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Meningococcal Serogroup B Vaccine

Helen S Marshall, Peter C Richmond, Johannes Beeslaar, Qin Jiang, Kathrin U Jansen, Maria Garcés-Sánchez, Federico Martinón-Torres, Leszek Szenborn, Jacek Wysocki, Joseph Eiden, Shannon L Harris, Thomas R Jones, Su-San Lee, John L Perez
BACKGROUND: Bivalent rLP2086 is a recombinant factor H binding protein-based vaccine approved in the USA for prevention of meningococcal serogroup B disease in 10-25-year-olds. We aimed to assess the persistence of bactericidal antibodies up to 4 years after a three-dose schedule of bivalent rLP2086. METHODS: We did this randomised, single-blind, placebo-controlled, phase 2 trial at 25 sites in Australia, Poland, and Spain. In stage 1 of the study (February, 2009-May, 2010), healthy adolescents (aged 11-18 years) were randomly assigned, via an interactive voice and web-response system with computer-generated sequential random numbers, to receive either ascending doses of vaccine (60 μg, 120 μg, and 200 μg) or placebo at months 0, 2, and 6...
October 10, 2016: Lancet Infectious Diseases
Dan M Granoff, Serena Giuntini, Flor A Gowans, Eduardo Lujan, Kelsey Sharkey, Peter T Beernink
Meningococcal factor H-binding protein (FHbp) is an antigen in 2 serogroup B meningococcal vaccines. FHbp specifically binds human and some nonhuman primate complement FH. To investigate the effect of binding of FH to FHbp on protective antibody responses, we immunized infant rhesus macaques with either a control recombinant FHbp antigen that bound macaque FH or a mutant antigen with 2 amino acid substitutions and >250-fold lower affinity for FH. The mutant antigen elicited 3-fold higher serum IgG anti-FHbp titers and up to 15-fold higher serum bactericidal titers than the control FHbp vaccine...
2016: JCI Insight
Sina Brückner, Selidji Todagbe Agnandji, Johannes Elias, Stefan Berberich, Emmanuel Bache, José Fernandes, Marguerite Massinga Loembe, Johanna Hass, Bertrand Lell, Benjamin Mordmüller, Ayola Akim Adegnika, Peter Kremsner, Meral Esen
BACKGROUND: We recently described the effect of a single-dose antihelminthic treatment on vaccine immunogenicity to a seasonal influenza vaccine. Here we report the effect of antihelminthics on the immunogenicity of a meningococcal vaccine and a cholera vaccine in primary school children living in Lambaréné, Gabon. Since infection with helminths remains a major public health problem and the influence on cognitive and physical development as well as the immunomodulatory effects are well established, we investigated if a single-dose antihelminthic treatment prior to immunization positively influences antibody titers and vaccine-specific memory B-cells...
October 17, 2016: Vaccine
Yin Luo, Olga V Friese, Herbert A Runnels, Lakshmi Khandke, Gary Zlotnick, Ann Aulabaugh, Thomas Gore, Eugene Vidunas, Stephen W Raso, Elena Novikova, Emilia Byrne, Michael Schlittler, Donald Stano, Robert L Dufield, Sandeep Kumar, Annaliesa S Anderson, Kathrin U Jansen, Jason C Rouse
Trumenba (bivalent rLP2086) is a vaccine licensed for the prevention of meningococcal meningitis disease caused by Neisseria meningitidis serogroup B (NmB) in individuals 10-25 years of age in the USA. The vaccine is composed of two factor H binding protein (fHbp) variants that were recombinantly expressed in Escherichia coli as native lipoproteins: rLP2086-A05 and rLP2086-B01. The vaccine was shown to induce potent bactericidal antibodies against a broad range of NmB isolates expressing fHbp that were different in sequence from the fHbp vaccine antigens...
September 7, 2016: AAPS Journal
(no author information available yet)
This policy statement provides recommendations for the prevention of serogroup B meningococcal disease through the use of 2 newly licensed serogroup B meningococcal vaccines: MenB-FHbp (Trumenba; Wyeth Pharmaceuticals, a subsidiary of Pfizer, Philadelphia, PA) and MenB-4C (Bexsero; Novartis Vaccines, Siena, Italy). Both vaccines are approved for use in persons 10 through 25 years of age. MenB-FHbp is licensed as a 2- or 3-dose series, and MenB-4C is licensed as a 2-dose series for all groups. Either vaccine is recommended for routine use in persons 10 years and older who are at increased risk of serogroup B meningococcal disease (category A recommendation)...
