SOUSEIKAI PS Clinic, Fukuoka, Japan.
Korea University Guro Hospital, Seoul, South Korea.
Vaccine. 2024 Feb 15;42(5):1071-1077. doi: 10.1016/j.vaccine.2024.01.004. Epub 2024 Jan 23.
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.
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.
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.
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.
肺炎球菌感染在日本、韩国和中国台湾的老年人中与较高的疾病负担相关。20 价肺炎球菌结合疫苗（PCV20）的开发旨在扩大对早期肺炎球菌疫苗的保护范围。
这项 3 期、随机、双盲研究调查了 PCV20 在日本、韩国和中国台湾的≥60 岁参与者中的安全性和免疫原性。参与者被随机分配接受 PCV20 或 13 价肺炎球菌结合疫苗（PCV13）。接种后 1 个月，PCV20 组接受生理盐水注射，PCV13 组接受 23 价多糖疫苗（PPSV23）。主要免疫原性目标是证明 PCV20 在接种 PCV20、PCV13 或 PPSV23 1 个月后的血清型特异性调理吞噬活性（OPA）几何平均滴度（GMT）方面不劣于 PCV13（13 个匹配血清型）或 PPSV23（7 个额外血清型）。如果 OPA 几何平均比（GMR）的双侧 95%CI 的下限大于 0.5，则宣布每个血清型的非劣效性。安全性终点包括局部反应、全身事件、不良事件（AE）和严重不良事件（SAE）。
共有 1421 名参与者接种了疫苗（中位年龄[范围]：65[60-85]岁）。PCV20 在所有 13 个匹配血清型方面不劣于 PCV13，在 7 个额外血清型中的 6 个方面不劣于 PPSV23。虽然血清型 8 的统计学非劣效性未达到（OPA GMR 的双侧 95%CI 的下限为 0.5，因此不符合>0.5 的统计学非劣效性标准），但血清型 8 的次要免疫原性终点支持了强大的免疫反应。接种 PCV20 和 PCV13 后，AE 的发生率以及局部反应和全身事件的频率和严重程度通常相似。未发现安全性问题。
PCV20 在日本、韩国和中国台湾的老年人中对所有疫苗血清型产生了强大的免疫应答。安全性和耐受性特征与 PCV13 相似。PCV20 有望帮助预防所有 20 种疫苗血清型。NCT04875533。
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