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Nicole E Basta, Adel A F Mahmoud, Julian Wolfson, Alexander Ploss, Brigitte L Heller, Sarah Hanna, Peter Johnsen, Robin Izzo, Bryan T Grenfell, Jamie Findlow, Xilian Bai, Ray Borrow
Background In December 2013, a multicomponent meningococcal serogroup B (4CMenB) vaccine was used before licensure on the basis of special consideration by the Food and Drug Administration to respond to an outbreak of Neisseria meningitidis B at a U.S. university. Data suggested that vaccination would control the outbreak because isolates expressed antigens that were closely related to the vaccine antigens (factor H-binding protein [fHbp] and neisserial heparin-binding antigen). We quantified the immune responses induced by 4CMenB during the outbreak...
July 21, 2016: New England Journal of Medicine
Ashesh Gandhi, Paul Balmer, Laura J York
Neisseria meningitidis is a common cause of bacterial meningitis, often leading to permanent sequelae or death. N. meningitidis is classified into serogroups based on the composition of the bacterial capsular polysaccharide; the 6 major disease-causing serogroups are designated A, B, C, W, X, and Y. Four of the 6 disease-causing serogroups (A, C, Y, and W) can be effectively prevented with available quadrivalent capsular polysaccharide protein conjugate vaccines; however, capsular polysaccharide conjugate vaccines are not effective against meningococcal serogroup B (MnB)...
August 2016: Postgraduate Medicine
Suzana Bukovski, Paola Vacca, Anna Anselmo, Ivica Knezovic, Cecilia Fazio, Arianna Neri, Andrea Ciammaruconi, Antonella Fortunato, Anna Maria Palozzi, Silvia Fillo, Florigio Lista, Paola Stefanelli
In the last decade, the incidence of invasive meningococcal disease (IMD) in Croatia remained stable at approximately 1 case per 100 000 inhabitants, affecting mainly children aged ≤5 years. We report the molecular characterization of meningococci causing IMD occurring from June 2009 to January 2014 in Croatia. Genomic DNA from 50 clinical isolates was analysed for serogroup, multilocus sequence typing and allele type of the two outer membrane protein genes, porA and the iron-regulated fetA. Furthermore, 22 of them were characterized by using whole-genome sequencing to define the meningococcal vaccine four-component meningococcal serogroup B (4CMenB) antigen genes factor H-binding protein (fHbp), Neisseria heparin-binding antigen (nhba) and Neisseria adhesin A (nadA) and the antimicrobial target resistance genes for penicillin (penicillin binding protein 2, penA), ciprofloxacin (DNA gyrase subunit A, gyrA) and rifampicin (β-subunit of RNA polymerase, rpoB)...
September 2016: Journal of Medical Microbiology
Parvanè Kuhdari, Armando Stefanati, Silvia Lupi, Nicoletta Valente, Giovanni Gabutti
Invasive meningococcal disease (IMD) represents a severe risk for health. It can be considered the most dangerous vaccine-preventable disease due to the high probability of related permanent sequelae and death. The introduction in many countries of the conjugate vaccines against A, C, W135, and Y meningococcal serogroups influenced significantly the impact of the disease. Recently, the difficulties in obtaining an effective vaccine against meningococcal serogroup B (MenB) have been get over through the reverse vaccinology, enabling the recognition of some antigens providing a response against most of circulating MenB strains worldwide...
June 2016: Pathogens and Global Health
J M Langley, D M MacDougall, B A Halperin, A Swain, S A Halperin, K A Top, S A McNeil, D MacKinnon-Cameron, K Marty, G De Serres, E Dubé, J A Bettinger
An outbreak of Neisseria meningitidis serotype B infection occurred at a small residential university; public health announced an organizational vaccination program with the 4-component Meningococcal B (4CMenB) vaccine (Bexsero(TM), Novartis/GlaxoSmithKline Inc.) several days later. Since there were limited published data on reactogenicity of 4CMenB in persons over 17years of age, this study sought to conduct rapid surveillance of health events in vaccinees and controls using an online survey. Vaccine uptake was 84...
July 25, 2016: Vaccine
M Sadarangani, A J Pollard
Invasive disease caused by Neisseria meningitidis is potentially devastating, with a case fatality rate of 5-15% and high rates of significant sequelae among survivors after septicaemia or meningitis. Capsular group C (MenC) conjugate vaccines have been highly successful in achieving control of MenC disease across Europe, and some countries have also introduced quadrivalent MenACWY conjugate vaccines to reduce disease caused by groups A, W and Y in addition to C. These vaccines putatively elicit protective levels of bactericidal antibodies in all age groups, induce immunologic memory and reduce nasopharyngeal carriage, thereby leading to herd protection...
