A comparative evaluation of two investigational meningococcal ABCWY vaccine formulations: Results of a phase 2 randomized, controlled trial

Vaccine
Stan L BlockIgor Smolenov

Abstract

A meningococcal vaccine protective against all major disease-associated serogroups (A, B, C, W and Y) is an unmet public health need. In this phase 2 observer-blinded, randomized, controlled study, two investigational meningococcal ABCWY vaccine formulations were evaluated to assess their immunological noninferiority to a licensed quadrivalent meningococcal ACWY glycoconjugate vaccine (MenACWY-CRM) for serogroups ACWY and immunogenicity against serogroup B test strains, as well as for formulation selection based on a desirability index (DI). Each investigational MenABCWY formulation contained recombinant protein and outer membrane vesicle (OMV) components of a licensed serogroup B vaccine (4CMenB) combined with components of MenACWY-CRM. A total of 484 healthy 10-25 year-old participants were randomized to receive two doses, two months apart, of an investigational MenABCWY formulation that contained either a full or one-quarter dose of OMV, 4CMenB alone, or a Placebo followed by MenACWY-CRM. Immunogenicity against each of serogroups ACWY and four serogroup B test strains was assessed by serum bactericidal assay with human complement (hSBA). MenABCWY formulations were compared by a DI based on key immunogenicity and reactogenici...Continue Reading

References

Nov 1, 1972·The Journal of Infectious Diseases·F A WyleJ P Lowenthal
Dec 26, 2001·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·L K BallT M Finn
May 19, 2006·Emerging Infectious Diseases·Jenny MacLennanUNKNOWN United Kingdom Meningococcal Carriage Group
Jul 11, 2006·Proceedings of the National Academy of Sciences of the United States of America·Marzia M GiulianiMariagrazia Pizza
Sep 23, 2006·Expert Review of Vaccines·Harry L KeyserlingGregory P Gilmet
May 30, 2009·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Lisa A JacksonUNKNOWN V59P13 Study Group
May 30, 2009·Vaccine·Lee H HarrisonMary E Ramsay
Dec 17, 2009·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Amanda C CohnNancy E Messonnier
Sep 17, 2010·The Pediatric Infectious Disease Journal·Matthew D SnapeAndrew J Pollard
Oct 22, 2010·Proceedings of the National Academy of Sciences of the United States of America·John DonnellyMarzia Monica Giuliani
Dec 20, 2011·Vaccine·Scott A HalperinMarco A P Sáfadi
May 25, 2012·Vaccine·David Pace, Andrew J Pollard
Jul 24, 2012·The Lancet Infectious Diseases·Ryan T NovakThomas A Clark
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)
Apr 19, 2013·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Sema MandalAmanda C Cohn
Jan 31, 2014·Expert Review of Vaccines·Roberto GaspariniDonatella Panatto
Nov 27, 2014·Human Vaccines & Immunotherapeutics·Susanna EspositoDaniela Toneatto
Apr 3, 2016·The Lancet Infectious Diseases·Stephen K Obaro, Abdulrazaq G Habib

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Citations

Aug 22, 2015·Expert Review of Anti-infective Therapy·Roland NauHelmut Eiffert
Nov 23, 2015·American Journal of Preventive Medicine·Lee H Harrison
Jun 4, 2016·Current Opinion in Infectious Diseases·Esther Benamu, José G Montoya
Jul 28, 2016·The Journal of Adolescent Health : Official Publication of the Society for Adolescent Medicine·Carol J Baker
May 10, 2016·Expert Review of Vaccines·Giulia PicciniEmanuele Montomoli
Apr 1, 2017·Journal of American College Health : J of ACH·Jonathan DuffyManisha Patel
Apr 5, 2017·Expert Review of Vaccines·Daniela ToneattoRino Rappuoli
Apr 2, 2019·Human Vaccines & Immunotherapeutics·Angee McDanielAmit Srivastava
Apr 7, 2020·Expert Review of Vaccines·Federico Martinón-TorresMarco Aurelio P Safadi
Oct 8, 2020·Microorganisms·Mariagrazia PizzaRino Rappuoli
Jan 9, 2021·MMWR. Recommendations and Reports : Morbidity and Mortality Weekly Report. Recommendations and Reports·Sarah A MbaeyiJessica R MacNeil
May 3, 2021·The Journal of Infection·Federico Martinón-TorresRafik Bekkat-Berkani
Sep 28, 2021·Pathogens and Global Health·Federico Martinón-TorresVéronique Abitbol

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