September 2016: Pediatrics
Lucy Breakwell, Tara M Vogt, Debbie Fleming, Mary Ferris, Elizabeth Briere, Amanda Cohn, Jennifer L Liang
PURPOSE: During March-November 2013, five cases of serogroup B meningococcal disease occurred among University A undergraduates. The Centers for Disease Control and Prevention used the unlicensed MenB-4C (Bexsero, Novartis Vaccines), a serogroup B meningococcal vaccine, to control the outbreak. All undergraduates (n = 19,257) were offered two doses; 51% of undergraduates received ≥1 dose of MenB-4C. We conducted a knowledge, attitudes, and practice survey to understand which factors and sources of information impacted their decision on whether or not to receive vaccine...
October 2016: Journal of Adolescent Health: Official Publication of the Society for Adolescent Medicine
Carina Brehony, Charlene M C Rodrigues, Ray Borrow, Andrew Smith, Robert Cunney, E Richard Moxon, Martin C J Maiden
Serogroup B is the only major disease-associated capsular group of Neisseria meningitidis for which no protein-polysaccharide conjugate vaccine is available. This has led to the development of multi-component protein-based vaccines that target serogroup B invasive meningococcal disease (IMD), including Bexsero®, which was implemented for UK infants in 2015, and Trumenba®. Given the diversity of meningococcal protein antigens, post-implementation surveillance of IMD isolates, including characterisation of vaccine antigens, is essential for assessing the effectiveness of such vaccines...
September 7, 2016: Vaccine
María Victoria Humbert, Miao-Chiu Hung, Renee Phillips, Charlene Akoto, Alison Hill, Wei-Ming Tan, John Edward Heckels, Myron Christodoulides
The cbf gene from Neisseria meningitidis strain MC58 encoding the putative Cell Binding Factor (CBF, NMB0345/NEIS1825) protein was cloned into the pRSETA system and a ~36-kDa recombinant (r)CBF protein expressed in Escherichia coli and purified by metal affinity chromatography. High titres of rCBF antibodies were induced in mice following immunization with rCBF-saline, rCBF-Al(OH)3, rCBF-Liposomes or rCBF-Zwittergent (Zw) 3-14 micelles, both with and without incorporated monophosphoryl lipid A (MPLA) adjuvant...
2016: PloS One
Jerome H Kim
Proving the clinical efficacy of Neisseria meningitidis serogroup B (MenB) vaccines has been difficult. There is substantial genetic (and corresponding antigenic) diversity, and serogroup B meningococcal disease is both uncommon and in decline in countries where the burden is well understood. The..
July 21, 2016: New England Journal of Medicine
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
Mehmet Ceyhan, Yasemin Ozsurekci, Nezahat Gürler, Eda Karadag Oncel, Yıldız Camcioglu, Nuran Salman, Melda Celik, Melike Keser Emiroglu, Fatih Akin, Hasan Tezer, Aslinur Ozkaya Parlakay, Nilden Tuygun, Diyar Tamburaci, Ener Cagri Dinleyici, Adem Karbuz, Ünal Uluca, Emre Alhan, Ümmühan Çay, Zafer Kurugol, Nevin Hatipoğlu, Rengin Şiraneci, Tolga İnce, Gülnar Sensoy, Nursen Belet, Enes Coskun, Fatih Yilmaz, Mustafa Hacimustafaoglu, Solmaz Celebi, Ümit Celik, Metehan Ozen, Aybüke Akaslan, İlker Devrim, Necdet Kuyucu, Fatmanur Öz, Sefika Elmas Bozdemir, Ahu Kara
This is an observational epidemiological study to describe causes of bacterial meningitis among persons between 1 month and 18 years of age who are hospitalized with suspected bacterial meningitis in 7 Turkish regions. covering 32% of the entire population of Turkey. We present here the results from 2013 and 2014. A clinical case with meningitis was defined according to followings: any sign of meningitis including fever, vomiting, headache, and meningeal irritation in children above one year of age and fever without any documented source, impaired consciousness, prostration and seizures in those <1 year of age...
July 25, 2016: Human Vaccines & Immunotherapeutics
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
Stephen I Pelton
Invasive meningococcal disease (IMD) caused by Neisseria meningitidis is associated with high morbidity and mortality. Although IMD incidence is highest in infants, a second peak occurs in adolescents/young adults. The incidence of IMD and the predominant disease-causing meningococcal serogroups vary worldwide. Epidemiologic data have guided the development of meningococcal vaccines to reduce the IMD burden. In Europe, serogroup C IMD has been substantially reduced since the introduction of a serogroup C conjugate vaccine...