April 26, 2016: Clinical Microbiology and Infection
Sonia Budroni, Annett Kleinschmidt, Philip Boucher, Duccio Medini
UNLABELLED: The Serum Bactericidal Antibody assay with human complement (hSBA) using individual immune sera is a surrogate of protection for meningococcal vaccines. Strain coverage of 4CMenB, a licensed vaccine against serogroup B meningococcal (MenB) disease, has been extensively assessed in hSBA using pooled sera, directly or through the Meningococcal Antigen Typing System (MATS). The extent to which pooled-sera hSBA titres reflect individual protection is not yet fully understood. We analysed more than 17000 individual hSBA titres from infants and toddlers vaccinated with 4CMenB, pooled-serum hSBA titres from subsets therein and MATS data from a 40 strain panel representative of invasive MenB disease in England and Wales...
May 17, 2016: Vaccine
Raquel Abad, Verónica Medina, Maria Stella, Giuseppe Boccadifuoco, Maurizio Comanducci, Stefania Bambini, Alessandro Muzzi, Julio A Vázquez
BACKGROUND: A novel meningococcal multicomponent vaccine, 4CMenB (Bexsero®), has been approved in Europe, Canada, Australia and US. The potential impact of 4CMenB on strain coverage is being estimated by using Meningococcal Antigen Typing System (MATS), an ELISA assay which measures vaccine antigen expression and diversity in each strain. Here we show the genetic characterization and the 4CMenB potential coverage of Spanish invasive strains (collected during one epidemiological year) compared to other European countries and discuss the potential reasons for the lower estimate of coverage in Spain...
2016: PloS One
Izabela Waśko, Eva Hong, Rosita De Paola, Maria Stella, Monica Moschioni, Muhamed-Kheir Taha, Anna Skoczyńska
Neisseria meningitidis of serogroup B (MenB) is currently responsible for more than 70% of cases of invasive meningococcal disease (IMD) in Poland and Europe as a whole. The aim of this study was to estimate strain coverage of a multicomponent meningococcal serogroup B vaccine (4CMenB) in Poland; the meningococcal antigen typing system (MATS) was used to test a panel of 196 invasive MenB strains isolated in Poland in 2010 and 2011. The strains were also characterized by MLST and sequencing of porA, factor H-binding protein (fHbp), Neisserial heparin-binding antigen (nhba) and Neisserial adhesin A (nadA) genes...
January 20, 2016: Vaccine
Jamie Findlow
Meningococcal disease remains a feared and devastating cause of sepsis and meningitis. Disease incidence is highest among infants and children although a significant burden of disease is experienced by adolescents, young adults and those with specific risk-factors. Prevention of disease against capsular groups A, C, W and Y; 4 of the 5 most pathogenic groups is achievable using capsular polysaccharide vaccines. It has only recently been possible to provide protection against capsular group B (MenB) strains following the licensure of a 4 component group B vaccine (4CMenB) in Europe in 2013...
2016: Human Vaccines & Immunotherapeutics
Chiara Mameli, Erica Galli, Cecilia Mantegazza, Valentina Fabiano, Gian Vincenzo Zuccotti
Neisseria meningitidis serogroup B is the main cause for meningococcal invasive disease in many parts of the world. Since 2013, a new multicomponent vaccine against meningococcal serogroup B (4CMenB) has been licensed in Europe, Australia, Canada, Chile, Uruguay, USA and Brazil with different immunization schedules. Clinical trials involving adults, adolescents, children and infants showed 4CMenB has a good immunogenicity and safety profile. Strain coverage estimates are similar to or better than other recently approved vaccines, ranging from 66% in Canada to 91% in Unites States...
2015: Future Microbiology
Tobias Tenenbaum, Johanna Niessen, Horst Schroten
The 4-component meningococcal serogroup B vaccine 4CMenB (Bexsero) is the first vaccine against this serogroup and has been approved by licensing authorities in Europe, Canada and Australia. Therefore, the vaccine may enter soon nationwide vaccine recommendation schemes. We report on a case of a 5-month-old infant who developed prolonged upper extremity dysfunction after the second injection of the 4CMenB vaccine in the left deltoid muscle and was concomitantly applied with 2 routine vaccinations. Myositis, periostitis, (peri-) vasculitis and axillary inflammation were confirmed by magnetic resonance imaging...
January 2016: Pediatric Infectious Disease Journal
Hirotaka Yamashiro, Nora Cutcliffe, Simon Dobson, David Fisman, Ronald Gold
As key stakeholders in immunization policy decisions, the Pediatricians of Ontario held an accredited conference on January 18, 2014, to discuss prevention of invasive meningococcal disease. Five key recommendations were put forth regarding immunization strategies to protect children from meningococcal serogroup B disease. The recently approved four-component meningococcal B (4CMenB) vaccine should be recommended and funded as part of Ontario's routine immunization schedule and should also be mandated for school attendance...
