Clinical data supporting a 2-dose schedule of MenB-FHbp,a bivalent meningococcal serogroup B vaccine,in adolescents and young adults |
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| Affiliation: | 1. Pfizer Vaccine Clinical Research and Development, Hurley, UK;2. Pfizer Vaccine Clinical Research and Development, Pearl River, NY, USA;3. Pfizer Vaccine Clinical Research and Development, Collegeville, PA, USA;4. Pfizer US Medical Affairs, Collegeville, PA, USA;5. Pfizer Vaccines Medical Development, Scientific & Clinical Affairs, Collegeville, PA, USA;1. National Immunization Program Center, Chinese Center for Disease Control and Prevention, Beijing 10050, PR China;2. National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing 102206, PR China;1. Kentucky Pediatric and Adult Research, Bardstown, KY, USA;2. Department of Pediatric Infectious Diseases, Wroclaw Medical University, Wroclaw, Poland;3. Bluegrass Clinical Research Inc, Louisville, KY, USA;4. Department of Pediatrics, Medical Center of Postgraduate Education, Warsaw, Poland;5. Novartis Pharma BV, Amsterdam, Netherlands;6. Novartis Vaccines and Diagnostics, Inc., Cambridge, MA, USA;1. Novartis Vaccines, Siena, Italy;2. Center for Global Health Cincinnati Children''s Hospital, 3333 Burnett Avenue, Cincinnati, OH 45229, USA;1. Kaiser Permanente Vaccine Study Center, 1 Kaiser Plaza, 16th Floor, Oakland, CA 94612, United States;2. Clinic of Children''s Infectious Diseases, Černopolní 212/9, 662 63 Brno, Czech Republic;3. Department of Infectious Diseases, University Hospital, Charles University in Prague, Sokolska 581, 500 05 Hradec Kralove, Czech Republic;4. Department of Medicine, Duke University School of Medicine, Durham, NC 27703, United States;5. GSK, 5, Embassy Links, SRT Road, Opp to Accenture, Cunningham Road, Vasanth Nagar, Bangalore, Karnataka 560052, India;6. GSK, 14200 Shady Grove Road, Rockville, MD 20850, United States;7. Chiltern International for GSK, Avenue Fleming 20 (W23), 1300 Wavre, Belgium;8. GSK, Avenue Fleming 20 (W23), 1300 Wavre, Belgium;1. Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Johannesburg, South Africa;2. Department of Science and Technology National Research Foundation, Vaccine Preventable Diseases, Johannesburg, South Africa;3. Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa;4. Murdoch Children''s Research Institute and Melbourne School of Population and Global Health, University of Melbourne, Carlton, Victoria 3010, Australia;5. Clinical Trials Research Center, Canadian Center for Vaccinology, Dalhousie University and the IWK Health Centre, 5850/5980 University Avenue, Halifax, NS B3K 6R8, Canada;6. Department of Pediatrics, Ege University Faculty of Medicine, 35100 Bornova, Izmir, Turkey;7. Setshaba Research Centre, 2088 Block H, Soshanguve, Pretoria 0152, South Africa;8. Division of Paediatrics, University of Western Australia and Vaccine Trials Group, Telethon Kids Institute, 100 Roberts Road, Subiaco, WA 6008, Australia;9. Adelaide Medical School and Robinson Research Institute, University of Adelaide and Vaccinology and Immunology Research Trials Unit, Women''s and Children''s Health Network, Adelaide, 72 King William Road, North Adelaide, South Australia 5006, Australia;10. Faculty of Medicine, Hacettepe University, Sihhiye 06100, Ankara, Turkey;11. GSK, 5, Embassy Links, SRT Road, Opp to Accenture, Cunningham Road, Vasanth Nagar, Bangalore, Karnataka 560052, India;13. GSK, Avenue Fleming 20 (W23), 1300 Wavre, Belgium;1. Agence de Médecine Préventive, Ferney-Voltaire, France;2. Faculty of Infectious and Tropical Disease, London School of Hygiene and Tropical Medicine, London, UK;3. Meningitis Research Foundation, Bristol, UK;4. Department of Pediatrics, University of Pennsylvania, Philadelphia, PA, USA;5. Pediatrics Department, Faculdade de Ciências Médicas Santa Casa de São Paulo, São Paulo, Brazil;6. Child Health Research Foundation, Department of Microbiology, Dhaka Shishu Hospital, Dhaka, Bangladesh;7. Institut Pasteur, Invasive Bacterial Infections Unit, Paris, France;8. Department of Microbiology, College of Natural Sciences, Redeemer''s University, Lagos, Nigeria;9. Agence de Médecine Préventive, Paris, France |
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| Abstract: | Invasive meningococcal disease (IMD) caused by Neisseria meningitidis is a potentially devastating condition that can result in death and is associated with serious long-term sequelae in survivors. Vaccination is the preferred preventative strategy. Quadrivalent polysaccharide-based vaccines that protect against infection caused by meningococcal serogroups A, C, W, and Y are not effective against meningococcal serogroup B (MenB), which was responsible for approximately 60% and 35% of confirmed IMD cases in the European Union and the United States in 2016, respectively. A recombinant protein MenB vaccine (MenB-FHbp [bivalent rLP2086; Trumenba®]) has been approved for protection against MenB infection in persons 10–25 years of age in the United States and Canada and for individuals ≥10 years of age in the European Union and Australia. In these regions, MenB-FHbp is approved as a 2- or 3-dose primary vaccination schedule. This report will review the current evidence supporting administration of MenB-FHbp as a 2-dose primary vaccination schedule. Different contexts in which a 2- or 3-dose primary vaccination schedule might be preferred (eg, routine prospective vaccination vs outbreak control) are reviewed. |
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| Keywords: | Bivalent LP2086 vaccine Invasive meningococcal disease Dosing Dose schedules 2-dose schedule MenB-FHbp |
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