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Khurram Sunasara, John Cundy, Sriram Srinivasan, Brad Evans, Weiqiang Sun, Scott Cook, Eric Bortell, John Farley, Daniel Griffin, Michele Bailey Piatchek, Katherine Arch-Douglas
The phrase "Process is the Product" is often applied to biologics, including multicomponent vaccines composed of complex components that evade complete characterization. Vaccine production processes must be defined and locked early in the development cycle to ensure consistent quality of the vaccine throughout scale-up, clinical studies, and commercialization. This approach of front-loading the development work helped facilitate the accelerated approval of the Biologic License Application for the well-characterized vaccine bivalent rLP2086 (Trumenba®, Pfizer Inc) in 2014 under Breakthrough Therapy Designation...
April 19, 2017: Vaccine
Heidi M Soeters, Jill Dinitz-Sklar, Prathit A Kulkarni, Jessica R MacNeil, Lucy A McNamara, Elizabeth Zaremski, How-Yi Chang, Eduardo Lujan, Dan Granoff, Melodee Lasky, Barbara Montana
In response to a university-based serogroup B meningococcal disease outbreak, the serogroup B meningococcal vaccine Trumenba was recommended for students, a rare instance in which a specific vaccine brand was recommended. This outbreak highlights the challenges of using molecular and immunologic data to inform real-time response.
May 2017: Emerging Infectious Diseases
Maria Serena Gallone, Carmen Martino, Michele Quarto, Silvio Tafuri
In 2014, an Italian hospital implemented a protocol for pneumococcal, meningococcal, and Haemophilus influenzae type b vaccines offer to splenectomized patients during their hospitalization. After 1 year, coverage for recommended vaccinations increased from 5.7%-66.7% and the average time between splenectomy and vaccines administration decreased from 84.7-7.5 days.
April 11, 2017: American Journal of Infection Control
Helen Campbell, Michael Edelstein, Nick Andrews, Ray Borrow, Mary Ramsay, Shamez Ladhani
During the first 12 months of an emergency meningococcal ACWY vaccination program for teenagers in England, coverage among persons who left school in 2015, the first cohort to be vaccinated, was 36.6%. There were 69% fewer group W meningococcal cases than predicted by trend analysis and no cases in vaccinated teenagers.
July 15, 2017: Emerging Infectious Diseases
Nicola J Beresford, Angela Martino, Ian M Feavers, Michael J Corbel, Xilian Bai, Ray Borrow, Barbara Bolgiano
A physicochemical and immunological study of the stability of three different meningococcal (Men) ACWY conjugate vaccines was performed to evaluate any patterns of serogroup oligo- or polysaccharide-specific or carrier protein-specific stability that would affect immunogenicity. Critical quality and stability-indicating characteristics were measured, with the study supporting the suitability of both HPLC-SEC and HPAEC-PAD methods to detect changes following inappropriate vaccine storage. All three final products, ACWY-CRM197, -DT and -TT conjugate vaccines had expected quality indicator values and similar immunogenicity in a mouse model (anti-PS IgG and rSBA) when stored at +2-8°C...
April 10, 2017: Vaccine
Joy Seanehia, Carole Treibich, Christine Holmberg, Jacqueline Müller-Nordhorn, Valerie Casin, Jocelyn Raude, Judith E Mueller
BACKGROUND: Several concepts are available to explain vaccine decision making by individual and inter-individual factors, including risk perception, social conformism and altruism. However, only a few studies have quantified the weight of these determinants in vaccine acceptance. Using a conjoint analysis tool, we aimed at eliciting preferences in a student population regarding vaccination against a rare, severe and rapidly evolving hypothetical disease, similar to meningococcal serogroup C meningitis or measles...
April 10, 2017: Vaccine
Susu M Zughaier
The protective effect of meningococcal vaccines targeting disease causing serogroups exemplified by the introduction of MenAfriVac™ in Africa, is well established and documented in large population-based studies. Due to the emergence of other meningococcal disease causing serogroups, novel vaccine formulations are needed. There is a high potential for novel nanotechnology-based meningococcal vaccine formulations that can provide wider vaccine coverage. The proposed meningococcal vaccine formulation contains spherical shaped micro and nanoparticles that are biological mimics of Niesseria meningitidis, therefore present to immune system as invader and elicit robust immune responses...
