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The Journal of Infection Mar 2022This review article incorporates information from the 4th Global Meningococcal Initiative summit meeting. Since the introduction of stringent COVID-19 infection control... (Review)
Review
This review article incorporates information from the 4th Global Meningococcal Initiative summit meeting. Since the introduction of stringent COVID-19 infection control and lockdown measures globally in 2020, there has been an impact on IMD prevalence, surveillance, and vaccination compliance. Incidence rates and associated mortality fell across various regions during 2020. A reduction in vaccine uptake during 2020 remains a concern globally. In addition, several Neisseria meningitidis clonal complexes, particularly CC4821 and CC11, continue to exhibit resistance to antibiotics, with resistance to ciprofloxacin or beta-lactams mainly linked to modifications of gyrA or penA alleles, respectively. Beta-lactamase acquisition was also reported through horizontal gene transfer (bla) involving other bacterial species. Despite the challenges over the past year, progress has also been made on meningococcal vaccine development, with several pentavalent (serogroups ABCWY and ACWYX) vaccines currently being studied in late-stage clinical trial programmes.
Topics: COVID-19; Communicable Disease Control; Humans; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis; SARS-CoV-2; Serogroup
PubMed: 34838594
DOI: 10.1016/j.jinf.2021.11.016 -
Human Vaccines & Immunotherapeutics Jul 2017The protective effect of meningococcal vaccines targeting disease causing serogroups exemplified by the introduction of MenAfriVac™ in Africa, is well established and...
The protective effect of meningococcal vaccines targeting disease causing serogroups exemplified by the introduction of MenAfriVac™ in Africa, is well established and documented in large population-based studies. Due to the emergence of other meningococcal disease causing serogroups, novel vaccine formulations are needed. There is a high potential for novel nanotechnology-based meningococcal vaccine formulations that can provide wider vaccine coverage. The proposed meningococcal vaccine formulation contains spherical shaped micro and nanoparticles that are biological mimics of Niesseria meningitidis, therefore present to immune system as invader and elicit robust immune responses. Vaccine nanoparticles encapsulate meningococcal CPS polymers in a biodegradable material that slowly release antigens, therefore enhance antigen presentation by exerting antigen depot effect. The antigenicity of meningococcal vaccine delivered in nanoparticles is significantly higher when compared to vaccine delivered in solution. Preclinical studies are required to assess the immunogenicity of novel vaccine formulations. Therefore, implementing various in-vitro human immune cell-based assays that mimic in-vivo interactions, would provide good insight on optimal antigen dose, effective antigen presentation, facilitate screening of various vaccine and adjuvant combinations and predict in-vivo immunogenicity. This rapid approach is cost-effective and provides data required for the preclinical immunogenicity assessment of novel meningococcal vaccine formulations.
Topics: Drug Carriers; Drug Evaluation, Preclinical; Humans; Meningococcal Infections; Meningococcal Vaccines; Nanoparticles; Neisseria meningitidis
PubMed: 28394704
DOI: 10.1080/21645515.2017.1305528 -
The Journal of Infection Nov 2022Invasive meningococcal disease (IMD) is a life-threatening disease that can rapidly progress to death or leave survivors with severe, life-long sequelae. Five... (Review)
Review
OBJECTIVES
Invasive meningococcal disease (IMD) is a life-threatening disease that can rapidly progress to death or leave survivors with severe, life-long sequelae. Five meningococcal serogroups (A, B, C, W and Y) account for nearly all IMD. Meningococcal serogroup distribution fluctuates over time across the world and age groups. Here, we consider the potential public health impact of a pentavalent MenABCWY vaccine developed to help further control meningococcal disease and improve immunisation rates.
RESULTS
The GSK MenABCWY vaccine combines the antigenic components of MenACWY-CRM (Menveo®) and 4CMenB (Bexsero®), building on a wide body of clinical experience and real-world evidence. Both approved vaccines have acceptable safety profiles, demonstrate immunogenicity, and are broadly used, including in national immunisation programmes in several countries. Since the advent of quadrivalent vaccines, public health in relation to IMD has improved, with a decline in the overall incidence of IMD and an increase in vaccine coverage.
