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Journal of Global Health Jun 2019Meningococcal disease continues to be a global public health concern due to its epidemic potential, severity, and sequelae. The global epidemiological data on...
BACKGROUND
Meningococcal disease continues to be a global public health concern due to its epidemic potential, severity, and sequelae. The global epidemiological data on circulating meningococcal serogroups have never been reviewed concurrently with the laboratory capacity for meningococcal surveillance at the national level. We, therefore, aimed to conduct a country-level review of meningococcal surveillance, serogroup distribution, and vaccine use.
METHODS
We conducted a systematic literature review across six databases to identify studies (published January 1, 2010 to October 16, 2017) and grey literature reporting meningococcal serogroup data for the years 2010-2016. We performed independent random effects meta-analyses for serogroups A, B, C, W, X, Y, and other. We developed and circulated a questionnaire-based survey to surveillance focal points in countries (N = 95) with known regional bacterial meningitis surveillance programs to assess their surveillance capacity and summarized using descriptive methods.
RESULTS
We included 173 studies from 59 countries in the final analysis. The distribution of meningococcal serogroups differed markedly between countries and regions. Meningococcal serogroups C and W accounted for substantial proportions of meningococcal disease in most of Africa and Latin America. Serogroup B was the predominant cause of meningococcal disease in many locations in Europe, the Americas, and the Western Pacific. Serogroup Y also caused many cases of meningococcal disease in these regions, particularly in Nordic countries. Survey responses were received from 51 countries. All countries reported the ability to confirm the pathogen in-country, while approximately 30% either relied on reference laboratories for serogrouping (N = 10) or did not serogroup specimens (N = 5). Approximately half of countries did not utilize active laboratory-based surveillance system (N = 22). Nationwide use of a meningococcal vaccine varied, but most countries (N = 36) utilized a meningococcal vaccine at least for certain high-risk population groups, in private care, or during outbreaks.
CONCLUSIONS
Due to the large geographical variations in circulating meningococcal serogroups, each country should continue to be monitored for changes in major disease-causing serogroups in order to inform vaccine and control policies. Similarly, laboratory capacity should be appropriately scaled up to more accurately understand local epidemiology and disease burden, as well as the impact of vaccination programs.
Topics: Global Health; Humans; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis; Population Surveillance; Serogroup; Surveys and Questionnaires
PubMed: 30603079
DOI: 10.7189/jogh.09.010409 -
Expert Review of Vaccines Dec 2018Neisseria meningitidis serogroup B (MenB) is the most common cause of bacterial meningitis in many industrialized countries and occurs at any age. The highest incidence... (Review)
Review
INTRODUCTION
Neisseria meningitidis serogroup B (MenB) is the most common cause of bacterial meningitis in many industrialized countries and occurs at any age. The highest incidence is in infants aged <1 year, followed by children and adolescents. Four-component MenB vaccine (4CMenB, Bexsero) is the only MenB vaccine authorized for use in all age-groups. Experience with 4CMenB is growing as it is implemented in different countries/age-groups encompassing university students, children, adolescents, and infant mass vaccination programs.
AREAS COVERED
An update of recently available data describing the mechanism of immunogenicity of 4CMenB and real-world evidence of vaccine effectiveness and disease impact. We discuss the appropriate age for vaccination to maximize population impacts.
EXPERT COMMENTARY
Invasive meningococcal disease is uncommon and sufficiently powered efficacy studies were not feasible during 4CMenB development. Additionally, several thousand genetically diverse invasive MenB strains circulate globally, varying widely in surface protein expression. This posed significant challenges in predicting clinical protection with MenB vaccines. Five years of 4CMenB use post-licensure confirm the clinical benefit of vaccination as predicted during development. Preliminary evidence suggests an extended impact on other meningococcal serogroups and Neisseria gonorrhoeae.