April 10, 2017: Human Vaccines & Immunotherapeutics
Christelle Xian-Ting Tan, Yang Chern Lim
We describe a rare case of infantile meningococcal (serotype B) meningitis in a 3-month-old Chinese boy with an atypical indolent presentation with prolonged persistent fever despite appropriate antimicrobial therapy likely due to drug fever. The case highlights the need for continued vigilance in identifying similar cases in the future.
April 7, 2017: BMJ Case Reports
Caroline Vipond, Carolyn J Swann, Thomas W Dougall, Peter Rigsby, Fang Gao, Nicola J Beresford, Barbara Bolgiano
Polysaccharide (PS) based meningococcal vaccines are primarily evaluated by physicochemical methods to ensure batches are consistently manufactured. As PS content is determined by different methods across numerous laboratories, there is a need for International Standards (IS) to calibrate the assays. Following the successful introduction of the WHO Meningococcal group C (MenC) IS in 2011, NIBSC initiated projects to prepare similar standards for groups A, W, Y and X (MenA/W/Y/X) to standardise all meningococcal- PS based vaccines...
April 4, 2017: Biologicals: Journal of the International Association of Biological Standardization
Biju Joseph Ampattu, Laura Hagmann, Chunguang Liang, Marcus Dittrich, Andreas Schlüter, Jochen Blom, Elizaveta Krol, Alexander Goesmann, Anke Becker, Thomas Dandekar, Tobias Müller, Christoph Schoen
BACKGROUND: Commensal bacteria like Neisseria meningitidis sometimes cause serious disease. However, genomic comparison of hyperinvasive and apathogenic lineages did not reveal unambiguous hints towards indispensable virulence factors. Here, in a systems biological approach we compared gene expression of the invasive strain MC58 and the carriage strain α522 under different ex vivo conditions mimicking commensal and virulence compartments to assess the strain-specific impact of gene regulation on meningococcal virulence...
April 7, 2017: BMC Genomics
Sara Sigurlásdóttir, Jakob Engman, Olaspers Sara Eriksson, Sunil D Saroj, Nadezda Zguna, Pilar Lloris-Garcerá, Leopold L Ilag, Ann-Beth Jonsson
The development of meningococcal disease, caused by the human pathogen Neisseria meningitidis, is preceded by the colonization of the epithelial layer in the nasopharynx. After initial adhesion to host cells meningococci form aggregates, through pilus-pilus interactions, termed microcolonies from which the bacteria later detach. Dispersal from microcolonies enables access to new colonization sites and facilitates the crossing of the cell barrier; however, this process is poorly understood. In this study, we used live-cell imaging to investigate the process of N...
April 2017: PLoS Pathogens
Jesús Pérez-Ortega, Antonio Rodríguez, Eduardo Ribes, Jan Tommassen, Jesús Arenas
Neisseria meningitidis (Nm) and Neisseria lactamica (Nl) are commensal bacteria that live in the human nasopharynx, where they form microcolonies. In contrast to Nl, Nm occasionally causes blood and/or meningitis infection with often fatal consequences. Here, we studied interactions between neisserial strains during biofilm formation. Fluorescent strains were engineered and analyzed for growth in single- and dual-strain biofilms with confocal laser-scanning microscopy. Different strains of diverse Neisseria species formed microcolonies of different sizes and morphologies...
2017: Frontiers in Microbiology
Julia Dick, Sabrina Hebling, Jérôme Becam, Muhamed-Kheir Taha, Alexandra Schubert-Unkmeir
The interaction of Neisseria meningitidis with both peripheral and brain endothelial cells is a critical event in the development of invasive meningococcal disease. In this study, we used in vitro models based on human brain microvascular endothelial cells (HBMEC), and peripheral endothelial EA.hy926 cells, to investigate their roles in the inflammatory response towards meningococcal infection. Both cell lines were infected with two pathogenic N. meningitidis isolates and secretion of the cytokine interleukin-6 (IL-6), the CXC chemokine IL-8 and the monocyte chemoattractant protein-1 (MCP-1) were estimated by ELISA...
