Immunogenicity and Safety of the Higher-Valent Pneumococcal Conjugate Vaccine vs the 13-Valent Pneumococcal Conjugate Vaccine in Older Adults: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.