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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 Apr 2020Invasive meningococcal disease (IMD) caused by the bacteria is rare but potentially fatal. For healthy adolescents, the US Advisory Committee on Immunization Practices...
Invasive meningococcal disease (IMD) caused by the bacteria is rare but potentially fatal. For healthy adolescents, the US Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination with MenACWY and recommends MenB vaccination under shared clinical decision-making (previously "Category B"). The recommendation for MenB vaccination was the first category B recommendation in adolescents, and it is unclear how healthcare providers (HCPs) implement these guidelines. This 2017 web-based survey of US HCPs explored characteristics associated with prescribing or receiving MenB and MenACWY vaccines, HCP knowledge of vaccine recommendations, and real-world practice patterns. Of 529 respondents, 436 prescribed MenB vaccines to their eligible adolescent/young adult patients and 93 prescribed MenACWY vaccines only. MenB vaccine prescribers were more likely to be pediatricians compared with MenACWY vaccine only prescribers, and patients who received MenB vaccines were more likely to be non-Hispanic whites living in shared spaces (eg, college dormitories) than those not receiving the vaccine. Seventy-seven percent of HCPs indicated that they prescribe MenACWY vaccines consistently with ACIP recommendations (to all members of an age group), whereas only 7% indicated that they prescribe MenB vaccines consistently with ACIP recommendations (individual clinical decision making). Patient-related factors, disease-related factors, and guidelines all influenced HCP decisions to prescribe meningococcal vaccines. Providing HCPs with clear guidance on how to initiate discussion of MenB vaccines with patients and their caregivers may aid in fully protecting US adolescents against meningococcal disease caused by 5 of the disease-causing serogroups.
Topics: Adolescent; Humans; Immunization; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis, Serogroup B; Pediatricians; Vaccination; Young Adult
PubMed: 31634035
DOI: 10.1080/21645515.2019.1682845 -
Expert Review of Vaccines Apr 2021Vaccination is an effective strategy to combat invasive meningococcal disease (IMD). Vaccines against the major disease-causing meningococcal serogroups are available;... (Review)
Review
INTRODUCTION
Vaccination is an effective strategy to combat invasive meningococcal disease (IMD). Vaccines against the major disease-causing meningococcal serogroups are available; however, development of vaccines against serogroup B faced particular challenges, including the inability to target traditional meningococcal antigens (i.e. polysaccharide capsule) and limited alternative antigens due to serogroup B strain diversity. Two different recombinant, protein-based, serogroup B (MenB) vaccines that may address these challenges are currently available. These vaccines have been extensively evaluated in pre-licensure safety and immunogenicity trials, and recently in real-world studies on effectiveness, safety, and impact on disease burden.
AREAS COVERED
This review provides healthcare professionals, particularly pediatricians, an overview of currently available MenB vaccines, including development strategies and evaluation of coverage.
EXPERT OPINION
Overall, recombinant MenB vaccines are valuable tools for healthcare professionals to protect patients against IMD. Their development required innovative design approaches that overcame challenging hurdles and identified novel protein antigen targets; however, important distinctions in the approaches used in their development, evaluation, and administration exist and many unanswered questions remain. Healthcare providers frequently prescribing MenB vaccines are challenged to keep abreast of these differences to ensure patient protection against this serious disease.
Topics: Antigens, Bacterial; Delivery of Health Care; Health Personnel; Humans; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis, Serogroup B; Serogroup; Vaccines, Synthetic
PubMed: 34151699
DOI: 10.1080/14760584.2021.1899820 -
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 -
Journal of Pharmacy Practice Apr 2020Vaccine therapeutics and the practice of immunization provision are ever-changing. As pharmacy-based immunization services continue to flourish in the United States,... (Review)
Review
Vaccine therapeutics and the practice of immunization provision are ever-changing. As pharmacy-based immunization services continue to flourish in the United States, more and more patients are requesting both routine and travel vaccines in community pharmacies. However, vaccine recommendations from the Centers for Disease Control and Prevention/Advisory Committee on Immunization Practices (CDC/ACIP) can sometimes differ from product-specific US Food and Drug Administration (FDA)-indicated uses. In addition, changes in vaccine schedules, product availability, and disease outbreaks can present immunizing pharmacists with scenarios requiring a high level of clinical judgment. Thus, it is of paramount importance that all immunizing pharmacists maintain competency in the most recent evidence in vaccine therapeutics, as well as practice standards for vaccine provision and administration. This review provides an update of the most recent literature surrounding emerging topics in adolescent and adult immunizations-highlighting influential studies and recent developments in the prevention of herpes zoster, human papillomavirus (HPV), measles, mumps, rubella (MMR), meningococcal disease, tetanus, diphtheria, and pertussis. Key concepts discussed include the emergence of the new recombinant zoster vaccine (RZV), meningococcal vaccine product selection, MMR revaccination during disease outbreaks, tetanus vaccine product selection, and duration of pertussis immunity with vaccination.
