Immunogenicity, Safety, and Tolerability of V114, a 15-Valent Pneumococcal Conjugate Vaccine, in Immunocompetent Adults Aged 18-49 Years With or Without Risk Factors for Pneumococcal Disease: A Randomized Phase 3 Trial (PNEU-DAY)

Simple item page
dc.contributor.authorHammitt, Laura L.
dc.contributor.authorQuinn, Dean
dc.contributor.authorJanczewska, Ewa
dc.contributor.authorPasquel, Francisco J.
dc.contributor.authorTytus, Richard
dc.contributor.authorReddy, K. Rajender
dc.contributor.authorAbarca, Katia
dc.contributor.authorKhaertynova, Ilsiyar M.
dc.contributor.authorDagan, Ron
dc.contributor.authorMcCauley, Jennifer
dc.contributor.authorCheon, Kyeongmi
dc.contributor.authorPedley, Alison
dc.contributor.authorSterling, Tina
dc.contributor.authorTamms, Gretchen
dc.contributor.authorMusey, Luwy
dc.contributor.authorBuchwald, Ulrike K.
dc.date.accessioned2025-01-20T21:13:33Z
dc.date.available2025-01-20T21:13:33Z
dc.date.issued2022
dc.description.abstractBackground Adults with certain medical and behavioral factors are at increased risk for pneumococcal disease (PD). Sequential vaccination with 13-valent pneumococcal conjugate vaccine (PCV13) followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) is recommended for at-risk adults in some countries. Methods This phase 3 trial evaluated the safety, tolerability, and immunogenicity of sequential administration of either V114 (a 15-valent PCV containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F) or PCV13, followed 6 months later by PPSV23, in immunocompetent adults aged 18-49 years with or without predefined risk factors for PD (NCT03547167). Overall, 1515 participants were randomized 3:1 to receive either V114 or PCV13, followed by PPSV23. Results Most common solicited adverse events (AEs) following administration of V114 or PCV13 as well as PPSV23 were injection-site pain and fatigue. The proportion of participants with AEs was comparable in both groups. V114 and PCV13 were immunogenic based on opsonophagocytic activity (OPA) geometric mean titers (GMTs) 30 days postvaccination for all serotypes contained in each respective vaccine. OPA GMTs to the 2 unique serotypes in V114 were robust in the V114 group. PPSV23 was immunogenic for all 15 serotypes contained in V114 in both vaccination groups, including 22F and 33F. Conclusions V114 administered alone or sequentially with PPSV23 is well tolerated and immunogenic for all 15 serotypes, including those not contained in PCV13, in immunocompetent adults aged 18-49 years with or without certain medical or behavioral risk factors for PD.
dc.description.funderMerck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc, Kenilworth, New Jersey
dc.fuente.origenWOS
dc.identifier.doi10.1093/ofid/ofab605
dc.identifier.issn2328-8957
dc.identifier.urihttps://doi.org/10.1093/ofid/ofab605
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/93710
dc.identifier.wosidWOS:000753114000016
dc.issue.numero3
dc.language.isoen
dc.revistaOpen forum infectious diseases
dc.rightsacceso restringido
dc.subjectpneumococcal vaccine
dc.subjectV114
dc.subject15-valent PCV
dc.subjectPCV13
dc.subjectPPSV23
dc.subject.ods03 Good Health and Well-being
dc.subject.odspa03 Salud y bienestar
dc.titleImmunogenicity, Safety, and Tolerability of V114, a 15-Valent Pneumococcal Conjugate Vaccine, in Immunocompetent Adults Aged 18-49 Years With or Without Risk Factors for Pneumococcal Disease: A Randomized Phase 3 Trial (PNEU-DAY)
dc.typeartículo
dc.volumen9
sipa.indexWOS
sipa.trazabilidadWOS;2025-01-12
Files
Collections
Artículos de revistas