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Meningococcal Serogroup B Vaccine

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https://www.readbyqxmd.com/read/27912986/a-phase-iii-observer-blind-randomized-controlled-study-to-evaluate-the-immune-response-and-the-correlation-with-nasopharyngeal-carriage-after-immunization-of-university-students-with-a-quadrivalent-meningococcal-acwy-glycoconjugate-or-serogroup-b-meningococcal
#1
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...
November 29, 2016: Vaccine
https://www.readbyqxmd.com/read/27884478/vaccine-provision-delivering-sustained-widespread-use
#2
Scott Preiss, Nathalie Garçon, Anthony L Cunningham, Richard Strugnell, Leonard R Friedland
The administration of a vaccine to a recipient is the final step in a development and production process that may have begun several decades earlier. Here we describe the scale and complexity of the processes that brings a candidate vaccine through clinical development to the recipient. These challenges include ensuring vaccine quality (between 100 and 500 different Quality Control tests are performed during production to continually assess safety, potency and purity); making decisions about optimal vaccine presentation (pre-filled syringes versus multi-dose vials) that affect capacity and supply; and the importance of maintaining the vaccine cold chain (most vaccines have stringent storage temperature requirements necessary to maintain activity and potency)...
November 21, 2016: Vaccine
https://www.readbyqxmd.com/read/27881489/kinetics-of-meningococcal-serogroup-c-specific-functional-antibody-levels-up-to-15-years-after-a-single-immunization-with-a-meningococcal-serogroup-c-conjugate-vaccine-during-adolescence
#3
Susanne P Stoof, Mariëtte B van Ravenhorst, Debbie M van Rooijen, Richarda M de Voer, Fiona R M van der Klis, Greet J Boland, Elisabeth A M Sanders, Guy A M Berbers, Peter F Teunis
BACKGROUND: Adolescent vaccination is now considered the key factor to offer direct protection against meningococcal disease but also to reduce carriage and transmission and in this way establish herd protection. This study estimated age-dependent patterns in functional meningococcal serogroup C (MenC) antibody kinetics after primary MenC conjugate (MenCC) vaccination in adolescents. METHODS: Serum samples (n=1676) were drawn between 2006-2011 from individuals aged 9-18 years at time of primary MenCC vaccination in 2002...
November 23, 2016: Clinical and Vaccine Immunology: CVI
https://www.readbyqxmd.com/read/27861618/meningococcal-carriage-among-adolescents-after-mass-meningococcal-c-conjugate-vaccination-campaigns-in-salvador-brazil
#4
Amélia Maria Pithon Borges Nunes, Guilherme Sousa Ribeiro, Ítalo Eustáquio Ferreira, Ana Rafaela Silva Simões Moura, Ridalva Dias Martins Felzemburgh, Ana Paula Silva de Lemos, Mitermayer Galvão Reis, José Cassio de Moraes, Leila Carvalho Campos
Neisseria meningitidis is a commensal bacterium of the human nasopharynx. In rare cases, it penetrates the mucosa, entering the blood stream and causing various forms of disease. Meningococcal conjugate vaccines can prevent invasive disease not only by direct effect in vaccinated individuals but also by herd protection, preventing acquisition of carriage, which interrupts transmission and leads to protection of unvaccinated persons. In 2010 in Salvador, Brazil, an outbreak of group C meningococcal disease led to a mass meningococcal serogroup C conjugate vaccination drive, targeting those <5 and 10-24 years of age...
2016: PloS One
https://www.readbyqxmd.com/read/27847367/serum-bactericidal-antibody-responses-of-adults-immunized-with-the-menb-4c-vaccine-against-genetically-diverse-serogroup-b-meningococci
#5
Serena Giuntini, Eduardo Lujan, Malick M Gibani, Christina Dold, Christine S Rollier, Andrew J Pollard, Dan M Granoff
BACKGROUND: MenB-4C is a meningococcal vaccine for prevention of serogroup B disease. The vaccine contains Factor H binding protein (FHbp) and three other antigens that can elicit serum bactericidal activity (SBA). For vaccine licensure, efficacy was inferred from SBA responses against three indicator strains. The relation between the results and broad protection against circulating genetically diverse strains is not known. METHODS: 20 adults were immunized with two doses of MenB-4C given 1 to 2 months apart...
November 9, 2016: Clinical and Vaccine Immunology: CVI
https://www.readbyqxmd.com/read/27846061/neisseria-meningitidis-serogroup-b-vaccine-bivalent-rlp2086-induces-broad-serum-bactericidal-activity-against-diverse-invasive-disease-strains-including-outbreak-strains
#6
Shannon L Harris, Robert G K Donald, Julio Cesar Hawkins, Cuiwen Tan, Robert O'Neill, Lisa K McNeil, John L Perez, Annaliesa S Anderson, Kathrin U Jansen, Thomas R Jones
BACKGROUND: Bivalent rLP2086 (Trumenba®), 1 of 2 meningococcal serogroup B (MnB) vaccines recently approved in the United States for prevention of MnB disease in individuals aged 10-25 years, is composed of 2 lipidated factor H binding proteins (fHBPs) from subfamilies A and B. This study evaluated the breadth of MnB strain coverage elicited by bivalent rLP2086 measured with serum bactericidal assays using human complement (hSBAs). METHODS: hSBA responses to diverse MnB clinical strains circulating in the United States and Europe (n=23), as well as recent US university outbreak strains (n=4), were evaluated...
