PMID- 38267330 OWN - NLM STAT- MEDLINE DCOM- 20240226 LR - 20240226 IS - 1873-2518 (Electronic) IS - 0264-410X (Linking) VI - 42 IP - 5 DP - 2024 Feb 15 TI - A phase 3 randomized trial of the safety and immunogenicity of 20-valent pneumococcal conjugate vaccine in adults >/= 60 years of age in Japan, South Korea, and Taiwan. PG - 1071-1077 LID - S0264-410X(24)00008-2 [pii] LID - 10.1016/j.vaccine.2024.01.004 [doi] AB - BACKGROUND: Pneumococcal infections are associated with high disease burden in older individuals in Japan, South Korea, and Taiwan. The 20-valent pneumococcal conjugate vaccine (PCV20) was developed to extend protection beyond earlier pneumococcal vaccines. METHODS: This phase 3 randomized, double-blind study investigated the safety and immunogenicity of PCV20 in participants >/= 60 years of age from Japan, South Korea, and Taiwan. Participants were randomized to receive PCV20 or 13-valent pneumococcal conjugate vaccine (PCV13). One month after vaccination, PCV20 recipients received a saline injection and PCV13 recipients received 23-valent polysaccharide vaccine (PPSV23). Primary immunogenicity objectives were to demonstrate noninferiority of PCV20 to PCV13 (13 matched serotypes) or PPSV23 (7 additional serotypes) for serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) 1 month after vaccination with PCV20, PCV13, or PPSV23. Noninferiority for each serotype was declared if the lower bound of the 2-sided 95% CI for OPA geometric mean ratio (GMR) was > 0.5. Safety endpoints included local reactions, systemic events, adverse events (AEs), and serious AEs. RESULTS: Overall, 1421‬ participants were vaccinated (median age [range]: 65 [60-85] years). PCV20 was noninferior to PCV13 for all 13 matched serotypes and to PPSV23 for 6 of 7 additional serotypes. Although statistical noninferiority was missed for serotype 8 (lower bound of the 2-sided 95% CI for OPA GMR = 0.5, thus not meeting the statistical noninferiority criterion of > 0.5), secondary immunogenicity endpoints for serotype 8 were supportive of a robust immune response. The incidence of AEs and the frequency and severity of local reactions and systemic events were generally similar after PCV20 and PCV13. No safety concerns were identified. CONCLUSION: PCV20 generated robust immune responses to all vaccine serotypes in older adults in Japan, South Korea, and Taiwan. The safety and tolerability profile was similar to PCV13. PCV20 is expected to help protect against all 20 vaccine serotypes. NCT04875533. CI - Copyright (c) 2024 The Authors. Published by Elsevier Ltd.. All rights reserved. FAU - Haranaka, Miwa AU - Haranaka M AD - SOUSEIKAI PS Clinic, Fukuoka, Japan. FAU - Young Song, Joon AU - Young Song J AD - Korea University Guro Hospital, Seoul, South Korea. FAU - Huang, Kuo-Chin AU - Huang KC AD - National Taiwan University Hospital, Taipei, Taiwan. FAU - de Solom, Richard AU - de Solom R AD - Vaccine Clinical Research & Development, Pfizer Australia, Sydney, NSW, Australia. FAU - Yamaji, Masako AU - Yamaji M AD - Vaccine Research, Pfizer R&D Japan, Tokyo, Japan. Electronic address: masako.yamaji@pfizer.com. FAU - McElwee, Kathleen AU - McElwee K AD - Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA. FAU - Kline, Mary AU - Kline M AD - Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA. FAU - Aizawa, Masakazu AU - Aizawa M AD - Vaccine Research, Pfizer R&D Japan, Tokyo, Japan. FAU - Peng, Yahong AU - Peng Y AD - Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA. FAU - Scully, Ingrid AU - Scully I AD - Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA. FAU - Kogawara, Osamu AU - Kogawara O AD - Vaccine Research, Pfizer R&D Japan, Tokyo, Japan. FAU - Gruber, William C AU - Gruber WC AD - Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA. FAU - Scott, Daniel A AU - Scott DA AD - Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA. FAU - Watson, Wendy AU - Watson W AD - Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA. LA - eng SI - ClinicalTrials.gov/NCT04875533 PT - Clinical Trial, Phase III PT - Journal Article PT - Randomized Controlled Trial DEP - 20240123 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Vaccines, Conjugate) RN - 0 (Antibodies, Bacterial) RN - 0 (Pneumococcal Vaccines) SB - IM MH - Humans MH - Aged MH - *Streptococcus pneumoniae MH - Vaccines, Conjugate/adverse effects MH - Japan MH - Taiwan MH - Antibodies, Bacterial MH - *Pneumococcal Infections/epidemiology MH - Pneumococcal Vaccines/adverse effects MH - Double-Blind Method MH - Republic of Korea MH - Immunogenicity, Vaccine OTO - NOTNLM OT - 20-valent pneumococcal conjugate vaccine OT - Asian OT - Clinical study OT - Immunogenicity OT - Safety OT - Streptococcus pneumoniae COIS- Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: RdS, MY, MK, KM, MA, YP, ILS, OK, WCG, DAS, and WW are current or former employees of Pfizer Inc and may hold stock or stock options. MH, JYS, and KH were Pfizer investigators for this study. JYS has also received research grants from Pfizer and MSD. EDAT- 2024/01/25 00:42 MHDA- 2024/02/26 06:43 CRDT- 2024/01/24 21:56 PHST- 2023/11/13 00:00 [received] PHST- 2023/12/28 00:00 [revised] PHST- 2024/01/02 00:00 [accepted] PHST- 2024/02/26 06:43 [medline] PHST- 2024/01/25 00:42 [pubmed] PHST- 2024/01/24 21:56 [entrez] AID - S0264-410X(24)00008-2 [pii] AID - 10.1016/j.vaccine.2024.01.004 [doi] PST - ppublish SO - Vaccine. 2024 Feb 15;42(5):1071-1077. doi: 10.1016/j.vaccine.2024.01.004. Epub 2024 Jan 23.