Topics: Adolescent; Age Factors; Child; Humans; Infant; Meningitis, Meningococcal; Meningococcal Vaccines; Neisseria meningitidis, Serogroup B; Vaccination
PubMed: 30457407
DOI: 10.1080/14760584.2018.1547637 -
The Journal of Infection Dec 2019The Global Meningococcal Initiative (GMI) aims to prevent invasive meningococcal disease (IMD) worldwide through education, research and cooperation. In March 2019, a... (Review)
Review
The Global Meningococcal Initiative (GMI) aims to prevent invasive meningococcal disease (IMD) worldwide through education, research and cooperation. In March 2019, a GMI meeting was held with a multidisciplinary group of experts and representatives from countries within Eastern Europe. Across the countries represented, IMD surveillance is largely in place, with incidence declining in recent decades and now generally at <1 case per 100,000 persons per year. Predominating serogroups are B and C, followed by A, and cases attributable to serogroups W, X and Y are emerging. Available vaccines differ between countries, are generally not included in immunization programs and provided to high-risk groups only. Available vaccines include both conjugate and polysaccharide vaccines; however, current data and GMI recommendations advocate the use of conjugate vaccines, where possible, due to the ability to interrupt the acquisition of carriage. Ongoing carriage studies are expected to inform vaccine effectiveness and immunization schedules. Additionally, IMD prevention and control should be guided by monitoring outbreak progression and the emergence and international spread of strains and antibiotic resistance through use of genomic analyses and implementation of World Health Organization initiatives. Protection of high-risk groups (such as those with complement deficiencies, laboratory workers, migrants and refugees) is recommended.
Topics: Carrier State; Communicable Disease Control; Disease Outbreaks; Disease Transmission, Infectious; Europe, Eastern; Humans; Incidence; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis; Serogroup
PubMed: 31682877
DOI: 10.1016/j.jinf.2019.10.018 -
Anales de Pediatria Dec 2023The main preventive measure against invasive meningococcal disease is vaccination. The aim of our study was to evaluate the acceptability of the meningococcal B (MenB)... (Observational Study)
Observational Study
INTRODUCTION
The main preventive measure against invasive meningococcal disease is vaccination. The aim of our study was to evaluate the acceptability of the meningococcal B (MenB) vaccine and socioeconomic inequalities in the access to the vaccine in the Community of Madrid in the period prior to its introduction in the immunization schedule.
MATERIALS AND METHODS
We conducted an observational and ecological descriptive study in the cohort of children born between 2016 and 2019 using population-based electronic records. We calculated the vaccination coverage and analysed factors associated with vaccination status, determined the spatial distribution of vaccination coverage and the deprivation index (DI) and assessed the association between them by means of spatial regression.
RESULTS
We observed an increasing trend in primary vaccination coverage, from 44% in the cohort born in 2016 to 68% in the 2019 cohort. We found a statistically significant association between vaccination status and the DI (OR of primary vaccination in areas with DI5 compared to areas with DP1, 0.38; 95% confidence interval, 0.39-0.50; P<.001). The spatial analysis showed an inverse correlation between the DI and vaccination coverage.
CONCLUSIONS
The rise in the coverages of the MenB vaccine shows acceptance by the population. The association between socioeconomic level and vaccination coverage confirms the existence of health inequality and underlines the importance including this vaccine in the immunization schedule.
Topics: Child; Humans; Immunization Schedule; Health Status Disparities; Vaccination; Meningococcal Vaccines; Socioeconomic Factors
PubMed: 38016859
DOI: 10.1016/j.anpede.2023.11.006 -
PloS One 2020Typing of Neisseria meningitidis isolates is crucial for the surveillance of invasive meningococcal disease (IMD). We performed a molecular epidemiology study of N....
BACKGROUND
Typing of Neisseria meningitidis isolates is crucial for the surveillance of invasive meningococcal disease (IMD). We performed a molecular epidemiology study of N. meningitidis serogroup B (MenB) causing IMD in Italy between 2014 and 2017 to describe circulating strains belonging to this serogroup, with particular regards to the two factor H-binding protein (FHbp) subfamilies present in the bivalent MenB vaccine.
MATERIALS AND METHODS
A total of 109 culture positive and 46 culture negative MenB samples were collected within the National Surveillance System (NSS) of IMD in Italy and molecularly analyzed by conventional methods.
