Immunogenicity, safety and tolerability of 15-valent pneumococcal conjugate vaccine (V114) compared to 13-valent pneumococcal conjugate vaccine (PCV-13) in healthy infants: A systematic review and meta-analysis

IF 2.7 Q3 IMMUNOLOGY

Vaccine: X Pub Date : 2025-05-21 DOI:10.1016/j.jvacx.2025.100654

Muhammad Zain Ul Haq , Hamza Irfan , Muhammad Shahmeer Ullah Shah , Anusha Sumbal , Sanila Mughal , Saad Ashraf , Areeba Aamir Ali Basaria , Abdullah , Muhammad Aaqib Chacho , Biruk Demisse Ayalew

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引用次数: 0

Abstract

Introduction

Streptococcus pneumoniae is a major cause of infectious diseases, particularly in children under 5, leading to approximately 300,000 deaths annually. The introduction of pneumococcal conjugate vaccines (PCVs), such as PCV13, has significantly reduced invasive pneumococcal disease (IPD). However, rising cases of IPD caused by non-vaccine serotypes highlight the need for broader coverage vaccines like PCV15 (V114). This study aims to evaluate the immunogenicity and safety of V114 compared to PCV13 in healthy infants.

Methods

This systematic review and meta-analysis followed PRISMA guidelines and was registered with PROSPERO (CRD42024576730). Two reviewers searched MEDLINE, Google Scholar, and Cochrane databases for randomized controlled trials (RCTs) comparing V114 and PCV13 in infants. Data were extracted on immunogenicity (IgG response and geometric mean concentration) and safety outcomes. Meta-regression was conducted using R software for variables where heterogeneity could not be explained through subgroup analysis or leave-one-out analysis.

Results

A total of 11 RCTs involving 9970 infants were included. Immunogenicity results indicated higher seropositivity for shared serotypes in PCV13, while V114 showed superior responses for unique serotypes (22F and 33F). No significant differences in overall adverse effects were observed between the two vaccines, although injection-site pain was more common with V114 and urticaria was noted more frequently with PCV13.

Conclusion

V114 demonstrated enhanced immunogenicity for certain serotypes and comparable safety profiles to PCV13. The findings support the potential of V114 to address the limitations of current vaccines, particularly against non-vaccine serotypes. Further research is necessary to evaluate long-term immunity and real-world effectiveness.

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15价肺炎球菌结合疫苗（V114）与13价肺炎球菌结合疫苗（PCV-13）在健康婴儿中的免疫原性、安全性和耐受性：一项系统综述和荟萃分析

肺炎链球菌是传染病的主要病因，特别是在5岁以下儿童中，每年导致约30万人死亡。引入肺炎球菌结合疫苗（pcv），如PCV13，显著减少了侵袭性肺炎球菌病（IPD）。然而，由非疫苗血清型引起的IPD病例不断增加，这突出表明需要更广泛覆盖的疫苗，如PCV15 （V114）。本研究旨在评价V114与PCV13在健康婴儿中的免疫原性和安全性。方法本系统评价和荟萃分析遵循PRISMA指南，并在PROSPERO注册（CRD42024576730）。两名审稿人检索了MEDLINE、b谷歌Scholar和Cochrane数据库，寻找比较V114和PCV13在婴儿中的随机对照试验（RCTs）。提取免疫原性（IgG应答和几何平均浓度）和安全性结果的数据。对于无法通过亚组分析或留一分析解释异质性的变量，使用R软件进行meta回归。结果共纳入11项随机对照试验，共9970例婴儿。免疫原性结果显示PCV13对共有血清型有较高的血清阳性反应，而V114对独特血清型（22F和33F）有较好的反应。两种疫苗的总体不良反应没有显著差异，尽管V114疫苗的注射部位疼痛更常见，PCV13疫苗的荨麻疹更常见。结论v114对某些血清型具有更强的免疫原性，其安全性与PCV13相当。研究结果支持V114有潜力解决当前疫苗的局限性，特别是针对非疫苗血清型。需要进一步的研究来评估长期免疫力和实际效果。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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