Phase 3 trial to evaluate the safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by 23-valent pneumococcal polysaccharide vaccine 6 months later, in at-risk adults 18-49 years of age (PNEU-DAY): A subgroup analysis by baseline risk factors

• Type of Material: Article
• Authors: Laura L Hammitt, Johns Hopkins Bloomberg School of Public Health; Dean Quinn, Wellington Clinical Trial Research Unit; Ewa Janczewska, Medical University of Silesia; Francisco Pasquel, Emory University; Richard Tytus, McMaster University; Rajender K Reddy, University of Pennsylvania; Katia Abarca, Pontificia Univ Catolica Chile; Ilsiyar MM Khaertynova, Kazan State Medical Academy; Ron Dagan, Ben-Gurion University of the Negev; Rachel Dawson, Merck & Co Inc; Jennifer McCauley, Merck & Co Inc; Tulin Shekar, Merck & Co Inc; Wei Fu, Merck & Co Inc; Alison Pedley, Merck & Co Inc; Tina Sterling, Merck & Co Inc; Gretchen Tamms, Merck & Co Inc; Luwy Musey, Merck & Co Inc; Ulrike K Buchwald, Merck & Co Inc
• Language: English
• Date: 2023-03-02
• Publisher: TAYLOR & FRANCIS INC
• Publication Version: Final Published Version
• Copyright Statement: © 2023 Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Published with license by Taylor & Francis Group, LLC.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1080/21645515.2023.2177066
• Title of Journal or Parent Work: HUMAN VACCINES & IMMUNOTHERAPEUTICS
• Volume: 19
• Issue: 1
• Start Page: 2177066
• End Page: 2177066
• Grant/Funding Information: This study was supported by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
• Keywords: Biotechnology & Applied Microbiology; ENGLAND; Life Sciences & Biomedicine; DISEASE; IMPACT; at-risk adults; 15-valent PCV; Immunology; Pneumococcal vaccine; PPSV23; V114; Science & Technology; COMMUNITY-ACQUIRED PNEUMONIA; PCV13
• Research Categories: Health Sciences, Medicine and Surgery

Abstract

Immunocompetent adults with certain medical and behavioral factors are at increased risk of pneumococcal disease. In some countries, sequential vaccination with 13-valent pneumococcal conjugate vaccine (PCV13) followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) is recommended for at-risk adults. This subgroup analysis from a phase 3 study 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 18–49 years of age with pre-defined risk factors for pneumococcal disease. Safety and immunogenicity post-vaccination were analyzed by type and baseline number of risk factors for pneumococcal disease (1 and ≥2 risk factors). This analysis included 1,131 participants randomized 3:1 to receive either V114 or PCV13, followed by PPSV23. The majority (73.1%) of participants had at least one risk factor. Safety and tolerability profiles of V114 and PCV13 were similar across risk factor groups. V114 administered either alone or sequentially with PPSV23 6 months later was immunogenic for all 15 serotypes, including those not contained in PCV13, regardless of the number of baseline risk factors. V114 has the potential to broaden serotype coverage for at-risk adults.