RESULTS
Overall, 71 MenB samples showed the FHbp subfamily A and 83 the subfamily B. The subfamily variants were differently distributed by age. The most frequent variants, A05 and B231, were associated with cc213 and cc162, respectively. All MenB with the FHbp A05 variant displayed the PorA P1.22,14 and 85.7% of them the FetA F5-5. The majority of MenB with the FHbp B231 variant showed the PorA P1.22,14 (65.4%) and 84.6%, the FetA F3-6.
CONCLUSION
MenB circulating in Italy were characterized by a remarkable association between clonal complex and FHbp variants, although a high degree of genetic diversity observed over time. A dynamic trend in clonal complexes distribution within MenB was detected. Our results stress the importance of continued meningococcal molecular surveillance to evaluate the potential vaccine coverage of the available MenB vaccines.
Topics: Antigens, Bacterial; Bacterial Outer Membrane Proteins; Bacterial Proteins; Bacterial Vaccines; Genetic Variation; Meningococcal Vaccines; Multilocus Sequence Typing; Neisseria meningitidis, Serogroup B; Porins; Software; Whole Genome Sequencing
PubMed: 33176334
DOI: 10.1371/journal.pone.0241793 -
Critical Reviews in Microbiology Feb 2018The majority of invasive meningococcal disease (IMD) in the developed world is caused by capsular group B Neisseria meningitidis, however success with vaccination... (Review)
Review
The majority of invasive meningococcal disease (IMD) in the developed world is caused by capsular group B Neisseria meningitidis, however success with vaccination against organisms bearing this capsule has previously been restricted to control of geographically limited clonal outbreaks. As we enter a new era, with the first routine program underway to control endemic group B meningococcal disease for infants in the UK, it is timely to review the key landmarks in group B vaccine development, and discuss the issues determining whether control of endemic group B disease will be achieved. Evidence of a reduction in carriage acquisition of invasive group B meningococcal strains, after vaccination among adolescents, is imperative if routine immunization is to drive population control of disease beyond those who are vaccinated (i.e. through herd immunity). The need for multiple doses to generate a sufficiently protective response and reactogenicity remain significant problems with the new generation of vaccines. Despite these limitations, early data from the UK indicate that new group B meningococcal vaccines have the potential to have a major impact on meningococcal disease, and to provide new insight into how we might do better in the future.
Topics: Animals; Humans; Meningitis, Meningococcal; Meningococcal Vaccines; Neisseria meningitidis, Serogroup B; Vaccination
PubMed: 28557577
DOI: 10.1080/1040841X.2017.1329276 -
Journal of Clinical Pharmacy and... Aug 2021Patient information leaflets (PILs) or Patient Leaflets (PLs) formally accompany dispensed medicines and are intended to provide the patient with information on how to...
Improving meningococcal MenACWY and 4CMenB/meningococcal group B vaccine-related health literacy in patients: Importance of readability of pharmaceutical Patient Leaflets.
WHAT IS KNOWN AND OBJECTIVE
Patient information leaflets (PILs) or Patient Leaflets (PLs) formally accompany dispensed medicines and are intended to provide the patient with information on how to use the medicine safely. To date, there have been no studies that have examined the readability of meningococcal vaccine patient-facing information, including information contained within the vaccine PIL. Given the role of pharmacists in presenting PILs to patients, it was, therefore, the aim of this study to quantitatively analyse the readability of Patient Leaflets, which accompany licensed meningococcal vaccines in the UK and US and to compare PILs to vaccine pharmaceutical manufacturers' summary of product characteristics (SPC), as well as other patient-facing vaccine-related information.
METHODS
Five sources of meningococcal vaccine information were examined for the licensed meningococcal vaccines in the UK (Bexsero, Menveo, Menitorix, Trumenba, Nimenrix & NeisVac-C) and in the United States (Bexsero, Menveo, Trumenba, Menactra, Menomune-A/C/Y/W-135, Menquadfi), including as follows: (i) SPC (Electronic Medicines Compendium, UK), (ii) Package Insert (FDA; USA), (iii) Patient Leaflet (Electronic Medicines Compendium, UK), (iv) Vaccine pharmaceutical websites and (v) government web resources. Readability was examined employing 10 readability metrics, including the Flesch Reading Ease and the Flesch-Kincaid Grade level.
