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4CMenB Breadth of Immune Response, Immunogenicity, and Safety: Results From a Phase 3 Randomized, Controlled, Observer Blind Study in Adolescents and Young Adults
T. Nolan, C. Bhusal, J. Beran, M. Bloch, BS. Cetin, EC. Dinleyici, D. Dražan, S. Kokko, S. Koski, O. Laajalahti, JM. Langley, M. Rämet, PC. Richmond, P. Silas, B. Tapiero, F. Tiong, M. Tipton, B. Ukkonen, B. Ulukol, M. Lattanzi, M. Trapani, A....
Status neindexováno Jazyk angličtina Země Spojené státy americké
Typ dokumentu klinické zkoušky, časopisecké články
NLK
Directory of Open Access Journals
od 2014
Free Medical Journals
od 2014
PubMed Central
od 2014
Europe PubMed Central
od 2014
Open Access Digital Library
od 2014-01-01
Open Access Digital Library
od 2014-01-01
Open Access Digital Library
od 2014-01-01
Oxford Journals Open Access Collection
od 2014
ROAD: Directory of Open Access Scholarly Resources
od 2014
PubMed
39582508
DOI
10.1093/ofid/ofae638
Knihovny.cz E-zdroje
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
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.
AusTrials Tarragindi QLD Australia
Canadian Center for Vaccinology Halifax NS Canada
CHU Sainte Justine Montreal QC Canada
Copperview Medical Center South Jordan Utah USA
Department of Medicine Kirby Institute University of New South Wales Sydney NSW Australia
Department of Pediatric Infectious Diseases Erciyes University Faculty of Medicine Kayseri Türkiye
Department of Pediatrics Ankara University School of Medicine Ankara Türkiye
Eskisehir Osmangazi University Faculty of Medicine Eskisehir Türkiye
FVR Finnish Vaccine Research and Tampere University Espoo Clinic Espoo Finland
General Practice for Children and Adolescents Jindřichův Hradec Czechia
Helsinki South Clinic FVR Finnish Vaccine Research and Tampere University Finland
Holdsworth House Medical Practice Sydney NSW Australia
Infectious Diseases Division Department of Pediatrics University of Montreal QC Canada
Oulu Vaccine Research Clinic FVR Finnish Vaccine Research and Tampere University Oulu Finland
Vaccination and Travel Medicine Centre Hradec Králové Czechia
Citace poskytuje Crossref.org
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