Safety, immunogenicity, and tolerability of meningococcal serogroup B bivalent recombinant lipoprotein 2086 vaccine in healthy adolescents: a randomised, single-blind, placebo-controlled, phase 2 trial

The Lancet Infectious Diseases
P C Richmond2001 Study Investigators

Abstract

Neisseria meningitidis serogroup B is a major cause of invasive meningococcal disease, but a broadly protective vaccine is not currently licensed. A bivalent recombinant factor H-binding protein vaccine (recombinant lipoprotein 2086) has been developed to provide broad coverage against diverse invasive meningococcus serogroup B strains. Our aim was to test the immune response of this vaccine. This randomised, placebo-controlled trial enrolled healthy adolescents from 25 sites in Australia, Poland, and Spain. Exclusion criteria were previous invasive meningococcal disease or serogroup B vaccination, previous adverse reaction or known hypersensitivity to the vaccine, any significant comorbidities, and immunosuppressive therapy or receipt of blood products in the past 6 months. Participants were randomly assigned with a computerised block randomisation scheme to receive ascending doses of vaccine (60, 120, or 200 μg) or placebo at 0, 2, and 6 months. Principal investigators, participants and their guardians, and laboratory personnel were masked to the allocation; dispensing staff were not. Immunogenicity was measured by serum bactericidal assays using human complement (hSBA) against eight diverse meningococcus serogroup B strains....Continue Reading

References

Jun 1, 1969·The Journal of Experimental Medicine·I GoldschneiderM S Artenstein
May 9, 2000·Clinical and Diagnostic Laboratory Immunology·J JelfsD A Caugant
Mar 19, 2003·The Journal of Experimental Medicine·Vega MasignaniMariagrazia Pizza
Mar 25, 2004·Infection and Immunity·Leah D FletcherGary W Zlotnick
Feb 7, 2006·Lancet·Matthew J ThompsonMichael Levin
Apr 20, 2006·Vaccine·Marc P GirardMarie Paule Kieny
May 30, 2009·Vaccine·David PaceNancy E Messonier
Aug 10, 2010·Nature Genetics·Sonia DavilaUNKNOWN International Meningococcal Genetics Consortium
Nov 16, 2010·The Lancet Infectious Diseases·Hannah ChristensenCaroline L Trotter
Mar 22, 2013·MMWR. Recommendations and Reports : Morbidity and Mortality Weekly Report. Recommendations and Reports·Amanda C CohnUNKNOWN Centers for Disease Control and Prevention (CDC)

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Citations

Oct 22, 2013·The Journal of Infection·Marion Roderick, Adam Finn
Oct 17, 2012·Clinical Epidemiology·Qiuzhi ChangDavid S Stephens
Jan 15, 2014·Anales de pediatría : publicación oficial de la Asociación Española de Pediatría (A.E.P.)·D Moreno-PérezUNKNOWN Comité Asesor de Vacunas de la Asociación Española de Pediatría
Feb 24, 2015·Expert Review of Vaccines·Kate L SeibVega Masignani
Dec 9, 2014·Expert Opinion on Biological Therapy·Christine S RollierAndrew J Pollard
Dec 17, 2014·BMC Infectious Diseases·Peter BoanAnthony D Keil
Jul 9, 2013·Critical Care Clinics·Paul A CampsallDaniel J Niven
Dec 12, 2012·Anales de pediatría : publicación oficial de la Asociación Española de Pediatría (A.E.P.)·D Moreno-PérezUNKNOWN Comité Asesor de Vacunas de la Asociación Española de Pediatría, España
Dec 15, 2015·Expert Review of Vaccines·Volker VetterRay Borrow
Sep 24, 2015·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Matt Shirley, Sohita Dhillon
Jun 4, 2015·Human Vaccines & Immunotherapeutics·Michael BrökerGeorgina Tzanakaki
Jan 31, 2014·Expert Review of Vaccines·Roberto GaspariniDonatella Panatto
Sep 26, 2015·Journal of the Pediatric Infectious Diseases Society·Timo VesikariJohn L Perez
Feb 19, 2013·Microbial Pathogenesis·Nicole M CaesarXin Fan
Dec 20, 2012·Human Vaccines & Immunotherapeutics·Annaliesa S AndersonKathrin U Jansen
Oct 4, 2012·Human Vaccines & Immunotherapeutics·Michael BrökerGeorgina Tzanakaki
Feb 15, 2013·Human Vaccines & Immunotherapeutics·Koen B PouwelsMaarten J Postma
Dec 9, 2014·Human Vaccines & Immunotherapeutics·Gary W ZlotnickAnnaliesa S Anderson
Dec 3, 2014·Current Opinion in Microbiology·Mariagrazia Pizza, Rino Rappuoli
Oct 18, 2016·The Lancet Infectious Diseases·David S Stephens
May 10, 2016·Expert Review of Vaccines·Giulia PicciniEmanuele Montomoli
Dec 15, 2016·Human Vaccines & Immunotherapeutics·Robert G K DonaldAnnaliesa S Anderson

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