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Daniela Toneatto, Mariagrazia Pizza, Vega Masignani, Rino Rappuoli
The successful development of two broadly protective vaccines targeting Neisseria meningitidis serogroup B (MenB); 4CMenB and rLP2086, is the most significant recent advance in meningococcal disease prevention. Areas covered: Here we review the principles underlying the development of each vaccine and the novel methods used to estimate vaccine coverage. We update clinical and post-licensure experience with 4CMenB and rLP2086. Expert commentary: The immunogenicity and acceptable safety profile of 4CMenB and rLP2086 has been demonstrated in clinical trials...
May 2017: Expert Review of Vaccines
Carolyn M Buckwalter, Elissa G Currie, Raymond S W Tsang, Scott D Gray-Owen
Background: The 4CMenB vaccine is an outer membrane vesicle and recombinant protein-based vaccine recently licensed to protect against serogroup B meningococcal disease. It remains unknown whether this vaccine will prevent carriage or transmission, key aspects in long-term vaccine success and disease eradication. Methods: Employing a 'humanized' transgenic mouse model of nasal colonization, a systematic approach was taken to estimate the potential for carriage prevention against antigenically-diverse Neisseria meningitidis strains, and to compare this protection to an invasive meningococcal disease challenge model...
March 27, 2017: Journal of Infectious Diseases
Sydel R Parikh, Lynne Newbold, Stephanie Slater, Maria Stella, Monica Moschioni, Jay Lucidarme, Rosita De Paola, Maria Giuliani, Laura Serino, Stephen J Gray, Stephen A Clark, Jamie Findlow, Mariagrazia Pizza, Mary E Ramsay, Shamez N Ladhani, Ray Borrow
BACKGROUND: The UK introduced 4CMenB-a multicomponent vaccine against serogroup B meningococcal disease-into the national infant immunisation programme in September, 2015. The Meningococcal Antigen Typing System (MATS) was used to estimate coverage by 4CMenB of invasive meningococcal group B isolates obtained during 2007-08 in England and Wales (MATS coverage). We aimed to repeat the MATS survey for invasive meningococcal group B isolates obtained during 2014-15, before 4CMenB introduction; compare strain coverage between 2007-08 and 2014-15; and investigate associations between MATS coverage, age, region, and disease outcomes...
March 30, 2017: Lancet Infectious Diseases
Raquel Abad, Julio Vazquez
No abstract text is available yet for this article.
March 30, 2017: Lancet Infectious Diseases
Ian M Feavers, Martin C J Maiden
The widespread use of meningococcal polysaccharide conjugate vaccines has highlighted the challenge of providing protection against serogroup B disease. Over a period of four decades vaccine development has focused on sub-capsular, protein antigens, first with outer membrane vesicle (OMV) vaccines against epidemic outbreaks, and more recently on new multicomponent vaccines designed to offer better cross-protection against the antigenically diverse strains responsible for endemic disease. Because of the low incidence of meningococcal disease, the protective efficacy of these vaccines has not been determined in clinical studies and their licensure has been based on serological data; however, the serological assays used to predict protective coverage have limitations...
March 29, 2017: Clinical and Vaccine Immunology: CVI
Angelika Banzhoff
Meningococcal disease is rare, easily misdiagnosed, and potentially deadly. Diagnosis in the early stages is difficult and the disease often progresses extremely rapidly. In North America, the incidence of invasive meningococcal disease (IMD) is highest in infants and young children, with a secondary peak in adolescents, a population predominantly responsible for the carriage of disease. Neisseria meningitidis serogroup B (MenB) accounts for a large proportion of meningococcal disease in North America, with documented outbreaks in three universities in the United States (US) during 2008-2013...
