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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 -
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 -
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 -
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 -
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 -
Serogroup A meningococcal conjugate vaccines: building sustainable and equitable vaccine strategies.Expert Review of Vaccines May 2020For well over 100 years, meningococcal disease due to serogroup A (MenA) has caused severe epidemics globally, especially in the meningitis belt of sub-Saharan Africa. (Review)
Review
INTRODUCTION
For well over 100 years, meningococcal disease due to serogroup A (MenA) has caused severe epidemics globally, especially in the meningitis belt of sub-Saharan Africa.
AREAS COVERED
The article reviews the background and identification of MenA, the global and molecular epidemiology of MenA, and the outbreaks of MenA in the African meningitis belt. The implementation (2010) of an equitable MenA polysaccharide-protein conjugate vaccine (Ps-TT, MenAfriVac) and the strategy to control MenA in sub-Saharan Africa is described. The development of a novel multi-serogroup meningococcal conjugate vaccine (NmCV-5) that includes serogroup A is highlighted. The PubMed database (1996-2019) was searched for studies relating to MenA outbreaks, vaccine, and immunization strategies; and the Neisseria PubMLST database of 1755 MenA isolates (1915-2019) was reviewed.
EXPERT OPINION
Using strategies from the successful MenAfriVac campaign, expanded collaborative partnerships were built to develop a novel, low-cost multivalent component meningococcal vaccine that includes MenA. This vaccine promises greater sustainability and is directed toward global control of meningococcal disease in the African meningitidis belt and beyond. The new WHO global roadmap addresses the continuing problem of bacterial meningitis, including meningococcal vaccine prevention, and provides a framework for further reducing the devastation of MenA.
Topics: Africa South of the Sahara; Disease Outbreaks; Global Health; Humans; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis, Serogroup A; Vaccination
PubMed: 32321332
DOI: 10.1080/14760584.2020.1760097 -
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 -
Human Vaccines & Immunotherapeutics Jun 2013Meningococcal disease remains a devastating and feared infection with a significant morbidity and mortality profile. The successful impact of meningococcal capsular... (Review)
Review
Meningococcal disease remains a devastating and feared infection with a significant morbidity and mortality profile. The successful impact of meningococcal capsular group C glyconconjugate vaccines introduced into the UK infant immunization schedule in 1999, has resulted in >80% of disease now being attributable to meningococcal capsular group B (MenB). MenB glyconconjugate vaccines are not immunogenic and hence, vaccine design has focused on sub-capsular antigens. Recently, a four component vaccine to combat MenB disease (4CMenB) has progressed through clinical development and was approved by the European Medicines Agency at the end of 2012. This vaccine has proven safe and immunogenic and has been predicted to provide protection against ~73% of the MenB disease from England and Wales. Recommendation/implementation of the vaccine into the UK infant schedule is currently being evaluated. 4CMenB has the potential to provide protection against a significant proportion of MenB disease in the UK which is currently unpreventable.
Topics: Clinical Trials as Topic; Drug Approval; Humans; Immunization Schedule; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis, Serogroup B; United Kingdom; Vaccines, Conjugate
PubMed: 23732894
DOI: 10.4161/hv.24689 -
Human Vaccines & Immunotherapeutics Dec 2012Meningococcal meningitis is caused by Neisseria meningitidis, a gram-negative, aerobic, encapsulated diplococcus. Meningococci are divided into numerous serogroups based... (Review)
Review
Meningococcal meningitis is caused by Neisseria meningitidis, a gram-negative, aerobic, encapsulated diplococcus. Meningococci are divided into numerous serogroups based on the composition of their capsular polysaccharide (Ps) antigens. At least 13 serogroups have been described: A, B, C, D, 29E, H, I, K, L, W-135, X, Y and Z. Out of these 13, six (A, B, C, W135, X and Y) can cause epidemics. The incubation period averages 3-4 d (range 1-10 d), which is the period of communicability. Bacteria can be found for 2-4 d in the nose and pharynx, and for up to 24 h after starting antibiotics. N. meningitidis is a leading cause of meningitis worldwide and a significant public health problem and dreaded disease in most countries. Morbidity and mortality rates from the disease remain high. Apart from epidemics, at least 1.2 million cases of bacterial meningitis are estimated to occur every year, 135,000 of which are fatal--of these, ~500,000 and ~50,000 respectively are caused by meningococci. Many outbreaks of meningococcal meningitis have been documented, with major outbreaks mainly seen in large cities of northern, western and eastern India like New Delhi, Mumbai, Kolkata and northeastern states. In 2011, 245 people died in India, the vast majority (179) in West Bengal, while 467 and 341 people in 2009 and 2010 respectively died of this disease. The meningococcal conjugate vaccines (MCV) are preferred for reasons of immunogenicity and persistence of immunity but are unavailable in India. Only the quadrivalent and bivalent meningococcal Ps vaccines (MPV) are available in India. The quadrivalent MPV is preferred for Haj pilgrims, international travelers and students in that it provides protection against emerging W-135 and Y disease in these areas. A single-dose 0.5mL injection is recommended.
Topics: Humans; India; Meningitis, Meningococcal; Meningococcal Vaccines; Vaccination; Vaccines, Conjugate
PubMed: 22906940
DOI: 10.4161/hv.21666 -
Pathogens and Global Health Jan 2014A number of countries now include meningococcal vaccines in their routine immunization programs. This review focuses on different approaches to including meningococcal... (Review)
Review
A number of countries now include meningococcal vaccines in their routine immunization programs. This review focuses on different approaches to including meningococcal vaccines in country programs across the world and their effect on the burden of invasive meningococcal disease (IMD) as reflected by pre and post-vaccine incidence rates in the last 20 years. Mass campaigns using conjugated meningococcal vaccines have lead to control of serogroup C meningococcal disease in the UK, Canada, Australia, Spain, Belgium, Ireland, and Iceland. Serogroup B disease, predominant in New Zealand, has been dramatically decreased, partly due to the introduction of an outer membrane vesicle (OMV) vaccine. Polysaccharide vaccines were used in high risk people in Saudi Arabia and Syria and in routine immunization in China and Egypt. The highest incidence region of the meningitis belt initiated vaccination with the serogroup A conjugate vaccine in 2010 and catch-up vaccination is ongoing. Overall results of this vaccine introduction are encouraging especially in countries with a moderate to high level of endemic disease. Continued surveillance is required to monitor effectiveness in countries that recently implemented these programs.
Topics: Female; Global Health; Humans; Immunization Programs; Incidence; Male; Mass Vaccination; Meningitis, Meningococcal; Meningococcal Infections; Meningococcal Vaccines; Neisseria meningitidis; Polysaccharides; Vaccines, Conjugate
PubMed: 24548156
DOI: 10.1179/2047773214Y.0000000126