Topics: Adolescent; Adult; Education, Pharmacy; Herpes Zoster Vaccine; Humans; Immunization; Immunization Schedule; Measles-Mumps-Rubella Vaccine; Meningococcal Vaccines; Papillomavirus Vaccines; Pharmacists; Tetanus Toxoid; United States; Vaccination
PubMed: 30352534
DOI: 10.1177/0897190018802937 -
Postgraduate Medicine Mar 2020Invasive meningococcal disease (IMD) is a potentially devastating infection associated with high mortality and long-term sequelae; however, vaccines are available to... (Review)
Review
Invasive meningococcal disease (IMD) is a potentially devastating infection associated with high mortality and long-term sequelae; however, vaccines are available to protect against the five common disease-causing serogroups (A, B, C, W, and Y). Because traditional field efficacy clinical trials were not feasible due to low IMD incidence that necessitates a very large number of participants, serum bactericidal antibody (SBA) assays using rabbit (rSBA) or human (hSBA) complement were established as surrogates of meningococcal vaccine efficacy and are now routinely used to support vaccine licensure. Specifically, rSBA assays have been used to evaluate responses to meningococcal capsular polysaccharide-protein conjugate vaccines against serogroups A, C, W, and Y; the accepted correlate of protection for rSBA assays is a titer ≥1:8. Importantly, because the bacterial capsular polysaccharide antigen is conserved across strains, only one test strain that expresses an invariant polysaccharide capsule for each serogroup is required to assess coverage. rSBA assays are unsuitable for subcapsular protein-based serogroup B (MenB) vaccines, and therefore, hSBA assays have been used for licensure; titers ≥1:4 are considered the correlate of protection against IMD for hSBA. In contrast to MenACWY vaccines, because bacterial surface proteins are antigenically variable, MenB vaccines must be tested with hSBA assays using multiple test strains that represent the antigenic diversity of disease-causing isolates. As this complexity regarding SBA assessment methods can make data interpretation difficult, herein we describe the use of hSBA assays to evaluate MenB vaccine efficacy and to support licensure. In addition, we highlight how the two recently approved MenB vaccines differ in their use of hSBA assays in clinical studies to demonstrate broad protection against MenB IMD.
Topics: Animals; Antibodies, Bacterial; Antigens, Bacterial; Complement System Proteins; Humans; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis, Serogroup B; Rabbits
PubMed: 32124678
DOI: 10.1080/00325481.2019.1696582 -
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 -
Vaccine Jul 2023Carriage of Neisseria meningitidisis an accepted endpoint in monitoring meningococcal vaccine effects. We applied molecular methods to assess the impact of menACWY...
Surveillance of Neisseria meningitidis carriage four years after menACWY vaccine implementation in the Netherlands reveals decline in vaccine-type and rise in genogroup e circulation.
Carriage of Neisseria meningitidisis an accepted endpoint in monitoring meningococcal vaccine effects. We applied molecular methods to assess the impact of menACWY vaccine implementation on meningococcal carriage and genogroup-specific prevalence in young adults in Fall of 2022, four years after the introduction of the tetravalent vaccine in the Netherlands. The overall carriage rate of genogroupable meningococci was not significantly different compared to a pre-menACWY cohort investigated in 2018 (20.8 % or 125 of 601 versus 17.4 % or 52 of 299 individuals, p = 0.25). Of 125 carriers of genogroupable meningococci, 122 (97.6 %) were positive for either vaccine-types menC, menW, menY or genogroups, menB, menE, and menX, which are not targeted by the menACWY vaccine. Compared with a pre-vaccine-implementation cohort, there was 3.8-fold reduction (p < 0.001) in vaccine-type carriage rates and 9.0-fold increase (p < 0.0001) in non-vaccine type menE prevalence. We observe a reduction in menW and menY and an increase in menE, which suggest that implementation of menACWY vaccine affected carriage.
Topics: Young Adult; Humans; Neisseria meningitidis; Meningococcal Vaccines; Netherlands; Meningococcal Infections; Genotype; Vaccines, Combined
PubMed: 37423800
DOI: 10.1016/j.vaccine.2023.06.078 -
Human Vaccines & Immunotherapeutics Nov 2022Vaccination offers the best way to prevent invasive meningococcal disease (IMD). As demonstrated in countries with national immunization programs (NIPs) against IMD,...
Immunogenicity and safety of MenACWY-TT, a quadrivalent meningococcal tetanus toxoid conjugate vaccine recently licensed in the United States for individuals ≥2 years of age.
Vaccination offers the best way to prevent invasive meningococcal disease (IMD). As demonstrated in countries with national immunization programs (NIPs) against IMD, meningococcal conjugate vaccines have contributed to significant declines in incidence. Since some meningococcal vaccines are associated with modest immunogenicity in infants, possible immunological interference upon concomitant administration with some pediatric vaccines, and administration errors resulting from improper reconstitution, opportunities for improvement exist. A quadrivalent conjugate vaccine, MenQuadfi® (Meningococcal [Serogroups A, C, Y, and W] Conjugate Vaccine; Sanofi, Swiftwater, Pennsylvania), was approved in 2020 for the prevention of IMD caused by meningococcal serogroups A, C, W, and Y in individuals ≥2 years of age in the United States. Five pivotal studies and one ancillary study supported approval in the United States; clinical trials in infants are ongoing. Data on the immunogenicity and safety of this vaccine are presented, and its potential value in clinical practice is discussed.
Topics: Infant; Humans; Child; United States; Meningococcal Vaccines; Vaccines, Conjugate; Tetanus Toxoid; Meningococcal Infections; Neisseria meningitidis; Vaccines, Combined; Antibodies, Bacterial; Immunogenicity, Vaccine
PubMed: 35947774
DOI: 10.1080/21645515.2022.2099142 -
The Lancet. Infectious Diseases Apr 2020
Topics: Adolescent; Australia; Disease Outbreaks; Gonorrhea; Humans; Meningococcal Infections; Meningococcal Vaccines; Neisseria gonorrhoeae; Neisseria meningitidis, Serogroup B; Vaccination; Vaccines, Conjugate
PubMed: 32222210
DOI: 10.1016/S1473-3099(20)30184-5