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MMWR. Morbidity and Mortality Weekly... Jul 2017Use of eculizumab (Soliris, Alexion Pharmaceuticals), a terminal complement inhibitor, is associated with a 1,000-fold to 2,000-fold increased incidence of meningococcal...
Use of eculizumab (Soliris, Alexion Pharmaceuticals), a terminal complement inhibitor, is associated with a 1,000-fold to 2,000-fold increased incidence of meningococcal disease (1). Administration of meningococcal vaccines is recommended for patients receiving eculizumab before beginning treatment (2,3). Sixteen cases of meningococcal disease were identified in eculizumab recipients in the United States during 2008-2016; among these, 11 were caused by nongroupable Neisseria meningitidis. Fourteen patients had documentation of receipt of at least 1 dose of meningococcal vaccine before disease onset. Because eculizumab recipients remain at risk for meningococcal disease even after receipt of meningococcal vaccines, some health care providers in the United States as well as public health agencies in other countries recommend antimicrobial prophylaxis for the duration of eculizumab treatment; a lifelong course of treatment is expected for many patients. Heightened awareness, early care seeking, and rapid treatment of any symptoms consistent with meningococcal disease are essential for all patients receiving eculizumab treatment, regardless of meningococcal vaccination or antimicrobial prophylaxis status.
Topics: Antibodies, Monoclonal, Humanized; Humans; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis; Risk Assessment; Serogroup; United States
PubMed: 28704351
DOI: 10.15585/mmwr.mm6627e1 -
The New England Journal of Medicine May 2023An effective, affordable, multivalent meningococcal conjugate vaccine is needed to prevent epidemic meningitis in the African meningitis belt. Data on the safety and... (Comparative Study)
Comparative Study Randomized Controlled Trial
BACKGROUND
An effective, affordable, multivalent meningococcal conjugate vaccine is needed to prevent epidemic meningitis in the African meningitis belt. Data on the safety and immunogenicity of NmCV-5, a pentavalent vaccine targeting the A, C, W, Y, and X serogroups, have been limited.
METHODS
We conducted a phase 3, noninferiority trial involving healthy 2-to-29-year-olds in Mali and Gambia. Participants were randomly assigned in a 2:1 ratio to receive a single intramuscular dose of NmCV-5 or the quadrivalent vaccine MenACWY-D. Immunogenicity was assessed at day 28. The noninferiority of NmCV-5 to MenACWY-D was assessed on the basis of the difference in the percentage of participants with a seroresponse (defined as prespecified changes in titer; margin, lower limit of the 96% confidence interval [CI] above -10 percentage points) or geometric mean titer (GMT) ratios (margin, lower limit of the 98.98% CI >0.5). Serogroup X responses in the NmCV-5 group were compared with the lowest response among the MenACWY-D serogroups. Safety was also assessed.
RESULTS
A total of 1800 participants received NmCV-5 or MenACWY-D. In the NmCV-5 group, the percentage of participants with a seroresponse ranged from 70.5% (95% CI, 67.8 to 73.2) for serogroup A to 98.5% (95% CI, 97.6 to 99.2) for serogroup W; the percentage with a serogroup X response was 97.2% (95% CI, 96.0 to 98.1). The overall difference between the two vaccines in seroresponse for the four shared serogroups ranged from 1.2 percentage points (96% CI, -0.3 to 3.1) for serogroup W to 20.5 percentage points (96% CI, 15.4 to 25.6) for serogroup A. The overall GMT ratios for the four shared serogroups ranged from 1.7 (98.98% CI, 1.5 to 1.9) for serogroup A to 2.8 (98.98% CI, 2.3 to 3.5) for serogroup C. The serogroup X component of the NmCV-5 vaccine generated seroresponses and GMTs that met the prespecified noninferiority criteria. The incidence of systemic adverse events was similar in the two groups (11.1% in the NmCV-5 group and 9.2% in the MenACWY-D group).
CONCLUSIONS
For all four serotypes in common with the MenACWY-D vaccine, the NmCV-5 vaccine elicited immune responses that were noninferior to those elicited by the MenACWY-D vaccine. NmCV-5 also elicited immune responses to serogroup X. No safety concerns were evident. (Funded by the U.K. Foreign, Commonwealth, and Development Office and others; ClinicalTrials.gov number, NCT03964012.).