November 11, 2016: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/27832151/nationwide-trends-in-bacterial-meningitis-before-the-introduction-of-13-valent-pneumococcal-conjugate-vaccine-burkina-faso-2011-2013
#7
Dinanibè Kambiré, Heidi M Soeters, Rasmata Ouédraogo-Traoré, Isaïe Medah, Lassana Sangare, Issaka Yaméogo, Guetawendé Sawadogo, Abdoul-Salam Ouédraogo, Soumeya Hema-Ouangraoua, Lesley McGee, Velusamy Srinivasan, Flavien Aké, Malika Congo-Ouédraogo, Soufian Sanou, Absatou Ky Ba, Ryan T Novak, Chris Van Beneden
BACKGROUND: Following introduction of Haemophilus influenzae type b vaccine in 2006 and serogroup A meningococcal conjugate vaccine in 2010, Streptococcus pneumoniae (Sp) became the leading cause of bacterial meningitis in Burkina Faso. We describe bacterial meningitis epidemiology, focusing on pneumococcal meningitis, before 13-valent pneumococcal conjugate vaccine (PCV13) introduction in the pediatric routine immunization program in October 2013. METHODS: Nationwide population-based meningitis surveillance collects case-level demographic and clinical information and cerebrospinal fluid (CSF) laboratory results...
2016: PloS One
https://www.readbyqxmd.com/read/27817957/long-term-persistence-of-protective-antibodies-in-dutch-adolescents-following-a-meningococcal-serogroup-c-tetanus-booster-vaccination
#8
Mariëtte B van Ravenhorst, Axel Bonacic Marinovic, Fiona R M van der Klis, Debbie M van Rooijen, Marjan van Maurik, Susanne P Stoof, Elisabeth A M Sanders, Guy A M Berbers
INTRODUCTION: Due to waning immunity, infant vaccination with meningococcal serogroup C conjugated (MenCC) vaccines is insufficient to maintain long-term individual protection. Adolescent booster vaccination is thought to offer direct protection against invasive meningococcal disease (IMD) but also to reduce meningococcal carriage and transmission and in this way establish herd protection in the population. Previously, we studied antibody levels after adolescent MenCC booster vaccination...
December 7, 2016: Vaccine
https://www.readbyqxmd.com/read/27808594/immunogenicity-and-safety-among-laboratory-workers-vaccinated-with-bexsero%C3%A2-vaccine
#9
Eva Hong, Aude Terrade, Muhamed-Kheir Taha
Neisseria meningitidis serogroup B is the most prevalent cause of invasive meningococcal disease in Europe and members of laboratories working on meningococci are at risk due to frequent handling. Recommendation for anti-meningococcal vaccination among these workers has been recently updated upon the licensure in Europe of Bexsero® vaccine. We tested the immunogenicity and safety of this vaccine among adults laboratory staff using the recommended schedule of two doses at 5 weeks interval. The vaccine was well tolerated in spite of frequent local side effects and all participants reported at least one side effect after each dose...
November 3, 2016: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/27745812/meningococcal-serogroup-b-specific-responses-after-vaccination-with-bivalent-rlp2086-4-year-follow-up-of-a-randomised-single-blind-placebo-controlled-phase-2-trial
#10
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
https://www.readbyqxmd.com/read/27668287/enhanced-protective-antibody-to-a-mutant-meningococcal-factor-h-binding-protein-with-low-factor-h-binding
#11
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
https://www.readbyqxmd.com/read/27642131/a-single-dose-antihelminthic-treatment-does-not-influence-immunogenicity-of-a-meningococcal-and-a-cholera-vaccine-in-gabonese-school-children
#12
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
https://www.readbyqxmd.com/read/27604766/the-dual-role-of-lipids-of-the-lipoproteins-in-trumenba-a-self-adjuvanting-vaccine-against-meningococcal-meningitis-b-disease
#13
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
https://www.readbyqxmd.com/read/27573083/recommendations-for-serogroup-b-meningococcal-vaccine-for-persons-10-years-and-older
#14
(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
https://www.readbyqxmd.com/read/27523976/understanding-factors-affecting-university-a-students-decision-to-receive-an-unlicensed-serogroup-b-meningococcal-vaccine
#15
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
https://www.readbyqxmd.com/read/27521232/distribution-of-bexsero%C3%A2-antigen-sequence-types-basts-in-invasive-meningococcal-disease-isolates-implications-for-immunisation
#16
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
https://www.readbyqxmd.com/read/27505005/vaccine-potential-and-diversity-of-the-putative-cell-binding-factor-cbf-nmb0345-neis1825-protein-of-neisseria-meningitidis
#17
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
https://www.readbyqxmd.com/read/27468064/a-challenge-in-vaccine-development-neisseria-meningitidis-serogroup-b
#18
EDITORIAL
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
https://www.readbyqxmd.com/read/27468058/immunogenicity-of-a-meningococcal-b-vaccine-during-a-university-outbreak
#19
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
https://www.readbyqxmd.com/read/27467048/characteristics-of-a-new-meningococcal-serogroup-b-vaccine-bivalent-rlp2086-menb-fhbp-trumenba%C3%A2
#20
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
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