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Expert Review of Vaccines 2023Invasive meningococcal disease (IMD) is a major health concern which can be prevented through vaccination. Conjugate vaccines against serogroups A, C, W, and Y and two... (Review)
Review
INTRODUCTION
Invasive meningococcal disease (IMD) is a major health concern which can be prevented through vaccination. Conjugate vaccines against serogroups A, C, W, and Y and two protein-based vaccines against serogroup B are currently available in the European Union.
AREAS COVERED
We present epidemiologic data for Italy, Portugal, Greece, and Spain using publicly available reports from national reference laboratories and national or regional immunization programs (1999-2019), aiming to confirm risk groups, and describe time trends in overall incidence and serogroup distribution, as well as impact of immunization. Analysis of circulating MenB isolates in terms of the surface factor H binding protein (fHbp) using PubMLST is discussed as fHbp represents an important MenB vaccine antigen. Predictions of potential reactivity of the two available MenB vaccines (MenB-fHbp and 4CMenB) with circulating MenB isolates are also provided as assessed using the recently developed MenDeVAR tool.
EXPERT OPINION
Understanding dynamics of IMD and continued genomic surveillance are essential for evaluating vaccine effectiveness, but also prompting proactive immunization programs to prevent future outbreaks. Importantly, the successful design of further effective meningococcal vaccines to fight IMD relies on considering the unpredictable epidemiology of the disease and combining lessons learnt from capsule polysaccharide vaccines and protein-based vaccines.
Topics: Humans; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis, Serogroup B; Vaccination; Antigens, Bacterial; Serogroup; Carrier Proteins
PubMed: 37316234
DOI: 10.1080/14760584.2023.2225596 -
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 -
Expert Review of Vaccines 2024The epidemiology of invasive meningococcal disease (IMD), a rare but potentially fatal illness, is typically described as unpredictable and subject to sporadic outbreaks. (Review)
Review
INTRODUCTION
The epidemiology of invasive meningococcal disease (IMD), a rare but potentially fatal illness, is typically described as unpredictable and subject to sporadic outbreaks.
AREAS COVERED
Meningococcal epidemiology and vaccine use during the last ~ 200 years are examined within the context of meningococcal characterization and classification to guide future IMD prevention efforts.
EXPERT OPINION
Historical and contemporary data highlight the dynamic nature of meningococcal epidemiology, with continued emergence of hyperinvasive clones and affected regions. Recent shifts include global increases in serogroup W disease, meningococcal antimicrobial resistance (AMR), and meningococcal urethritis; additionally, unvaccinated populations have experienced disease resurgences following lifting of COVID-19 restrictions. Despite these changes, a close analysis of meningococcal epidemiology indicates consistent dominance of serogroups A, B, C, W, and Y and elevated IMD rates among infants and young children, adolescents/young adults, and older adults. Demonstrably effective vaccines against all 5 major disease-causing serogroups are available, and their prophylactic use represents a powerful weapon against IMD, including AMR. The World Health Organization's goal of defeating meningitis by the year 2030 demands broad protection against IMD, which in turn indicates an urgent need to expand meningococcal vaccination programs across major disease-causing serogroups and age-related risk groups.
Topics: Child; Infant; Adolescent; Young Adult; Humans; Child, Preschool; Aged; Neisseria meningitidis; Meningococcal Infections; Meningococcal Vaccines; Disease Outbreaks; Serogroup; Vaccines, Combined
PubMed: 38517733
DOI: 10.1080/14760584.2024.2329618 -
The Journal of Infection Dec 2020Serogroup B meningococci (MenB) remain a prominent cause of invasive meningococcal disease (IMD). The protein-based multicomponent 4CMenB and the bivalent MenB-FHbp are... (Review)
Review
Serogroup B meningococci (MenB) remain a prominent cause of invasive meningococcal disease (IMD). The protein-based multicomponent 4CMenB and the bivalent MenB-FHbp are the only currently available vaccines against MenB-caused IMD. Efficacy studies are not possible, due to the low incidence of IMD. Therefore, the vaccines' immunogenicity has been evaluated against several target strains chosen to quantify complement-mediated killing induced by each vaccine component in the serum bactericidal antibody assay. However, due to the wide genetic diversity and different expression levels of vaccine antigens across MenB strains, vaccine performance may differ from one strain to another. Here, we review the methods used to predict MenB strain coverage for 4CMenB and MenB-FHbp. Phenotypic assays such as the meningococcal antigen typing system (MATS, 4CMenB-specific) and the flow cytometric meningococcal antigen surface expression assay (MEASURE; MenB-FHbp-specific) were developed. Genomic approaches are also available, such as genetic MATS (gMATS) and the Bexsero antigen sequence type (BAST) scheme, both 4CMenB-specific. All methods allow tentative predictions of coverage across MenB strains, including that afforded by each vaccine antigen, and are rapid and reproducible. Real-world data on vaccine effectiveness are needed to confirm predictions obtained by these methods.