August 2016: Journal of Adolescent Health: Official Publication of the Society for Adolescent Medicine
Carol J Baker
Neisseria meningitidis is a common cause of bacterial meningitis and septicemia that can lead to permanent sequelae or death. N meningitidis is classified into serogroups based on the composition of the capsular polysaccharide, with serogroups A, B, C, W, X, and Y recognized as the major disease-causing organisms. The unpredictability of infection coupled with the poor prognosis for some patients suggests immunization as an effective preventive strategy. Importantly, four of the six disease-causing serogroups (A, C, Y, and W) may be prevented with available quadrivalent capsular polysaccharide-protein conjugate vaccines; these vaccines have been successfully implemented into immunization programs in the United States...
August 2016: Journal of Adolescent Health: Official Publication of the Society for Adolescent Medicine
Shakeel Mowlaboccus, Timothy T Perkins, Helen Smith, Theo Sloots, Sarah Tozer, Lydia-Jessica Prempeh, Chin Yen Tay, Fanny Peters, David Speers, Anthony D Keil, Charlene M Kahler
Neisseria meningitidis is the causative agent of invasive meningococcal disease (IMD). The BEXSERO® vaccine which is used to prevent serogroup B disease is composed of four sub-capsular protein antigens supplemented with an outer membrane vesicle. Since the sub-capsular protein antigens are variably expressed and antigenically variable amongst meningococcal isolates, vaccine coverage can be estimated by the meningococcal antigen typing system (MATS) which measures the propensity of the strain to be killed by vaccinated sera...
2016: PloS One
Bruce Atkinson, Ashesh Gandhi, Paul Balmer
Invasive meningococcal disease caused by Neisseria meningitidis presents a significant public health concern. Meningococcal disease is rare but potentially fatal within 24 hours of onset of illness, and survivors may experience permanent sequelae. This review presents the epidemiology, incidence, and outbreak data for invasive meningococcal disease in the United States since 1970, and it highlights recent changes in vaccine recommendations to prevent meningococcal disease. Relevant publications were obtained by database searches for articles published between January 1970 and July 2015...
August 2016: Pharmacotherapy
M Tontini, M R Romano, D Proietti, E Balducci, F Micoli, C Balocchi, L Santini, V Masignani, F Berti, P Costantino
Glycoconjugate vaccines are made of carbohydrate antigens covalently bound to a carrier protein to enhance their immunogenicity. Among the different carrier proteins tested in preclinical and clinical studies, five have been used so far for licensed vaccines: Diphtheria and Tetanus toxoids, the non-toxic mutant of diphtheria toxin CRM197, the outer membrane protein complex of Neisseria meningitidis serogroup B and the Protein D derived from non-typeable Haemophilus influenzae. Availability of novel carriers might help to overcome immune interference in multi-valent vaccines containing several polysaccharide-conjugate antigens, and also to develop vaccines which target both protein as well saccharide epitopes of the same pathogen...
July 29, 2016: Vaccine
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
Luigi Scietti, Katia Sampieri, Irene Pinzuti, Erika Bartolini, Barbara Benucci, Alessia Liguori, Andreas F Haag, Paola Lo Surdo, Werner Pansegrau, Vincenzo Nardi-Dei, Laura Santini, Seguinde Arora, Xavier Leber, Simonetta Rindi, Silvana Savino, Paolo Costantino, Domenico Maione, Marcello Merola, Pietro Speziale, Matthew J Bottomley, Fabio Bagnoli, Vega Masignani, Mariagrazia Pizza, Meike Scharenberg, Jean-Marc Schlaeppi, Mikkel Nissum, Sabrina Liberatori
During bacterial pathogenesis extensive contacts between the human and the bacterial extracellular proteomes take place. The identification of novel host-pathogen interactions by standard methods using a case-by-case approach is laborious and time consuming. To overcome this limitation, we took advantage of large libraries of human and bacterial recombinant proteins. We applied a large-scale protein microarray-based screening on two important human pathogens using two different approaches: (I) 75 human extracellular proteins were tested on 159 spotted Staphylococcus aureus recombinant proteins and (II) Neisseria meningitidis adhesin (NadA), an important vaccine component against serogroup B meningococcus, was screened against ≈2300 spotted human recombinant proteins...
2016: Scientific Reports
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