RESULTS AND DISCUSSION
The information source with the greatest readability scores was the UK Patient Leaflet, which had a mean Flesch Reading Ease score of 58.1 and a mean Flesch-Kincaid Grade score of 7.3, followed by the US Department of Health & Human Services patient-facing website for vaccines (55.9 & 8, respectively), followed by the US Centers for Disease Control and Prevention Vaccine Information Statement (47.3 & 9.4, respectively). Pharmaceutical patient-facing websites for meningococcal vaccines had mean scores of 44.6 and 9.9, respectively. When compared with UK Patient Leaflets, pharmaceutical websites were statistically different with poorer readability with both Flesch Reading Ease and Flesch-Kincaid Grade Level indices (p = 0.02 & p = 0.04, respectively).
WHAT IS NEW AND CONCLUSION
Pharmaceutical meningococcal vaccine PILs were easily read and had statistically significant good readability scores in comparison with vaccine SPCs and US Package Inserts, pharmaceutical product websites and other government patient-facing meningococcal vaccine information. Preparation of patient-facing materials of a complex topic, such as describing meningococcal vaccines, is difficult to accomplish. Although there is a plurality of sources of information through websites and social media, PILs are one of the few sources that are provided directly to patients. This underpins the potential importance of PILs and the importance of their readability. Adoption of readability calculators and scrutiny of materials for their readability will help authors develop materials with improved understanding for vaccine recipients, potentially leading to improved health literacy and vaccine uptake. Renewed efforts should be sought to promote the information within the PIL, thereby maximizing the value of this resource with vaccine recipients, their carers and family.
Topics: Comprehension; Consumer Health Information; Drug Industry; Health Literacy; Humans; Meningococcal Infections; Meningococcal Vaccines; Pamphlets; United Kingdom; United States; Vaccines, Conjugate
PubMed: 33768562
DOI: 10.1111/jcpt.13405 -
BMC Public Health Mar 2023Gonorrhoea is an ongoing public health concern due to its rising incidence and the emergence of antibiotic resistance. There are an estimated 82 million new Neisseria...
An open-label randomised controlled trial evaluating the efficacy of a meningococcal serogroup B (4CMenB) vaccine on Neisseria gonorrhoeae infection in gay and bisexual men: the MenGO study protocol.
BACKGROUND
Gonorrhoea is an ongoing public health concern due to its rising incidence and the emergence of antibiotic resistance. There are an estimated 82 million new Neisseria gonorrhoeae infections each year, with several populations at higher risk for gonococcal infection, including gay and bisexual men (GBM). If left untreated, infection can lead to serious morbidity including infertility, sepsis and increased risk of HIV acquisition. Development of a gonorrhoea vaccine has been challenging, however there is observational evidence that serogroup B meningococcal vaccines, used to protect against the closely related bacteria Neisseria meningitidis, could provide cross-protection against N. gonorrhoeae.
METHODS
The MenGO (Meningococcal vaccine efficacy against Gonorrhoea) study is a phase III open-label randomised control trial in GBM to evaluate the efficacy of the four-component meningococcal serogroup B vaccine, 4CMenB, against gonorrhoea. A total of 130 GBM will be recruited at the Gold Coast Sexual Health Clinic, Australia, and randomised to either receive 2 doses of 4CMenB or no intervention. Participants will be followed up for 24 months with testing for N. gonorrhoeae and other sexually transmissible infections every three months. Demographics, sexual behaviour risk, antibiotic use, and blood samples for analysis of N. gonorrhoeae-specific immune responses, will be collected during the study. The primary outcome is the number of N. gonorrhoeae infections in participants over 2 years measured by nucleic acid amplification test (NAAT). Secondary outcomes are vaccine-induced N. gonorrhoeae-specific immune responses, and adverse events in trial participants.
DISCUSSION
This trial will determine if the 4CMenB vaccine is able to reduce N. gonorrhoeae infection. If shown to be effective, 4CMenB could be used in gonococcal prevention. Analysis of 4CMenB-induced immune responses will increase understanding of the type of immune response needed to prevent N. gonorrhoeae, which may enable identification of a potential correlate of protection to aid future gonorrhoea vaccine development.
