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Special Focus Research Paper

A phase 1, randomized, open-label, active-controlled trial to assess the safety of a meningococcal serogroup B bivalent rLP2086 vaccine in healthy adults

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Pages 888-895 | Published online: 01 Jul 2012

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Jamie Findlow, Charles Nuttens & Paula Kriz. (2019) Introduction of a second MenB vaccine into Europe – needs and opportunities for public health. Expert Review of Vaccines 18:3, pages 225-239.
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John L. Perez, Judith Absalon, Johannes Beeslaar, Paul Balmer, Kathrin U. Jansen, Thomas R. Jones, Shannon Harris, Laura J. York, Qin Jiang, David Radley, Annaliesa S. Anderson, Graham Crowther & Joseph J. Eiden. (2018) From research to licensure and beyond: clinical development of MenB-FHbp, a broadly protective meningococcal B vaccine. Expert Review of Vaccines 17:6, pages 461-477.
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Giulia Piccini, Alessandro Torelli, Elena Gianchecchi, Simona Piccirella & Emanuele Montomoli. (2016) Fighting Neisseria meningitidis: past and current vaccination strategies. Expert Review of Vaccines 15:11, pages 1393-1407.
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Kate L Seib, Maria Scarselli, Maurizio Comanducci, Daniela Toneatto & Vega Masignani. (2015) Neisseria meningitidis factor H-binding protein fHbp: a key virulence factor and vaccine antigen. Expert Review of Vaccines 14:6, pages 841-859.
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Nathan James Brendish & Robert Charles Read. (2015) Neisseria meningitidis serogroup B bivalent factor H binding protein vaccine. Expert Review of Vaccines 14:4, pages 493-503.
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Gary W Zlotnick, Thomas R Jones, Paul Liberator, Li Hao, Shannon Harris, Lisa K McNeil, Duzhang Zhu, John Perez, Joseph Eiden, Kathrin U Jansen & Annaliesa S Anderson. (2015) The Discovery and Development of a Novel Vaccine to Protect against Neisseria meningitidis Serogroup B Disease. Human Vaccines & Immunotherapeutics 11:1, pages 5-13.
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Roberto Gasparini, Daniela Amicizia, Alexander Domnich, Piero Luigi Lai & Donatella Panatto. (2014) Neisseria meningitidis B vaccines: recent advances and possible immunization policies. Expert Review of Vaccines 13:3, pages 345-364.
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Julie A Bettinger, Shelley L Deeks, Scott A Halperin, Raymond Tsang & David W Scheifele. (2013) Controlling serogroup B invasive meningococcal disease: the Canadian perspective. Expert Review of Vaccines 12:5, pages 505-517.
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Articles from other publishers (21)

George Kassianos, Osamah Barasheed, Victoria Abbing-Karahagopian, Mansour Khalaf, Serdar Ozturk, Angelika Banzhoff & Selim Badur. (2023) Meningococcal B Immunisation in Adults and Potential Broader Immunisation Strategies: A Narrative Review. Infectious Diseases and Therapy 12:9, pages 2193-2219.
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Johannes Beeslaar, Susan Mather, Judith Absalon, Joseph J. Eiden, Laura J. York, Graham Crowther, Roger Maansson, Jason D. Maguire, Paula Peyrani & John L. Perez. (2022) Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. Vaccine 40:12, pages 1872-1878.
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Sebastian Aston-Deaville, Emil Carlsson, Muhammad Saleem, Angela Thistlethwaite, Hannah Chan, Sunil Maharjan, Alessandra Facchetti, Ian M. Feavers, C. Alistair Siebert, Richard F. Collins, Alan Roseman & Jeremy P. Derrick. (2020) An assessment of the use of Hepatitis B Virus core protein virus-like particles to display heterologous antigens from Neisseria meningitidis. Vaccine 38:16, pages 3201-3209.