Topics: Humans; Gambia; Health Status; Mali; Vaccines, Conjugate; Meningococcal Vaccines; Child, Preschool; Child; Adolescent; Young Adult; Adult; Immunogenicity, Vaccine; Injections, Intramuscular; Meningitis; Epidemics
PubMed: 37224196
DOI: 10.1056/NEJMoa2214924 -
Pathogens and Global Health Oct 2014Neisseria meningitidis causes globally 1·2 million invasive disease cases and 135,000 deaths per year, mostly in infants and adolescents. A century of traditional... (Review)
Review
Neisseria meningitidis causes globally 1·2 million invasive disease cases and 135,000 deaths per year, mostly in infants and adolescents. A century of traditional vaccinology had failed the fight against the serogroup B meningococcus (MenB), mostly prevalent in developed countries. Eighteen years after the publication of the first complete genome sequence from a living organism, thanks to an innovative genome-based approach named 'reverse vaccinology', the first broadly effective MenB vaccine was licensed for use by the European Medical Agency and other authorities, and is being implemented worldwide. Here we review this long and passionate journey, from the disease epidemiology to novel antigen discovery, from vaccine clinical development to public health impact: two decades of scientific and technological innovation to defeat one of the most sudden and devastating invasive diseases.
Topics: Drug Approval; History, 21st Century; Humans; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis
PubMed: 25417906
DOI: 10.1179/2047773214Y.0000000162 -
The New England Journal of Medicine Aug 2023
Topics: Humans; Meningococcal Vaccines; Gambia; Mali; Vaccines, Conjugate
PubMed: 37590458
DOI: 10.1056/NEJMc2307375 -
Human Vaccines & Immunotherapeutics Nov 2022This review considers the pathogenesis, diagnosis, and epidemiology of invasive meningococcal disease in infants, to examine and critique meningococcal disease... (Review)
Review
This review considers the pathogenesis, diagnosis, and epidemiology of invasive meningococcal disease in infants, to examine and critique meningococcal disease prevention in this population through vaccination. High rates of meningococcal disease and poor outcomes, particularly for very young infants, highlight the importance of meningococcal vaccination in early infancy. Although effective and safe meningococcal vaccines are available for use from 6 weeks of age, they are not recommended globally. Emerging real-world data from the increased incorporation of these vaccines within immunization programs inform recommendations regarding effectiveness, appropriate vaccination schedule, possible long-term safety effects, and persistence of antibody responses. Importantly, to protect infants from IMD, national vaccination recommendations should be consistent with available data regarding vaccine safety, effectiveness, and disease risk.
Topics: Humans; Immunization Schedule; Infant; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis; Vaccination
PubMed: 35482946
DOI: 10.1080/21645515.2021.1979846 -
Vaccine Apr 2021The first safe and effective vaccine for the prevention of invasive meningococcal disease was created fifty years ago. The vaccine employed a novel platform,...
The first safe and effective vaccine for the prevention of invasive meningococcal disease was created fifty years ago. The vaccine employed a novel platform, polysaccharide capsular antigen, based on the discovery that anticapsular antibody conferred protective immunity in humans. As with most new paradigms in vaccinology, it derived from important basic research from other scientific disciplines over the preceding years. The success of the first monovalent polysaccharide vaccine in nearly eliminating invasive meningococcal disease in military settings led to accelerated advances in polysaccharide vaccine development against other serogroups of meningococcus and other encapsulated pathogens. As gaps in vaccine efficacy arose over the past half-century, new vaccine technologies and approaches were developed to address the challenges. Several of these, including conjugate vaccines and "reverse vaccinology" led to other novel, successful vaccines that have had a significant, favorable global impact on invasive meningococcal disease. The history of meningococcal vaccine discovery may provide insights into the future of vaccine efforts against other infectious threats.
Topics: Humans; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis; Vaccines, Conjugate
PubMed: 33752953
DOI: 10.1016/j.vaccine.2021.03.024 -
Human Vaccines & Immunotherapeutics Aug 2023The four-component meningococcal serogroup B vaccine (4CMenB) is indicated for the prevention of invasive meningococcal disease (IMD) caused by serogroup B.... (Review)
Review
The four-component meningococcal serogroup B vaccine (4CMenB) is indicated for the prevention of invasive meningococcal disease (IMD) caused by serogroup B. Co-administering 4CMenB with other vaccines may improve vaccine uptake provided that the safety and immunogenicity of either are not affected. Published literature on the immunogenicity and reactogenicity of 4CMenB co-administered with other routine childhood and adulthood vaccines was reviewed. From 282 publications identified, data were collated from 10 clinical studies, 3 real-world studies, and 3 reviews. The evidence showed that 4CMenB co-administration is not associated with significant safety concerns or clinically relevant immunological interferences. The increased reactogenicity (e.g., fever) associated with 4CMenB co-administration can be adequately managed with prophylactic paracetamol in children. Thus, 4CMenB co-administration has the potential to maximize vaccine coverage and improve protection against IMD globally.
