| Description | MOREIRA JUNIOR, Edson Duarte. Fundação Oswalado Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil. aVaccine Research Area, FISABIO-Public Health, Valencia, Spain; bInfectious Disease, Hospital General de Durango, Durango, Mexico; cKliiniliste
Uuringute Keskus, Tartu, Estonia; dPediatrics, Faculty of Medicine, Eskisehir Osmangazi University, Eskisehir, Turkey; eTiervlei Trial Centre, Karl Bremer
Hospital, Bellville, South Africa; fInstituto Hispalense de Pediatria, Seville, Spain; gFaculty of Medicine, Dokuz Eylul University, Izmir, Turkey;
hAssociação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Salvador, Brazil; iSetshaba Research Centre, Tshwane,
and Faculty of Health Sciences, Department of Medical Microbiology, University of Pretoria, Pretoria, South Africa; jCentro de Pesquisas Clinicas de
Natal, Rio Grande do Norta, Brazil; kInfectious Diseases and Epidemiology, Siberian State Medical University, Tomsk, Russian Federation; lMedical Care
and Research SA de CV, Mérida, Mexico; mClinical Research and Development Centre, GSK, Siena, Italy; nBiostatistics, GSK, Siena, Italy; oBiostatistics,
GSK, Amsterdam, The Netherlands; pData Strategy & Management, Global Clinical Operations Development – R&D, GSK, Amsterdam, The
Netherlands; qClinical Laboratory Sciences, GSK, Rixensart, Belgium; rTechnical Development, GSK, Siena, Italy; sSafety Evaluation and Risk
Management, GSK, Siena, Italy; tGlobal Clinical Operations, GSK, Bangalore, India; uMedical Department, GSK, Madrid, Spain; vGlobal Clinical Delivery,
Global Clinical Operations Development, GSK, Siena, Italy | pt_BR |
| Abstract | A fully liquid MenACWY-CRM vaccine presentation has been developed, modifying the meningococcal
serogroup A (MenA) component from lyophilized to liquid. The safety and immunogenicity of the liquid
presentation at the end of the intended shelf-life (aged for 24 or 30 months) were compared to the
licensed lyophilized/liquid presentation. This multicenter, randomized (1:1), observer-blind, phase 2b
study (NCT03433482) enrolled adolescents and young adults (age 10–40 years). In part 1, 844 participants
received one dose of liquid presentation stored for approximately 24 months or licensed presentation. In
part 2, 846 participants received one dose of liquid presentation stored for approximately 30 months or
licensed presentation. After storage, the MenA free saccharide (FS) level was approximately 25% and
O-acetylation was approximately 45%. The primary objective was to demonstrate non-inferiority of the
liquid presentation to licensed presentation, as measured by human serum bactericidal assay (hSBA)
geometric mean titers (GMTs) against MenA, 1-month post-vaccination. Immune responses against each
vaccine serogroup were similar between groups. Between-group ratios of hSBA GMTs for MenA were 1.21
(part 1) and 1.11 (part 2), with two-sided 95% confidence interval lower limits (0.94 and 0.87, respectively)
greater than the prespecified non-inferiority margin (0.5), thus meeting the primary study objective. No
safety concerns were identified. Despite reduced O-acetylation of MenA and increased FS content,
serogroup-specific immune responses induced by the fully liquid presentation were similar to those
induced by the licensed MenACWY-CRM vaccine, with non-inferior anti-MenA responses. The safety
profiles of the vaccine presentations were similar. | pt_BR |