April 1, 2017: Pathogens and Disease
Carlos Espinosa-Viñals, Dagmar García-Rivera, Laura Rodríguez Noda, Aylín Amador Gómez, Milagros Nicot, Orialys Valle, Juan F Núñez, Yanet Martin, Darielys Santana, Yury Valdés, Vicente Vérez Bencomo
Finlay Vaccine Institute is developing a new heptavalent conjugate vaccine against Streptococcus pneumoniae. As infants are the target population, PCV7-TT will be necessarily co-administered with other vaccines, and then, the interactions represent a concern. The aim of this work is to evaluate the possible immunological interferences in rabbits as animal experimental model. Rabbits were immunized with Heberpenta®-L, VA-MENGOC-BC®, and PCV7-TT. Blood samples were taken fourteen days after final immunization for obtaining sera...
April 5, 2017: Immunological Investigations
Mohamed Tashani, Leon Heron, Melanie Wong, Harunor Rashid, Robert Booy
Background: : Due to their antigenic similarities, there is a potential for immunological interaction between tetanus/diphtheria-containing vaccines and carrier proteins presented on conjugate vaccines. The interaction could, unpredictably, result in either enhancement or suppression of the immune response to conjugate vaccines if they are injected soon after or concurrently with diphtheria or tetanus toxoid. We examined this interaction among adult Australian travellers before attending the Hajj pilgrimage of 2015...
July 1, 2017: Journal of Travel Medicine
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...
April 10, 2017: Expert Review of Vaccines
Z Vacková, P Křížová, Z Jandová, M Musílek, J Kozáková
The implementation of the surveillance of invasive meningococcal disease is recommended worldwide. The Whole Genome Sequencing (WGS) method increasingly comes to the fore, which provides the possibilities for further detailed characterization of Neisseria meningitidis and makes it possible to integrate all conventional sequencing approaches into one method. Six N. meningitidis isolates from 2013 and 2015, characterized previously by Sanger amplicon sequencing, were selected to be studied by the novel WGS method...
2017: Epidemiologie, Mikrobiologie, Imunologie
Yih-Ling Tzeng, Jose A Bazan, Abigail Norris Turner, Xin Wang, Adam C Retchless, Timothy D Read, Evelyn Toh, David E Nelson, Carlos Del Rio, David S Stephens
Neisseria meningitidis (Nm) clonal complex 11 (cc11) lineage is a hypervirulent pathogen responsible for outbreaks of invasive meningococcal disease, including among men who have sex with men, and is increasingly associated with urogenital infections. Recently, clusters of Nm urethritis have emerged primarily among heterosexual males in the United States. We determined that nonencapsulated meningococcal isolates from an ongoing Nm urethritis outbreak among epidemiologically unrelated men in Columbus, Ohio, are linked to increased Nm urethritis cases in multiple US cities, including Atlanta and Indianapolis, and that they form a unique clade (the US Nm urethritis clade, US_NmUC)...
April 3, 2017: Proceedings of the National Academy of Sciences of the United States of America
C Franco-Jarava, D Comas, A Orren, M Hernández-González, R Colobran
Complement C5 deficiency (C5D) is a rare primary immunodeficiency associated with recurrent infections, particularly meningitis, by Neisseria species. To date, studies to elucidate the molecular basis of hereditary C5D have included fewer than 40 families, and most C5 mutations (13 of 17) have been found in single families. However, the recently described C5 p.A252T mutation is reported to be associated with approximately 7% of meningococcal disease cases in South Africa. This finding raises the question of whether the mutation may be prevalent in other parts of Africa or other continental regions...
April 1, 2017: Clinical and Experimental Immunology
Manish Sadarangani, Sheula Barlow, Mark Anthony, Andrew J Pollard
No abstract text is available yet for this article.
March 20, 2017: Journal of the Pediatric Infectious Diseases Society
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