Topics: Child; Humans; Meningococcal Vaccines; Meningococcal Infections; Serogroup; Acetaminophen; Fever; Neisseria meningitidis, Serogroup B
PubMed: 37642229
DOI: 10.1080/21645515.2023.2245705 -
Human Vaccines & Immunotherapeutics May 2018Invasive meningococcal disease causes meningitis and septicemia worldwide with highest rates of disease occurring in children <2 years of age, and in particular young... (Review)
Review
Invasive meningococcal disease causes meningitis and septicemia worldwide with highest rates of disease occurring in children <2 years of age, and in particular young infants. Vaccination during pregnancy has been a successful strategy for prevention of other infections in young infants, most notably tetanus, pertussis and influenza. However, few studies of meningococcal vaccines in pregnancy have been undertaken, and none include the most commonly used current vaccines to prevent disease by capsular groups A, B, C, W and Y. The limited data suggest that the older polysaccharide vaccines are immunogenic, but the impact on prevention of infant disease has not been measured. Further studies of MenB protein vaccines and MenA protein-polysaccharide conjugate vaccines in particular are needed if vaccination in pregnancy is to be utilized as an approach to prevention of meningococcal disease in young infants.
Topics: Female; Humans; Immunity, Maternally-Acquired; Immunogenicity, Vaccine; Incidence; Infant; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis; Pregnancy; Serogroup; Vaccination; Vaccines, Conjugate
PubMed: 29485347
DOI: 10.1080/21645515.2018.1445447 -
Expert Review of Vaccines Apr 2015Meningococcal disease is a major public health problem and immunization is considered the best strategy for prevention. The introduction of meningococcal C conjugate... (Review)
Review
Meningococcal disease is a major public health problem and immunization is considered the best strategy for prevention. The introduction of meningococcal C conjugate immunization schedules that targeted adolescents, with catch-up programs in several European countries, Australia and Canada proved to be highly effective, with dramatic reduction in the incidence of serogroup C disease, not only in vaccinated, but also in unvaccinated individuals. Meningococcal quadrivalent (A, C, W, Y) conjugate vaccines are now licensed and are being used in adolescent programs in North America and to control serogroup W disease in South America. In the African meningitis belt, a mass immunization campaign against serogroup A disease using a meningococcal A conjugate vaccine is now controlling the devastating epidemics of meningococcal disease. After introducing new immunization programs, it is of importance to maintain enhanced surveillance for a better understanding of the changing nature of disease epidemiology. This information is crucial for identifying optimal immunization policies.
Topics: Global Health; Humans; Immunization Programs; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis; Vaccination
PubMed: 25494168
DOI: 10.1586/14760584.2015.979799 -
Pediatrics Nov 2023The Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts that provides advice to the Centers for Disease Control and...
The Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts that provides advice to the Centers for Disease Control and Prevention, normally meets 3 times per year to develop US vaccine recommendations. The ACIP met June 21-23, 2023, to discuss respiratory syncytial virus (RSV) vaccines, influenza vaccines, pneumococcal vaccines, meningococcal vaccines, and COVID-19 vaccines. The ACIP also held a special meeting on August 3, 2023, to discuss RSV prophylaxis in infants. This update summarizes the proceedings of these meetings that are most relevant to the pediatric population. Major updates for pediatric clinicians include a new recommendation for the monoclonal antibody nirsevimab for prevention of RSV disease in all infants, recommendations regarding use of 20-valent pneumococcal conjugate vaccine, and discussion of potential forthcoming changes to meningococcal and COVID-19 vaccination recommendations.
Topics: Infant; United States; Child; Humans; COVID-19 Vaccines; Advisory Committees; Respiratory Syncytial Viruses; Immunization; Vaccination; Influenza Vaccines; Meningococcal Vaccines; Immunization Schedule
PubMed: 37641189
DOI: 10.1542/peds.2023-063955