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Abigail L. Coughtrie, Johanna M. Jefferies, David W. Cleary, C. Patrick Doncaster, Saul N. Faust, Alex R. Kraaijeveld, Michael V. Moore, Mark A. Mullee, Paul J. Roderick, Jeremy S. Webb, Ho Ming Yuen & Stuart C. Clarke. (2019) Microbial epidemiology and carriage studies for the evaluation of vaccines. Journal of Medical Microbiology 68:10, pages 1408-1418.
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Bingqing Zhu, Fenglin Shi, Aiyu Zhang, Xiaofang Sun, Zheng Xu, Li Xu, Yuan Gao, Jing Lv & Zhujun Shao. (2018) Prevalence and genetic characteristics of 4CMenB and rLP2086 vaccine candidates among Neisseria meningitidis serogroup B strains, China. Vaccine 36:15, pages 1983-1989.
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Matt Shirley & Muhamed-Kheir Taha. (2018) MenB-FHbp Meningococcal Group B Vaccine (Trumenba®): A Review in Active Immunization in Individuals Aged ≥ 10 Years. Drugs 78:2, pages 257-268.
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Theresa M. Fiorito, Grayson L. Baird, Nicole Alexander-Scott, Suzanne Bornschein, Catherine Kelleher, Nan Du & Penelope H. Dennehy. (2018) Adverse Events Following Vaccination With Bivalent rLP2086 (Trumenba®): An Observational, Longitudinal Study During a College Outbreak and a Systematic Review. Pediatric Infectious Disease Journal 37:1, pages e13-e19.
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Lars OstergaardTimo VesikariJudith AbsalonJohannes BeeslaarBrian J. WardShelly SendersJoseph J. EidenKathrin U. JansenAnnaliesa S. AndersonLaura J. YorkThomas R. JonesShannon L. HarrisRobert O’NeillDavid RadleyRoger MaanssonJean-Louis PrégaldienJohn GinisNina B. StaerkeJohn L. Perez. (2017) A Bivalent Meningococcal B Vaccine in Adolescents and Young Adults. New England Journal of Medicine 377:24, pages 2349-2362.
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Karen V. Lithgow, Rebecca Hof, Charmaine Wetherell, Drew Phillips, Simon Houston & Caroline E. Cameron. (2017) A defined syphilis vaccine candidate inhibits dissemination of Treponema pallidum subspecies pallidum. Nature Communications 8:1.
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Carrie L. Byington, Yvonne A. Maldonado, Elizabeth D. Barnett, H. Dele Davies, Kathryn M. Edwards, Ruth Lynfield, Flor M. Munoz, Dawn L. Nolt, Ann-Christine Nyquist, Mobeen H. Rathore, Mark H. Sawyer, William J. Steinbach, Tina Q. Tan & Theoklis E. Zaoutis. (2016) Recommendations for Serogroup B Meningococcal Vaccine for Persons 10 Years and Older. Pediatrics 138:3.
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Vincent Muturi-Kioi, David Lewis, Odile Launay, Geert Leroux-Roels, Alessandra Anemona, Pierre Loulergue, Caroline L. Bodinham, Annelies Aerssens, Nicola Groth, Allan Saul & Audino Podda. (2016) Neutropenia as an Adverse Event following Vaccination: Results from Randomized Clinical Trials in Healthy Adults and Systematic Review. PLOS ONE 11:8, pages e0157385.
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Timo Vesikari, Lars Østergaard, Javier Diez-Domingo, Jacek Wysocki, Carl-Erik Flodmark, Johannes Beeslaar, Joseph Eiden, Qin Jiang, Kathrin U. Jansen, Thomas R. Jones, Shannon L. Harris, Robert E. O'Neill, Laura J. York, Graham Crowther & John L. Perez. (2016) Meningococcal Serogroup B Bivalent rLP2086 Vaccine Elicits Broad and Robust Serum Bactericidal Responses in Healthy Adolescents. Journal of the Pediatric Infectious Diseases Society 5:2, pages 152-160.