Topics: Antigens, Bacterial; Humans; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis, Serogroup B; Serogroup
PubMed: 32745637
DOI: 10.1016/j.jinf.2020.07.034 -
Expert Review of Vaccines Jun 2022Recombinant surface protein meningococcal serogroup B (MenB) vaccines are available but with different antigen compositions, leading to differences between vaccines in... (Review)
Review
INTRODUCTION
Recombinant surface protein meningococcal serogroup B (MenB) vaccines are available but with different antigen compositions, leading to differences between vaccines in their immunogenicity and likely breadth of coverage. The serology and breadth of coverage assessment for MenB vaccines are multifaceted areas, and a comprehensive understanding of these complexities is required to appropriately compare licensed vaccines and those under development.
AREAS COVERED
In the first of two companion papers that comprehensively review the serology and breadth of coverage assessment for MenB vaccines, the history of early meningococcal vaccines is considered in this narrative review to identify transferable lessons applicable to the currently licensed MenB vaccines and those under development, as well as their serology.
EXPERT OPINION
Understanding correlates of protection and the breadth of coverage assessment for meningococcal surface protein vaccines is significantly more complex than that for capsular polysaccharide vaccines. Determination and understanding of the breadth of coverage of surface protein vaccines are clinically important and unique to each vaccine formulation. It is essential to estimate the proportion of MenB cases that are preventable by a specific vaccine to assess its overall potential impact and to compare the benefits and limitations of different vaccines in preventing invasive meningococcal disease.
Topics: Antigens, Bacterial; Humans; Membrane Proteins; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis, Serogroup B
PubMed: 34287103
DOI: 10.1080/14760584.2021.1940144 -
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 -
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 -
Expert Review of Vaccines Oct 2021Species of the genus are important global pathogens. (gonococcus) causes the sexually transmitted disease gonorrhea and (meningococcus) causes meningitis and sepsis.... (Review)
Review
INTRODUCTION
Species of the genus are important global pathogens. (gonococcus) causes the sexually transmitted disease gonorrhea and (meningococcus) causes meningitis and sepsis. Liposomes are self-assembled spheres of phospholipid bilayers enclosing a central aqueous space, and they have attracted much interest and use as a delivery vehicle for vaccine antigens.
AREAS COVERED
A brief background on infections and the success of licensed meningococcal vaccines are provided. The absence of a gonococcal vaccine is highlighted. The use of liposomes for delivering antigens and adjuvants, for the purposes of generating specific immune responses, is reviewed. The use of other lipid-based systems for antigen and adjuvant delivery is examined briefly.
EXPERT OPINION
With renewed interest in developing a gonococcal vaccine, liposomes remain an attractive option for delivering antigens. The discipline of nanotechnology provides additional nanoparticle-based options for gonococcal vaccine development. Future work would be needed to tailor the composition of liposomes and other nanoparticles to the specific vaccine antigen(s), in order to generate optimal anti-gonococcal immune responses. The potential use of liposomes and other nanoparticles to deliver anti-gonococcal compounds to treat infections also should be explored further.
Topics: Gonorrhea; Humans; Liposomes; Meningococcal Vaccines; Neisseria; Neisseria gonorrhoeae; Neisseria meningitidis
PubMed: 34524062
DOI: 10.1080/14760584.2021.1981865 -
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 -
Vaccine Jul 2023The spleen is responsible for blood filtration and mounting an immune response against pathogens. In some people the spleen must be surgically removed because of...
The spleen is responsible for blood filtration and mounting an immune response against pathogens. In some people the spleen must be surgically removed because of traumatic events or oncological and hematological conditions. These patients are at higher risk of developing diseases caused by encapsulated bacteria throughout their lives. Thus, immunisations are advised for splenectomised persons to prevent infection caused by Streptococcus pneumoniae, Neisseria meningitidis and Haemophilus influenzae type b (Hib). This study assessed vaccination coverage (VC) among Norwegian patients with surgical asplenia. Using the Nomesco Classification of Surgical Procedures codes, patient information (age, sex, date of initial diagnosis and date of surgery) was acquired from the Norwegian Patient Registry. The National Immunization Register provided information on vaccination status and data of any subsequent invasive bacterial infections were obtained from the Norwegian Surveillance System for Communicable Diseases. From the total population of Norway, 3155 patients who had undergone complete splenectomy were identified. Of these, 914 (29.0%) had received at least one dose of pneumococcal conjugate vaccine (PCV), 1324 (42.0%) at least one dose of pneumococcal polysaccharide vaccine and 589 (18.7%) had received both. Only 4.2% of the patients had received two doses of a meningococcal ACWY conjugate vaccine, while 8.0% of 1467 patients splenectomised after 2014 had received at least two doses of a serogroup B meningococcal vaccine. The VC for Hib was 18.7%. Nearly all splenectomised children under the age of 10 were vaccinated with Hib and PCV as these vaccines are included in the childhood immunisation program. For all vaccines, VC decreased with age. Twenty-nine invasive bacterial infections were registered post-splenectomy in 25 patients. Vaccination according to national recommendations could have prevented at least 8 (28%) of these infections. Our study showed that efforts are required to increase VC of splenectomised individuals in Norway.
Topics: Child; Humans; Bacterial Infections; Haemophilus influenzae type b; Haemophilus Vaccines; Meningococcal Vaccines; Norway; Pneumococcal Vaccines; Splenectomy; Vaccination; Vaccines, Conjugate; Guideline Adherence; Vaccination Coverage
PubMed: 37336662
DOI: 10.1016/j.vaccine.2023.06.034