CONCLUSION
A pentavalent MenABCWY has the potential to provide further public health benefits through practical, broad IMD protection programmes encompassing serogroups A, B, C, W and Y, and is currently in late-stage development.
Topics: Humans; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis; Public Health; Vaccines, Combined; Vaccines, Conjugate
PubMed: 36087745
DOI: 10.1016/j.jinf.2022.09.001 -
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 -
Infection and Immunity Dec 2023The bacterial pathogen is an urgent global health problem due to increasing numbers of infections, coupled with rampant antibiotic resistance. Vaccines against...
The bacterial pathogen is an urgent global health problem due to increasing numbers of infections, coupled with rampant antibiotic resistance. Vaccines against gonorrhea are being prioritized to combat drug-resistant . Meningococcal serogroup B vaccines such as four-component meningococcal B vaccine (4CMenB) are predicted by epidemiology studies to cross-protect individuals from natural infection with and elicit antibodies that cross-react with . Evaluation of vaccine candidates for gonorrhea requires a suite of assays for predicting efficacy and in animal models of infection, including the role of antibodies elicited by immunization. Here, we present the development and optimization of assays to evaluate antibody functionality after immunization of mice: antibody binding to intact , serum bactericidal activity, and opsonophagocytic killing activity using primary human neutrophils [polymorphonuclear leukocytes (PMNs)]. These assays were developed with purified antibodies against and used to evaluate serum from mice that were vaccinated with 4CMenB or given alum as a negative control. Results from these assays will help prioritize gonorrhea vaccine candidates for advanced preclinical to early clinical studies and will contribute to identifying correlates and mechanisms of immune protection against .
Topics: Humans; Mice; Animals; Meningococcal Vaccines; Neisseria gonorrhoeae; Gonorrhea; Meningococcal Infections; Neisseria meningitidis; Bacterial Vaccines; Antibodies; Vaccines, Combined; Antibodies, Bacterial; Neisseria meningitidis, Serogroup B; Antigens, Bacterial
PubMed: 37991382
DOI: 10.1128/iai.00309-23 -
Human Vaccines & Immunotherapeutics May 2018This study aimed to evaluate the knowledge, attitudes and practice about invasive meningococcal disease and the relative vaccine for adolescent in Italy. A...
This study aimed to evaluate the knowledge, attitudes and practice about invasive meningococcal disease and the relative vaccine for adolescent in Italy. A cross-sectional study was conducted from March to May 2017 among a sample of 771 adolescents in the geographic area of Naples (Italy). A self-administered anonymous questionnaire was used to collect demographics, knowledge about meningitis and preventive measures, perceived risk for contracting meningitis, attitude towards the utility of meningococcal vaccine, and adolescents' willingness to receive a meningococcal vaccine. 85.2% of participants have heard about meningitis, 57.2% knew that adolescents are a susceptible population but only 30.3% knew that meningitis is transmitted by respiratory droplets. Moreover, 40.5% of adolescents knew that meningitis is a vaccine-preventable disease and that adolescents could be vaccinated. This knowledge was significantly greater among female participants, among those who talk with parents about vaccinations, among who have received information about vaccinations from physicians, among who have positive attitude towards the utility of information received on vaccinations and among who don't feel the need of additional information about meningitis. As regard the attitudes, 25.7% of adolescents thought that the vaccine was very useful. Males, adolescent aged 11-13 years, those who had the positive attitude towards the utility of information received about vaccinations and those who had received at least one vaccination in the last year were more likely to have this attitude. The our finding identifies the need to improve adolescents' knowledge about meningitis and its related vaccinations, through correct health education, in order to have a good acceptance of vaccination.
