Ngamprasertchai Thundon, Ruenroengbun Narisa, Kajeekul Rattagan
Department of Tropical Hygiene, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Department of Pharmaceutics (Clinical Pharmacy), Faculty of Pharmacy, Slipakorn University, Nakhon Pathom, Thailand.
Open Forum Infect Dis. 2025 Feb 5;12(2):ofaf069. doi: 10.1093/ofid/ofaf069. eCollection 2025 Feb.
The immunogenicity of the 15-valent pneumococcal conjugate vaccine (PCV15) and PCV20 in older adults was approved on the basis of comparative data with PCV13, although their relative immunogenicity and safety in this population remain undetermined. A systematic review and meta-analysis were conducted to provide insights, addressing the lack of large-scale efficacy studies.
This analysis included phase 2 and 3 randomized controlled trials evaluating the immunogenicity of a single dose of PCV15 or PCV20 in older adults by opsonophagocytic assay geometric mean titer (GMT) response at 1 month postvaccination as compared with PCV13.
In total, 8 trials were eligible. PCV15 demonstrated superior immunogenicity vs PCV13 among older adults (GMT ratio, 1.11; 95% CI, 1.02-1.20). In immunogenicity vs PCV13, PCV20 demonstrated noninferiority, exceeding 0.5 at 1 month postvaccination (GMT ratio, 0.84; 95% CI, .81-.87). The incidence of local and systemic reactions was higher in the PCV15 group as compared with the PCV13 group, with risk ratios of 1.23 (95% CI, 1.14-1.32) and 1.15 (95% CI, 1.02-1.29), respectively. PCV20 is well tolerated and exhibits a comparable rate of local and systemic reactions to PCV13.
These findings support the immunogenicity and safety of PCV15 and PCV20 for pneumococcal vaccination in older adults. Given its superior immune response, PCV15 may address the gaps left by PCV13. Despite higher antibody levels, the clinical effectiveness of these vaccines remains uncertain. Ongoing surveillances are essential to evaluate the impact of both vaccines on remaining vaccine-type pneumococcal disease.
15价肺炎球菌结合疫苗（PCV15）和PCV20在老年人中的免疫原性是基于与PCV13的比较数据获批的，尽管它们在该人群中的相对免疫原性和安全性仍未确定。开展了一项系统评价和荟萃分析以提供见解，解决大规模疗效研究的缺乏问题。
该分析纳入了2期和3期随机对照试验，通过与PCV13相比，在接种疫苗后1个月时用调理吞噬试验几何平均滴度（GMT）反应来评估单剂量PCV15或PCV20在老年人中的免疫原性。
总共有8项试验符合条件。在老年人中，PCV15显示出比PCV13更强的免疫原性（GMT比值，1.11；95%置信区间，1.02 - 1.20）。在与PCV13的免疫原性比较中，PCV20显示出非劣效性，在接种疫苗后1个月时超过0.5（GMT比值，0.84；95%置信区间，0.81 - 0.87）。与PCV13组相比，PCV15组局部和全身反应的发生率更高，风险比分别为1.23（95%置信区间，1.14 - 1.32）和1.15（95%置信区间，1.02 - 1.29）。PCV20耐受性良好，局部和全身反应发生率与PCV13相当。
这些发现支持PCV15和PCV20在老年人肺炎球菌疫苗接种中的免疫原性和安全性。鉴于其优越的免疫反应，PCV15可能弥补PCV13留下的空白。尽管抗体水平较高，但这些疫苗的临床有效性仍不确定。持续监测对于评估两种疫苗对剩余疫苗型肺炎球菌疾病的影响至关重要。
