Immunogenicity and safety of the 15-valent pneumococcal conjugate vaccine, a systematic review and meta-analysis

Gernot Wagner; Gerald Gartlehner; Kylie Thaler; Dominic Ledinger; Johanna Feyertag; Irma Klerings; K M Saif-Ur-Rahman; Declan Devane; Kate Olsson; Karam Adel Ali; Sabine Vygen-Bonnet; Heini Salo; Dace Zavadska; Marta Grgič Vitek; Marje Oona; Robert Cunney; David Tuerlinckx; Frederikke Kristensen Lomholt; Isolde Sommer

doi:10.1038/s41541-024-01048-y

Immunogenicity and safety of the 15-valent pneumococcal conjugate vaccine, a systematic review and meta-analysis

NPJ Vaccines. 2024 Dec 30;9(1):257. doi: 10.1038/s41541-024-01048-y.

Authors

Gernot Wagner¹, Gerald Gartlehner^{2

3}, Kylie Thaler², Dominic Ledinger², Johanna Feyertag², Irma Klerings², K M Saif-Ur-Rahman^{4

5}, Declan Devane^{4

5

6}, Kate Olsson⁷, Karam Adel Ali⁷, Sabine Vygen-Bonnet⁸, Heini Salo⁹, Dace Zavadska¹⁰, Marta Grgič Vitek¹¹, Marje Oona¹², Robert Cunney¹³, David Tuerlinckx¹⁴, Frederikke Kristensen Lomholt¹⁵, Isolde Sommer²

Affiliations

¹ Department for Evidence-based Medicine and Evaluation, University for Continuing Education Krems (Danube University Krems), Krems, Austria. [email protected].
² Department for Evidence-based Medicine and Evaluation, University for Continuing Education Krems (Danube University Krems), Krems, Austria.
³ Center for Public Health Methods, RTI International, Research Triangle Park, NC, USA.
⁴ Evidence Synthesis Ireland and Cochrane Ireland, University of Galway, Galway, Ireland.
⁵ School of Nursing and Midwifery, University of Galway, Galway, Ireland.
⁶ HRB-Trials Methodology Research Network, University of Galway, Galway, Ireland.
⁷ European Centre for Disease Prevention and Control, Solna, Sweden.
⁸ Immunisation Unit, Robert Koch Institute, Berlin, Germany.
⁹ Infectious Disease Control and Vaccinations Unit, Department of Health Security, Finnish Institute for Health and Welfare (THL), Helsinki, Finland.
¹⁰ Department of Paediatrics, Children Clinical University Hospital, Rīgas Stradiņa Universitāte, Riga, Latvia.
¹¹ Communicable Diseases Centre, National Institute of Public Health, Ljubljana, Slovenia.
¹² Institute of Family Medicine and Public Health, University of Tartu, Tartu, Estonia.
¹³ Clinical Microbiology, Children's Health Ireland at Temple Street, Dublin, Ireland.
¹⁴ Pediatric Department, Centre Hospitalier Universitaire (CHU) Dinant Godinne UCL Namur, Yvoir, Belgium.
¹⁵ Department of Infectious Disease Epidemiology and Prevention, Statens Serum Institut, Copenhagen, Denmark.

Abstract

Pneumococcal infections are a serious health issue associated with increased morbidity and mortality. This systematic review evaluated the efficacy, effectiveness, immunogenicity, and safety of the pneumococcal conjugate vaccine (PCV)15 compared to other pneumococcal vaccines or no vaccination in children and adults. We identified 20 randomized controlled trials (RCTs). A meta-analysis of six RCTs in infants showed that PCV15 was non-inferior compared with PCV13 for 12 shared serotypes. Based on a meta-analysis of seven RCTs in adults, PCV15 was non-inferior to PCV13 for 13 shared serotypes. For the unique PCV15 serotypes, 22F and 33F, immune responses were higher in infants and adults vaccinated with PCV15 compared to those receiving PCV13. Regarding safety, meta-analyses indicated comparable risks of adverse events between PCV15 and PCV13 in infants. Adults receiving PCV15 had a slightly higher risk of adverse events, though serious events were similar between groups.