February 2017: Therapeutic Advances in Vaccines
Jamie Findlow, Ray Borrow
Meningococcal serogroup B vaccines have been licensed on the basis of safety and immunogenicity data without efficacy studies. Establishing the breadth of coverage of these new vaccines has proved difficult and relied on correlates of protection such as serum bactericidal antibody and a novel assays such as the meningococcal antigen typing system. The demonstration of the effectiveness of 4CMenB in a reduced infant dose schedule together with detailed phenotypic and genotypic information gained from isolates and sera from cases of invasive MenB disease in vaccine eligible infants will enable a re-evaluation of our knowledge of correlates of protection...
March 1, 2017: Pathogens and Disease
Marco Aurelio P Safadi, Federico Martinon-Torres, Lily Yin Weckx, Edson Duarte Moreira, Eduardo Jorge da Fonseca Lima, Ilhem Mensi, Marco Calabresi, Daniela Toneatto
BACKGROUND: After implementation of routine infant MenC vaccination, MenB remains a serious cause of meningococcal disease, yet to be targeted by vaccination programs in several countries. This study (NCT01339923) investigated the immunogenicity and safety of MenC CRM-conjugated vaccine (MenC-CRM) concomitantly administered with MenB vaccine (4CMenB). METHODS: Infants (N=251) were randomised 1:1 to receive 4CMenB and MenC-CRM (Group 1) or MenC-CRM alone (Group 2) at 3 and 5months (M3, M5) and a booster at 12months of age (M12), and pneumococcal vaccine at M3, M5, M7, M12...
March 15, 2017: Vaccine
Sydel R Parikh, Nick J Andrews, Kazim Beebeejaun, Helen Campbell, Sonia Ribeiro, Charlotte Ward, Joanne M White, Ray Borrow, Mary E Ramsay, Shamez N Ladhani
BACKGROUND: In September, 2015, the UK became the first country to introduce the multicomponent group B meningococcal (MenB) vaccine (4CMenB, Bexsero) into a publicly funded national immunisation programme. A reduced two-dose priming schedule was offered to infants at 2 months and 4 months, alongside an opportunistic catch-up for 3 month and 4 month olds. 4CMenB was predicted to protect against 73-88% of MenB strains. We aimed to assess the effectiveness and impact of 4CMenB in vaccine-eligible infants in England...
December 3, 2016: Lancet
Nicole E Basta, Hannah Christensen
No abstract text is available yet for this article.
December 3, 2016: Lancet
Mildred A Iro, Matthew D Snape, Merryn Voysey, Sena Jawad, Adam Finn, Paul T Heath, Gianni Bona, Susanna Esposito, Javier Diez-Domingo, Roman Prymula, Adefowope Odueyungbo, Daniela Toneatto, Peter Dull, Andrew J Pollard
BACKGROUND: 4CMenB is immunogenic in infants and toddlers. We assessed persistence of human complement serum bactericidal activity (hSBA) following a fourth dose administered at 12, 18 or 24months and characterised the antibody response to a fifth dose administered at 4years of age. METHODS: A phase 3, open label, multi-centre extension to a randomised controlled trial conducted in four countries (number of centres): Czech Republic (nineteen), Italy (four), Spain (four) and the United Kingdom (four)...
January 5, 2017: Vaccine
Robert C Read, Peter Dull, Xilian Bai, Kate Nolan, Jamie Findlow, Rohit Bazaz, Annett Kleinschmidt, Maggie McCarthy, Huajun Wang, Daniela Toneatto, Ray Borrow
BACKGROUND: University students have high rates of pharyngeal carriage of Neisseria meningitidis. Interruption of carriage acquisition is an important mechanism of vaccines for inducing herd protection. 4CMenB and MenACWY-CRM vaccines have been shown to be immunogenic against meningococcal serogroups B and ACWY respectively in younger age groups, and also to elicit a modest impact on meningococcal carriage in vaccinated students. However, vaccine responses in university students and the impact of serum bactericidal antibody (SBA) titers on meningococcal carriage are undetermined...
January 11, 2017: Vaccine
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
BACKROUND: 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...
December 1, 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
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