Maqola

4CMenB Breadth of Immune Response, Immunogenicity, and Safety: Results From a Phase 3 Randomized, Controlled, Observer Blind Study in Adolescents and Young Adults

Terry NolanVaccine and Immunisation Research Group, Peter Doherty Institute at the University of Melbourne, and Murdoch Children's Research Institute, Melbourne, Victoria, AustraliaChiranjiwi BhusalJiřı́ BeranMark BlochDepartment of Medicine, Kirby Institute, University of New South Wales , Sydney, NSW ,Benhur Şirvan ÇetinDepartment of Pediatric Infectious Diseases, Erciyes University Faculty of Medicine , Kayseri, TürkiyeEner Çağrı DinleyiciEskisehir Osmangazi University Faculty of Medicine , Eskisehir, TürkiyeDaniel DražanGeneral Practice for Children and Adolescents , Jindřichův Hradec ,Satu KokkoOulu Vaccine Research Clinic, FVR Finnish Vaccine Research and Tampere University , Oulu ,Susanna KoskiHelsinki South Clinic, FVR Finnish Vaccine Research and Tampere University ,Outi LaajalahtiFVR Finnish Vaccine Research and Tampere University, Seinäjoen Rokotetutkimusklinikka , Seinäjoki ,Joanne Marie LangleyCanadian Center for Vaccinology (Dalhousie University, IWK Health and Nova Scotia Health) , Halifax, NS ,Mika RämetFaculty of Medicine and Health Technology, FVR Finnish Vaccine Research, Tampere University , Tampere ,Peter RichmondUniversity of Western Australia School of Medicine and Vaccine Trials Group, Telethon Kids Institute, Nedlands, WA, AustraliaPeter E. SilasBruce TapiéroCHU Sainte-Justine , Montreal, QC ,Florence TiongAusTrials (Wellers Hill), Tarragindi, QLD, AustraliaMary TiptonBenita UkkonenFVR Finnish Vaccine Research and Tampere University, Espoo Clinic , Espoo ,Betül UlukolDepartment of Pediatrics, Ankara University School of Medicine , Ankara, TürkiyeMaria LattanziGSK , Siena ,Mauro TrapaniGSK , Siena ,Arnold WillemsenDaniela ToneattoGSK , Siena ,the QUINTET study groupRonald T. AckermanRenata AdamovskaEugene AthanKwabena AyesuDavid BernardChiranjiwi BhusalMark BlochHoldsworth House Medical PracticeWilliam ByarsRobert CarterMaia ChakerianMarije DaleboutFerdinandus de LoozeMarc DionneDaniel DražanGeneral Practice for Children and Adolescents , Jindřichův Hradec ,Peter DzongowskiRand S. FarjoDaniel FinnGeorge FreemanRyan C GottfredsonPaul GrubbAnil Kumar GuptaTolga İ̇nceRobert J. JeanfreauJake D. JonesJames D. KellnerKaia KiirojaSatu KokkoOulu Vaccine Research Clinic, FVR Finnish Vaccine Research and Tampere University , Oulu ,Outi LaajalahtiFVR Finnish Vaccine Research and Tampere University, Seinäjoen Rokotetutkimusklinikka , Seinäjoki ,Isabelle LechevinHemalini MehtaSandra MeisaluDanielle MorelleTerry NolanVaccine and Immunisation Research Group, Peter Doherty Institute at the University of Melbourne, and Murdoch Children's Research Institute , Melbourne, Victoria ,Alexander OsowaPauliina PaavolaMinesh PatelMiroslav PavlasekEnrique PelayoMika RämetFaculty of Medicine and Health Technology, FVR Finnish Vaccine Research, Tampere University , Tampere ,Stéfanie RaulierPeter RichmondUniversity of Western Australia School of Medicine and Vaccine Trials Group, Telethon Kids Institute , Nedlands, Washington ,Walter RokRambod RouhbakhshManish SadaranganiYamirka SanchezMartin SchearJohn ScottIlkka SeppäPeter SilasWilliam SimonMartina SpaziererovaJonathan StabenJoseph SurberBruce TapiéroInfectious Diseases Division, Department of Pediatrics, University of Montreal , QC ,Florence TiongKokand State UniversityMary TiptonMauro TrapaniBenita UkkonenFVR Finnish Vaccine Research and Tampere University, Espoo Clinic , Espoo ,Marie-Louise VachonNoah ValeDominique WautersJosef Zemanek

2024en

Ochiq kirishOltin

Litsenziya: cc-by

ABI

Annotatsiya

Background: Meningococcal serogroup B (MenB) strains are highly diverse. Breadth of immune response for the MenB vaccine, 4CMenB, administered at 0-2, 0-6, or 0-2-6 months, was demonstrated by endogenous complement-human serum bactericidal antibody (enc-hSBA) assay against an epidemiologically relevant panel of 110 MenB strains. Methods: In a phase 3 trial, 3651 healthy 10- to 25-year-old participants were randomized 5:5:9:1 to receive 4CMenB (0-6 schedule), 4CMenB (0-2-6 schedule), investigational MenABCWY vaccine, or control MenACWY-CRM vaccine. The primary objectives were to evaluate safety and demonstrate breadth of immune response by enc-hSBA assay against the MenB strain panel using test-based (percentage of samples without bactericidal activity against strains after 4CMenB vs control vaccination) and responder-based (percentage of participants whose postvaccination sera kill ≥70% strains) approaches. Success was demonstrated with 2-sided 97.5% confidence interval (CI) lower limit >65%. Immunogenicity was assessed by traditional hSBA assay against four indicator strains. Results: Breadth of immune response (test-based) was 78.7% (97.5% CI, 77.2-80.1), 81.8% (80.4-83.1), 83.2% (81.9-84.4) for the 0-2, 0-6, and 0-2-6 schedules, respectively, and (responder-based) 84.8% (81.8-87.5), 89.8% (87.2-92.0), and 93.4% (91.2-95.2), respectively. No clinically relevant differences in immunogenicity were observed across schedules. 4CMenB was well tolerated. Conclusions: The 2-dose (0-2, 0-6) 4CMenB schedules met predefined criteria for success for both breadth of immune response endpoints against a diverse MenB strain panel, had comparable immunogenicity, and safety in line with the established 4CMenB safety profile. The 3-dose schedule provided no additional immunological benefit, supporting use of the 4CMenB 0-2 schedule.

Hali tarjima qilinmagan

Identifikatorlar

DOI: 10.1093/ofid/ofae638

Iqtiboslar va manbalar

0 ta iqtibos43 ta foydalanilgan manba