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Lars Ostergaard, Gregg H. Lucksinger, Judith Absalon, Johannes Beeslaar, Joseph Eiden, Kathrin U. Jansen, Laura J. York, Angela Quinn, Mette E. Graversen & John L. Perez. (2016) A phase 3, randomized, active-controlled study to assess the safety and tolerability of meningococcal serogroup B vaccine bivalent rLP2086 in healthy adolescents and young adults. Vaccine 34:12, pages 1465-1471.
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Matt Shirley & Sohita Dhillon. (2015) Bivalent rLP2086 Vaccine (Trumenba®): A Review in Active Immunization Against Invasive Meningococcal Group B Disease in Individuals Aged 10–25 Years. BioDrugs 29:5, pages 353-361.
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Federico Martinon-Torres, Francisco Gimenez-Sanchez, Enrique Bernaola-Iturbe, Javier Diez-Domingo, Qin Jiang & John L. Perez. (2014) A randomized, phase 1/2 trial of the safety, tolerability, and immunogenicity of bivalent rLP2086 meningococcal B vaccine in healthy infants. Vaccine 32:40, pages 5206-5211.
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Markus Knuf. (2014) Weitreichende Möglichkeiten der Impfprävention. Pädiatrie 26:S1, pages 20-27.
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Agnese Faleri, Laura Santini, Sébastien Brier, Werner Pansegrau, Paola Lo Surdo, Maria Scarselli, Francesca Buricchi, Gianfranco Volpini, Alessia Genovese, Stijn Veen, Susan Lea, Christoph M. Tang, Silvana Savino, Mariagrazia Pizza, Oretta Finco, Nathalie Norais & Vega Masignani. (2013) Two cross‐reactive monoclonal antibodies recognize overlapping epitopes on Neisseria meningitidis factor H binding protein but have different functional properties . The FASEB Journal 28:4, pages 1644-1653.
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Susan K. Hoiseth, Ellen Murphy, Lubomira Andrew, Ulrich Vogel, Matthias Frosch, Wiebke Hellenbrand, Raquel Abad, Julio A. Vazquez, Ray Borrow, Jamie Findlow, Muhamed-Kheir Taha, Ala-Eddine Deghmane, Dominique A. Caugant, Paula Kriz, Martin Musilek, Leonard W. Mayer, Xin Wang, Jessica R. MacNeil, Laura York, Charles Y. Tan, Kathrin U. Jansen & Annaliesa S. Anderson. (2013) A Multi-country Evaluation of Neisseria meningitidis Serogroup B Factor H–Binding Proteins and Implications for Vaccine Coverage in Different Age Groups. Pediatric Infectious Disease Journal 32:10, pages 1096-1101.
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Lisa K. McNeil, Robert J. Zagursky, Shuo L. Lin, Ellen Murphy, Gary W. Zlotnick, Susan K. Hoiseth, Kathrin U. Jansen & Annaliesa S. Anderson. (2013) Role of Factor H Binding Protein in Neisseria meningitidis Virulence and Its Potential as a Vaccine Candidate To Broadly Protect against Meningococcal Disease. Microbiology and Molecular Biology Reviews 77:2, pages 234-252.
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Michael D. Nissen, Helen S. Marshall, Peter C. Richmond, Qin Jiang, Shannon L. Harris, Thomas R. Jones, Kathrin U. Jansen & John L. Perez. (2013) A Randomized, Controlled, Phase 1/2 Trial of a Neisseria meningitidis Serogroup B Bivalent rLP2086 Vaccine in Healthy Children and Adolescents. Pediatric Infectious Disease Journal 32:4, pages 364-371.
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Helen S. Marshall, Peter C. Richmond, Michael D. Nissen, Ann Wouters, James Baber, Qin Jiang, Annaliesa S. Anderson, Thomas R. Jones, Shannon L. Harris, Kathrin U. Jansen & John L. Perez. (2013) A phase 2 open-label safety and immunogenicity study of a meningococcal B bivalent rLP2086 vaccine in healthy adults. Vaccine 31:12, pages 1569-1575.
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