Topics: Adolescent; Adolescent Behavior; Adult; Age Factors; Child; Cross-Sectional Studies; Female; Health Knowledge, Attitudes, Practice; Humans; Italy; Male; Meningococcal Infections; Meningococcal Vaccines; Patient Acceptance of Health Care; Patient Education as Topic; Sex Factors; Surveys and Questionnaires; Vaccination; Young Adult
PubMed: 29452028
DOI: 10.1080/21645515.2018.1436918 -
Clinical Infectious Diseases : An... Nov 2015A new group A meningococcal conjugate vaccine was developed to eliminate deadly meningitis epidemics in sub-Saharan Africa. (Review)
Review
BACKGROUND
A new group A meningococcal conjugate vaccine was developed to eliminate deadly meningitis epidemics in sub-Saharan Africa.
METHODS
From the outset of the project, advocacy and communication strategies were developed and adjusted as the project evolved in Europe, Africa, India, and the United States. Communications efforts were evidence-based, and involved partnerships with the media and various stakeholders including African ministries of health, the World Health Organization, UNICEF, Gavi, the Centers for Disease Control and Prevention, and Médecins Sans Frontières.
RESULTS
The implementation of an integrated communication strategy ensured the active cooperation of stakeholders while providing an organized and defined format for the dissemination of project-related developmental activities and the successful introduction of the vaccine.
CONCLUSIONS
Early in the project, a communications strategy that engaged stakeholders and potential supporters was developed. The strategy was implemented and adapted as the project matured. Linked communication proved to be key to the successful wide-scale introduction of the PsA-TT (MenAfriVac) vaccine in Africa.
Topics: Africa South of the Sahara; Disease Transmission, Infectious; Europe; Humans; Immunization Programs; India; Interdisciplinary Communication; International Cooperation; Meningitis, Meningococcal; Meningococcal Vaccines; United States; World Health Organization
PubMed: 26553674
DOI: 10.1093/cid/civ493 -
International Journal of Environmental... Mar 2022Meningococcal disease is caused by ; 13 serogroups have been identified and differentiated from each other through their capsular polysaccharide. Serotypes A, B, C, W,...
Meningococcal disease is caused by ; 13 serogroups have been identified and differentiated from each other through their capsular polysaccharide. Serotypes A, B, C, W, X, and Y are responsible for nearly all infections worldwide. The most common clinical manifestations are meningitis and invasive meningococcal disease, both characterized by high mortality and long-term sequelae. The infection rate is higher in children younger than 1 year and in adolescents, who are frequently asymptomatic carriers. Vaccination is the most effective method of preventing infection and transmission. Currently, both monovalent meningococcal vaccines (against A, B, and C serotypes) and quadrivalent meningococcal vaccines (against serogroups ACYW) are available and recommended according to local epidemiology. The purpose of this article is to describe the meningococcal vaccines and to identify instruments that are useful for reducing transmission and implementing the vaccination coverage. This aim could be reached by switching from the monovalent to the quadrivalent vaccine in the first year of life, increasing vaccine promotion against ACYW serotypes among adolescents, and extending the free offer of the anti-meningococcal B vaccine to teens, co-administering it with others proposed in the same age group. Greater awareness of the severity of the disease and increased health education through web and social networks could represent the best strategies for promoting adhesion and active participation in the vaccination campaign. Finally, the development of a licensed universal meningococcal vaccine should be another important objective.
Topics: Adolescent; Child; Humans; Immunization Programs; Meningitis, Meningococcal; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis; Vaccination; Vaccines, Conjugate
PubMed: 35409716
DOI: 10.3390/ijerph19074035 -
Medicina (Kaunas, Lithuania) Dec 2018Vaccination against bacterial pathogens is decisive for preventing invasive meningococcal disease and pediatricians play a pivotal role in vaccination compliance and...