TRIAL REGISTRATION
The trial has been registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12619001478101) on 25 October 2019.
Topics: Humans; Male; Australia; Clinical Trials, Phase III as Topic; Gonorrhea; Meningococcal Infections; Meningococcal Vaccines; Neisseria gonorrhoeae; Neisseria meningitidis, Serogroup B; Randomized Controlled Trials as Topic; Serogroup; Sexual and Gender Minorities; Sexual Behavior
PubMed: 36997957
DOI: 10.1186/s12889-023-15516-y -
Drugs Nov 2017MenACWY-TT (Nimenrix) is a quadrivalent meningococcal tetanus toxoid conjugate vaccine licensed in Europe for active immunisation of individuals aged ≥ 6 weeks... (Review)
Review
MenACWY-TT (Nimenrix) is a quadrivalent meningococcal tetanus toxoid conjugate vaccine licensed in Europe for active immunisation of individuals aged ≥ 6 weeks against invasive disease caused by Neisseria meningitidis capsular groups A, C, W and Y. MenACWY-TT is the first quadrivalent conjugate vaccine to be approved in Europe for use in infants as young as 6 weeks of age. Numerous phase II-IIIb clinical studies showed that intramuscular MenACWY-TT administered as primary or booster vaccination was highly immunogenic for all four vaccine capsular groups and had an acceptable reactogenicity profile in individuals aged 6 weeks to ≥ 56 years. MenACWY-TT is as immunogenic and safe as other previously licensed monovalent capsular group C or quadrivalent capsular groups A, C, W and Y meningococcal vaccines and can be coadministered with other routine vaccines without adversely affecting the immunogenicity or safety profiles of either vaccine. Current data indicate that primary and booster vaccination with MenACWY-TT is a valuable and safe option for broadening meningococcal protection against four capsular groups across a broad age range, starting as early as 6 weeks of age.
Topics: Europe; Humans; Immunization, Secondary; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis; Vaccination; Vaccines, Conjugate
PubMed: 29094312
DOI: 10.1007/s40265-017-0828-8 -
Clinical Infectious Diseases : An... Nov 2015Group A Neisseria meningitidis has been a major cause of bacterial meningitis in the sub-Saharan region of Africa in the meningitis belt. Neisseria meningitidis is an... (Review)
Review
BACKGROUND
Group A Neisseria meningitidis has been a major cause of bacterial meningitis in the sub-Saharan region of Africa in the meningitis belt. Neisseria meningitidis is an encapsulated pathogen, and antibodies against the capsular polysaccharide are protective. Polysaccharide-protein conjugate vaccines have proven to be highly effective against several different encapsulated bacterial pathogens. Purified polysaccharide vaccines have been used to control group A meningococcal (MenA) epidemics with minimal success.
METHODS
A monovalent MenA polysaccharide-tetanus toxoid conjugate was therefore developed. This vaccine was developed by scientists working with the Meningitis Vaccine Project, a partnership between PATH and the World Health Organization.
RESULTS
A high-efficiency conjugation method was developed in the Laboratory of Bacterial Polysaccharides in the Center for Biologics Evaluation and Research and transferred to the Serum Institute of India, Ltd, which then developed methods for purification of the group A polysaccharide and used its tetanus toxoid as the carrier protein to produce the now-licensed, highly effective MenAfriVac conjugate vaccine.
CONCLUSIONS
Although many years of application of meningococcal polysaccharide vaccines have had minimal success in preventing meningococcal epidemics in the meningitis belt of Africa, our collaborative efforts to develop a MenA conjugate vaccine yielded a safe and highly effective vaccine.
Topics: Africa South of the Sahara; Disease Transmission, Infectious; Humans; India; International Cooperation; Meningitis, Meningococcal; Meningococcal Vaccines; Neisseria meningitidis, Serogroup A; Technology, Pharmaceutical; World Health Organization
PubMed: 26553667
DOI: 10.1093/cid/civ595