Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by sequential PPSV23 vaccination in healthy adults aged =50 years: A randomized phase III trial (PNEU-PATH)


Por: Song JY, Chang CJ, Andrews C, Diez-Domingo J, Oh MD, Dagan R, Hartzel J, Pedley A, Li J, Sterling T, Tamms G, Chiarappa JA, Lutkiewicz J, Musey L, Tu Y, Buchwald UK and V114-016 (PNEU-PATH) study group

Publicada: 15 oct 2021 Ahead of Print: 1 oct 2021
Resumen:
Background: Streptococcus pneumoniae causes pneumococcal disease, and older adults are at an increased risk. Sequential vaccination of 13-valent pneumococcal conjugate vaccine (PCV13) followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) is recommended for broad protection against pneumococcal disease in some countries. Methods: This phase III 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 12 months later by PPSV23, in healthy adults aged >50 years (NCT03480763). A total of 652 participants were randomized 1:1 to receive either V114 or PCV13, followed by PPSV23. Results: The most common solicited adverse events (AEs) following PCV vaccination included injection-site pain and fatigue. Higher proportions of participants with these events were observed in the V114 group following PCV; however, these differences were not clinically significant. Following PPSV23 vaccination, the most common solicited AEs were injection-site pain and injection-site swelling; the proportions of participants with these events were comparable between both groups. Incidence of serious AEs was low in both groups following PCV and PPSV23, and none were related to study vaccines. No deaths occurred during the study. Serum opsonophagocytic activity geometric mean titers and immunoglobulin G geometric mean concentrations were comparable between both groups for all 15 serotypes in V114 following PPSV23. Immune responses elicited by V114 persisted for at least 12 months. Immune responses at 30 days and 12 months post-vaccination with PCV were comparable between both groups for the 13 shared serotypes and higher in the V114 group for the V114-unique serotypes (22F and 33F). Conclusion: Administration of V114 followed by PPSV23 was well tolerated and induced comparable antibody levels to PCV13 followed by PPSV23 in healthy adults aged >50 years. (c) 2021 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Filiaciones:
Song JY:
 Korea University College of Medicine, Seoul, South Korea

Chang CJ:
 National Cheng Kung University, Tainan, Taiwan

Andrews C:
 Diagnostics Research Group, San Antonio, TX, USA

:
 FISABIO, Valencia, Spain

Oh MD:
 Seoul National University College of Medicine, Seoul, South Korea

Dagan R:
 Ben-Gurion University, Beer-Sheva, Israel

Hartzel J:
 Merck & Co., Inc., Kenilworth, NJ, USA

Pedley A:
 Merck & Co., Inc., Kenilworth, NJ, USA

Li J:
 Merck & Co., Inc., Kenilworth, NJ, USA

Sterling T:
 Merck & Co., Inc., Kenilworth, NJ, USA

Tamms G:
 Merck & Co., Inc., Kenilworth, NJ, USA

Chiarappa JA:
 Merck & Co., Inc., Kenilworth, NJ, USA

Lutkiewicz J:
 Merck & Co., Inc., Kenilworth, NJ, USA

Musey L:
 Merck & Co., Inc., Kenilworth, NJ, USA

Tu Y:
 Merck & Co., Inc., Kenilworth, NJ, USA

Buchwald UK:
 Merck & Co., Inc., Kenilworth, NJ, USA
ISSN: 13588745





Vaccine
Editorial
Elsevier BV, THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND, Países Bajos
Tipo de documento: Article
Volumen: 39 Número: 43
Páginas: 6422-6436
WOS Id: 000715223200014
ID de PubMed: 34489128
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