Vaccination against bacterial pathogens is decisive for preventing invasive meningococcal disease and pediatricians play a pivotal role in vaccination compliance and coverage. The aim of this study was to investigate awareness, attitude, and practices toward the vaccine against Meningococcal B serogroup (4CMenB) among a sample of Italian pediatricians. A cross-sectional study was carried out using an online questionnaire from March to May 2015. Three multivariate logistic regression models were built to identify factors associated with the outcomes of interest. : The data showed that 95.5% of the interviewees correctly responded about the availability of 4CMenB vaccine in Italy, while only 28.0% knew the vaccination schedule for children aged two years or under. This knowledge was significantly higher in younger pediatricians and in those who worked a higher number of hours per week. Pediatricians self-reported a positive attitude toward the utility and safety of 4CMenB vaccine. Those pediatricians with a strong positive attitude toward the utility of the vaccine, who knew the vaccination schedules for children of two years or under, and who declared a satisfactory or good knowledge about the vaccine were more likely to inform parents about its availability in Italy, recommend the vaccination, and verify patients' vaccination status, in their daily practice. : The study highlights factors that currently influence pediatricians' practices regarding the 4CMenB vaccine. The results showed the possible actions recommended to improve physicians' awareness and behaviors in order to improve the vaccination compliance and invasive meningococcal diseases prevention.
Topics: Adult; Aged; Cross-Sectional Studies; Education, Medical, Continuing; Female; Health Knowledge, Attitudes, Practice; Humans; Immunization Programs; Italy; Logistic Models; Male; Meningitis, Meningococcal; Meningococcal Vaccines; Middle Aged; Parents; Pediatricians; Surveys and Questionnaires
PubMed: 30513993
DOI: 10.3390/medicina54060100 -
The New England Journal of Medicine Dec 2017MenB-FHbp is a licensed meningococcal B vaccine targeting factor H-binding protein. Two phase 3 studies assessed the safety of the vaccine and its immunogenicity against... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
MenB-FHbp is a licensed meningococcal B vaccine targeting factor H-binding protein. Two phase 3 studies assessed the safety of the vaccine and its immunogenicity against diverse strains of group B meningococcus.
METHODS
We randomly assigned 3596 adolescents (10 to 18 years of age) to receive MenB-FHbp or hepatitis A virus vaccine and saline and assigned 3304 young adults (18 to 25 years of age) to receive MenB-FHbp or saline at baseline, 2 months, and 6 months. Immunogenicity was assessed in serum bactericidal assays that included human complement (hSBAs). We used 14 meningococcal B test strains that expressed vaccine-heterologous factor H-binding proteins representative of meningococcal B epidemiologic diversity; an hSBA titer of at least 1:4 is the accepted correlate of protection. The five primary end points were the proportion of participants who had an increase in their hSBA titer for each of 4 primary strains by a factor of 4 or more and the proportion of those who had an hSBA titer at least as high as the lower limit of quantitation (1:8 or 1:16) for all 4 strains combined after dose 3. We also assessed the hSBA responses to the primary strains after dose 2; hSBA responses to the 10 additional strains after doses 2 and 3 were assessed in a subgroup of participants only. Safety was assessed in participants who received at least one dose.
RESULTS
In the modified intention-to-treat population, the percentage of adolescents who had an increase in the hSBA titer by a factor of 4 or more against each primary strain ranged from 56.0 to 85.3% after dose 2 and from 78.8 to 90.2% after dose 3; the percentages of young adults ranged from 54.6 to 85.6% and 78.9 to 89.7%, after doses 2 and 3, respectively. Composite responses after doses 2 and 3 in adolescents were 53.7% and 82.7%, respectively, and those in young adults were 63.3% and 84.5%, respectively. Responses to the 4 primary strains were predictive of responses to the 10 additional strains. Most of those who received MenB-FHbp reported mild or moderate pain at the vaccination site.
CONCLUSIONS
MenB-FHbp elicited bactericidal responses against diverse meningococcal B strains after doses 2 and 3 and was associated with more reactions at the injection site than the hepatitis A virus vaccine and saline. (Funded by Pfizer; ClinicalTrials.gov numbers, NCT01830855 and NCT01352845 ).
Topics: Adolescent; Adult; Antibodies, Bacterial; Antigens, Bacterial; Bacterial Proteins; Child; Female; Fever; Humans; Intention to Treat Analysis; Male; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis, Serogroup B; Phylogeny; Single-Blind Method; Young Adult
PubMed: 29236639
DOI: 10.1056/NEJMoa1614474