types were detected in 29.8% (95% CI 27.5-32.0). Vaccine types (HPV 6, 11, 16, 18) were detected in 16.2% (95% CI 14.4-18.1). Conclusion: This large population based study confirms that HPV testing in urine samples is easy and highly feasible for epidemiological studies and vaccine surveillance in young women. HPV was very common and a broad spectrum of HPV types was identified. Differences in HPV prevalence was seen both between age groups and between the two birth cohorts of 17-year old women.
Clinical and Vaccine Immunology, May 1, 2005
MenBvac and Menjugate are safe and efficacious vaccines. The purpose of this study was to evaluat... more MenBvac and Menjugate are safe and efficacious vaccines. The purpose of this study was to evaluate safety and immunogenicity of the combination (MenB/C) of the lyophilized active components of the conjugated group C vaccine Menjugate when reconstituted with the full liquid group B outer membrane vesicle vaccine MenBvac compared to MenBvac and Menjugate given separately. At 6-week intervals, healthy adults were given one dose of MenB/C followed by two doses of MenBvac (MenB/C group), three doses of MenBvac (MenB group), or one dose of Menjugate and two doses of placebo (MenC group). Injection site reactions were frequent in all groups. However, most reactions were short lasting and mild or moderate in intensity, and the vaccines were found to be well tolerated, with no vaccine-related serious adverse events. MenB/C was immunogenic with regard to both serogroup B and C meningococci. Both the serum bactericidal assay and the enzyme-linked immunosorbent assay analyses showed that the immune responses of the combination vaccine were similar to the immune responses of its separate components MenBvac and Menjugate for both serogroup B and C. In conclusion, the combined MenB/C vaccine is safe and immunogenic. The two vaccines do not interact negatively with each other and can easily be administered in the same syringe. The induced immune responses suggest that the combined vaccine is likely to confer protection against systemic group B disease caused by the vaccine strain as well as against group C meningococcal disease.
Vaccine, Apr 1, 2007
MenBvac is an OMV vaccine against systemic serogroup B Neisseria meningitidis disease. MenBvac wa... more MenBvac is an OMV vaccine against systemic serogroup B Neisseria meningitidis disease. MenBvac was developed for control of a B:15:P1.7,16 subtype epidemic in Norway and administered to 180,000 subjects in 28 clinical studies. MeNZB, a daughter vaccine of MenBvac, was developed for a clonal B:4:P1.7b,4 epidemic in New Zealand and administered to 1 million people <20 years. The vaccines were similar regarding reactogenicity profile. Serious adverse events (SAEs) in general and particularly neurologic SAEs were very rare. Despite frequently reported local reactions and fever in those under 5 years, these OMV-based vaccines containing 25 microg antigen can be considered safe for use in all age groups.
BMJ Medicine, Oct 1, 2022
BMC Infectious Diseases, Mar 20, 2012
Background: During the 2009-2010 pandemic in Norway, 12 513 laboratory-confirmed cases of pandemi... more Background: During the 2009-2010 pandemic in Norway, 12 513 laboratory-confirmed cases of pandemic influenza A(H1N1)pdm09, were reported to the Norwegian Surveillance System for Communicable Diseases (MSIS). 2.2 million persons (45% of the population) were vaccinated with an AS03-adjuvanted monovalent vaccine during the pandemic. Most of them were registered in the Norwegian Immunisation Registry (SYSVAK). Based on these registries, we aimed at estimating the vaccine effectiveness (VE) and describing vaccine failures during the pandemic in Norway, in order to evaluate the role of the vaccine as a preventive measure during the pandemic. Methods: We conducted a population-based retrospective cohort study, linking MSIS and SYSVAK with pandemic influenza vaccination as exposure and laboratory-confirmed pandemic influenza as outcome. We measured VE by week and defined two thresholds for immunity; eight and 15 days after vaccination. Results: The weekly VE ranged from 77% to 96% when considering 15 days or more after vaccination as the threshold of immunity and from 73% to 94% when considering eight days or more. Overall, 157 individuals contracted pandemic influenza eight or more days after vaccination (8.4/100,000 vaccinated), of these 58 had onset 15 days or more after vaccination (3.0/100,000 vaccinated). Most of the vaccine failures occurred during the first weeks of the vaccination campaign. More than 30% of the vaccine failures were found in people below 10 years of age. Conclusions: Having available health registries with data regarding cases of specific disease and vaccination makes it feasible to estimate VE in a simple and rapid way. VE was high regardless the immunity threshold chosen. We encourage public health authorities in other countries to set up such registries. It is also important to consider including information on underlying diseases in registries already existing, in order to make it feasible to conduct more complete VE estimations.
PubMed, Dec 1, 1991
In order to establish the safety of the Norwegian meningococcus B vaccine we have focused on deta... more 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.
BMJ Open, Feb 1, 2023
The aim of the NONSEnse project is to investigate the non-specific effects of vaccines and immuni... more The aim of the NONSEnse project is to investigate the non-specific effects of vaccines and immunisation programmes on the overall health of children by using information from the extensive nationwide registers on health and sociodemographic factors in Denmark, Finland, Norway and Sweden. Participants The cohort covers 9 072 420 children aged 0-17 years, born 1990-2017/2018 and living in Denmark, Finland, Norway or Sweden. All countries use a unique identification number for its permanent residents, which makes it possible to link individual-level information from different registers. Findings to date Data collection and harmonisation according to a common data model was completed in March 2022. As a prerequisite for comparing the effects of childhood vaccinations on the overall health of children across the Nordic countries, we have identified indicators measuring similar levels of infectious disease morbidity across these settings. So far, studies pertaining to nonspecific effects of vaccines are limited to investigations that could be undertaken using aggregated data sets that were available before the NONSEnse cohort with individual-level information was completely set up. Future plans We are currently performing several studies of the effects on non-targeted infectious disease morbidity across the countries following vaccination against measles, mumps, rubella, diphtheria, tetanus, pertussis, human papillomavirus, rotavirus and influenza. Multiple studies are planned within the next years using different study designs to facilitate triangulation of results and enhance causal inference. Registration No clinical trials will be conducted within the NONSEnse project.