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
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)...
Saved in:
| Main Authors: | , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2025-06-01
|
| Series: | Vaccine: X |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2590136225000488 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850137059734323200 |
|---|---|
| author | 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 |
| author_facet | 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 |
| author_sort | Muhammad Zain Ul Haq |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-77060411a1ba419989f7675e1094881a |
| institution | OA Journals |
| issn | 2590-1362 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Vaccine: X |
| spelling | doaj-art-77060411a1ba419989f7675e1094881a2025-08-20T02:30:58ZengElsevierVaccine: X2590-13622025-06-012410065410.1016/j.jvacx.2025.100654Immunogenicity, 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-analysisMuhammad Zain Ul Haq0Hamza Irfan1Muhammad Shahmeer Ullah Shah2Anusha Sumbal3Sanila Mughal4Saad Ashraf5Areeba Aamir Ali Basaria6 Abdullah7Muhammad Aaqib Chacho8Biruk Demisse Ayalew9Department of Medicine, Dow University of Health Sciences, Karachi, PakistanDepartment of Medicine, Shaikh Khalifa Bin Zayed Al Nahyan Medical and Dental College, Lahore, PakistanDepartment of Medicine, Dow University of Health Sciences, Karachi, PakistanDepartment of Medicine, Dow University of Health Sciences, Karachi, PakistanDepartment of Medicine, Dow University of Health Sciences, Karachi, PakistanDepartment of Medicine, Dow University of Health Sciences, Karachi, PakistanDepartment of Medicine, Dow University of Health Sciences, Karachi, PakistanDepartment of Medicine, Rawalpindi Medical University, Rawalpindi, PakistanDepartment of Medicine, Dow University of Health Sciences, Karachi, PakistanSt. Paul's Hospital Millennium Medical College, Addis Ababa, Ethiopia; Corresponding author.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.http://www.sciencedirect.com/science/article/pii/S2590136225000488Pneumococcal conjugate vaccinesPCV13V114ImmunogenicitySafetyMeta-analysis |
| spellingShingle | 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 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 Vaccine: X Pneumococcal conjugate vaccines PCV13 V114 Immunogenicity Safety Meta-analysis |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Pneumococcal conjugate vaccines PCV13 V114 Immunogenicity Safety Meta-analysis |
| url | http://www.sciencedirect.com/science/article/pii/S2590136225000488 |
| work_keys_str_mv | AT muhammadzainulhaq immunogenicitysafetyandtolerabilityof15valentpneumococcalconjugatevaccinev114comparedto13valentpneumococcalconjugatevaccinepcv13inhealthyinfantsasystematicreviewandmetaanalysis AT hamzairfan immunogenicitysafetyandtolerabilityof15valentpneumococcalconjugatevaccinev114comparedto13valentpneumococcalconjugatevaccinepcv13inhealthyinfantsasystematicreviewandmetaanalysis AT muhammadshahmeerullahshah immunogenicitysafetyandtolerabilityof15valentpneumococcalconjugatevaccinev114comparedto13valentpneumococcalconjugatevaccinepcv13inhealthyinfantsasystematicreviewandmetaanalysis AT anushasumbal immunogenicitysafetyandtolerabilityof15valentpneumococcalconjugatevaccinev114comparedto13valentpneumococcalconjugatevaccinepcv13inhealthyinfantsasystematicreviewandmetaanalysis AT sanilamughal immunogenicitysafetyandtolerabilityof15valentpneumococcalconjugatevaccinev114comparedto13valentpneumococcalconjugatevaccinepcv13inhealthyinfantsasystematicreviewandmetaanalysis AT saadashraf immunogenicitysafetyandtolerabilityof15valentpneumococcalconjugatevaccinev114comparedto13valentpneumococcalconjugatevaccinepcv13inhealthyinfantsasystematicreviewandmetaanalysis AT areebaaamiralibasaria immunogenicitysafetyandtolerabilityof15valentpneumococcalconjugatevaccinev114comparedto13valentpneumococcalconjugatevaccinepcv13inhealthyinfantsasystematicreviewandmetaanalysis AT abdullah immunogenicitysafetyandtolerabilityof15valentpneumococcalconjugatevaccinev114comparedto13valentpneumococcalconjugatevaccinepcv13inhealthyinfantsasystematicreviewandmetaanalysis AT muhammadaaqibchacho immunogenicitysafetyandtolerabilityof15valentpneumococcalconjugatevaccinev114comparedto13valentpneumococcalconjugatevaccinepcv13inhealthyinfantsasystematicreviewandmetaanalysis AT birukdemisseayalew immunogenicitysafetyandtolerabilityof15valentpneumococcalconjugatevaccinev114comparedto13valentpneumococcalconjugatevaccinepcv13inhealthyinfantsasystematicreviewandmetaanalysis |