July 2015: Canadian Journal of Infectious Diseases & Medical Microbiology
Susanna Esposito, Claudia Tagliabue, Samantha Bosis
Neisseria meningitidis is a Gram-negative pathogen that actively invades its human host and leads to the development of life-threatening pathologies. One of the leading causes of death in the world, N. meningitidis can be responsible for nearly 1,000 new infections per 100,000 subjects during an epidemic period. The bacterial species are classified into 12 serogroups, five of which (A, B, C, W, and Y) cause the majority of meningitides. The three purified protein conjugate vaccines currently available target serogroups A, C, W, and Y...
2015: Journal of Immunology Research
Alexander Domnich, Roberto Gasparini, Daniela Amicizia, Giuseppe Boccadifuoco, Marzia Monica Giuliani, Donatella Panatto
Development of the 4-component meningococcal serogroup B vaccine (4CMenB) has required new assays for the reliable evaluation of the expression and cross-reactivity of those specific antigen variants that are predicted to be targeted by bactericidal antibodies elicited by the vaccine in different isolates. Existing laboratory techniques, such as multilocus sequence typing, are poorly suited to this purpose, since they do not provide information on the contribution of single vaccine components and therefore cannot be applied to estimate the potential coverage of the multicomponent vaccine...
2015: Journal of Immunology Research
Eve Dubé, Dominique Gagnon, Denis Hamel, Sylvie Belley, Hélène Gagné, Nicole Boulianne, Monique Landry, Julie A Bettinger
A mass vaccination campaign with the 4CMenB vaccine (Bexsero®; Novartis Pharmaceutical Canada Inc) was launched in a serogroup B endemic area in Quebec. A telephone survey was conducted to assess parental and adolescent opinions about the acceptability of the vaccine. Intent to receive the vaccine or vaccine receipt was reported by the majority of parents (93%) and adolescents (75%). Meningitis was perceived as being a dangerous disease by the majority of parents and adolescents. The majority of respondents also considered the 4CMenB vaccine to be safe and effective...
May 2015: Canadian Journal of Infectious Diseases & Medical Microbiology
Kirsten P Perrett, Jodie McVernon, Peter C Richmond, Helen Marshall, Michael Nissen, Allison August, Sandra Percell, Daniela Toneatto, Terry Nolan
BACKGROUND: For decades, a broadly effective vaccine against serogroup B Neisseria meningitidis (MenB) has remained elusive. Recently, a four-component recombinant vaccine (4CMenB) has been developed and is now approved in Europe, Canada, Australia and some Latin American countries. This phase III, randomized study evaluated the lot consistency, early immune responses and the safety profile of 4CMenB in 11 to 17-year-old adolescents in Australia and Canada (NCT01423084). METHODS: In total, 344 adolescents received two doses of one of 2 lots of 4CMenB, 1-month apart...
September 22, 2015: Vaccine
Keith D Poore, Chris T Bauch
BACKGROUND: Neisseria meningitidis (Nm) is a pathogen of multiple serogroups that is highly prevalent in many populations. Serogroups associated with invasive meningococcal disease (IMD) in Canada, for example, include A, B, C, W-135, X and Y. IMD is a rare but serious outcome of Nm infection, and can be prevented with vaccines that target certain serogroups. This has stimulated the development of dynamic models to evaluate vaccine impact. However, these models typically aggregate the various Nm serogroups into a small number of combined groups, instead of modelling each serogroup individually...
2015: BMC Infectious Diseases
Dennis K S Law, Brigitte Lefebvre, Rodica Gilca, Saul Deng, Jianwei Zhou, Philippe De Wals, Raymond S W Tsang
BACKGROUND: The epidemiology of invasive meningococcal disease (IMD) in Québec, Canada, has been dominated in the past decade by a clone of serogroup B (MenB) Neisseria meningitidis defined by multi-locus sequence typing (MLST) as sequence type (ST)-269. With the licensure of a new MenB vaccine Bexsero (4CMenB) in Canada, this study characterized invasive N. meningitidis recovered in Québec from 2009 to 2013, with an objective to examine the diversity of the 4CMenB vaccine antigens...
2015: BMC Microbiology
Jan T Poolman, Peter Richmond
Vaccines targeting Neisseria meningitidis serogroup B (MenB) have been attempted for 40 years. Monovalent outer membrane vesicle vaccines targeted at epidemic outbreaks have been successfully developed. Newer vaccines aim to induce antibodies to cross-reactive antigens, such as factor H binding protein (rLP2086) or a mix of outer membrane vesicle, factor H binding protein and other minor antigens (4CMenB). The true protective coverage among circulating MenB isolates afforded by these vaccines is unknown. Carefully conducted Phase IV post-implementation evaluations designed to measure specific effectiveness against major circulating MenB clonal lineages are needed to address the critical question of which antigens are linked to protection...
2015: Expert Review of Vaccines
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