Serotype-specific serum immunoglobulin G at 18 months of age following one or two doses of a primary series of 10-valent or 13-valent pneumococcal conjugate vaccine and a booster dose at nine months of age: a randomized controlled study
Background Due to high costs of pneumococcal conjugate vaccines (PCV), transitioning from a two (2 + 1) to a single dose (1 + 1) primary series with a booster should be considered. This study evaluated the immune response at 18 months of age following a 1 + 1 compared to a 2 + 1 schedule of 10-valen...
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| Format: | Article |
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Taylor & Francis Group
2025-12-01
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| Series: | Expert Review of Vaccines |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/14760584.2025.2458179 |
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| author | Alane Izu Eleanora Aml Mutsaerts Courtney Olwagen Lisa Jose Anthonet Koen Amit J Nana Clare L. Cutland Shabir A. Madhi |
| author_facet | Alane Izu Eleanora Aml Mutsaerts Courtney Olwagen Lisa Jose Anthonet Koen Amit J Nana Clare L. Cutland Shabir A. Madhi |
| author_sort | Alane Izu |
| collection | DOAJ |
| description | Background Due to high costs of pneumococcal conjugate vaccines (PCV), transitioning from a two (2 + 1) to a single dose (1 + 1) primary series with a booster should be considered. This study evaluated the immune response at 18 months of age following a 1 + 1 compared to a 2 + 1 schedule of 10-valent (PCV10) and 13-valent (PCV13) vaccines.Research design and methods A single-center, open-label, randomized trial conducted in Soweto, South Africa, evaluated the immunogenicity of differing dosing schedule for PCV10 and PCV13. Six hundred children were randomly assigned to six study arms (1:1:1:1:1:1). Non-inferiority was concluded when the lower limit of the 96% confidence interval of the ratio of geometric mean concentrations (GMCs) of the 1 + 1 and 2 + 1 schedules was >0.5 for at least 10 and eight of the PCV13 and PCV10 serotypes, respectively.Results GMCs in children who received the PCV13_6w + 1 and PCV13_14w + 1 schedule were non-inferior for 11 and 10 of the PCV13 serotypes, respectively, compared with the PCV13_2 + 1 arm. For PCV10, GMCs for both 1 + 1 schedules were non-inferior to a 2 + 1 schedule for nine of the PCV10 serotypes.Conclusion Transitioning to a 1 + 1 schedule should be considered for early immunization programs.Clinical trial registration www.clinicaltrials.gov identifier is NCT02943902. |
| format | Article |
| id | doaj-art-2f17eae1645140fa9e14d913a2e554c6 |
| institution | Kabale University |
| issn | 1476-0584 1744-8395 |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Expert Review of Vaccines |
| spelling | doaj-art-2f17eae1645140fa9e14d913a2e554c62025-01-27T16:22:37ZengTaylor & Francis GroupExpert Review of Vaccines1476-05841744-83952025-12-0124112112710.1080/14760584.2025.2458179Serotype-specific serum immunoglobulin G at 18 months of age following one or two doses of a primary series of 10-valent or 13-valent pneumococcal conjugate vaccine and a booster dose at nine months of age: a randomized controlled studyAlane Izu0Eleanora Aml Mutsaerts1Courtney Olwagen2Lisa Jose3Anthonet Koen4Amit J Nana5Clare L. Cutland6Shabir A. Madhi7South Africa Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South AfricaSouth Africa Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South AfricaSouth Africa Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South AfricaSouth Africa Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South AfricaSouth Africa Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South AfricaSouth Africa Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South AfricaAfrican Leadership in Vaccinology Expertise, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South AfricaSouth Africa Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South AfricaBackground Due to high costs of pneumococcal conjugate vaccines (PCV), transitioning from a two (2 + 1) to a single dose (1 + 1) primary series with a booster should be considered. This study evaluated the immune response at 18 months of age following a 1 + 1 compared to a 2 + 1 schedule of 10-valent (PCV10) and 13-valent (PCV13) vaccines.Research design and methods A single-center, open-label, randomized trial conducted in Soweto, South Africa, evaluated the immunogenicity of differing dosing schedule for PCV10 and PCV13. Six hundred children were randomly assigned to six study arms (1:1:1:1:1:1). Non-inferiority was concluded when the lower limit of the 96% confidence interval of the ratio of geometric mean concentrations (GMCs) of the 1 + 1 and 2 + 1 schedules was >0.5 for at least 10 and eight of the PCV13 and PCV10 serotypes, respectively.Results GMCs in children who received the PCV13_6w + 1 and PCV13_14w + 1 schedule were non-inferior for 11 and 10 of the PCV13 serotypes, respectively, compared with the PCV13_2 + 1 arm. For PCV10, GMCs for both 1 + 1 schedules were non-inferior to a 2 + 1 schedule for nine of the PCV10 serotypes.Conclusion Transitioning to a 1 + 1 schedule should be considered for early immunization programs.Clinical trial registration www.clinicaltrials.gov identifier is NCT02943902.https://www.tandfonline.com/doi/10.1080/14760584.2025.2458179Pneumococcal conjugate vaccinesimmunityimmune responsesinvasive pneumococcal diseasevaccinology |
| spellingShingle | Alane Izu Eleanora Aml Mutsaerts Courtney Olwagen Lisa Jose Anthonet Koen Amit J Nana Clare L. Cutland Shabir A. Madhi Serotype-specific serum immunoglobulin G at 18 months of age following one or two doses of a primary series of 10-valent or 13-valent pneumococcal conjugate vaccine and a booster dose at nine months of age: a randomized controlled study Expert Review of Vaccines Pneumococcal conjugate vaccines immunity immune responses invasive pneumococcal disease vaccinology |
| title | Serotype-specific serum immunoglobulin G at 18 months of age following one or two doses of a primary series of 10-valent or 13-valent pneumococcal conjugate vaccine and a booster dose at nine months of age: a randomized controlled study |
| title_full | Serotype-specific serum immunoglobulin G at 18 months of age following one or two doses of a primary series of 10-valent or 13-valent pneumococcal conjugate vaccine and a booster dose at nine months of age: a randomized controlled study |
| title_fullStr | Serotype-specific serum immunoglobulin G at 18 months of age following one or two doses of a primary series of 10-valent or 13-valent pneumococcal conjugate vaccine and a booster dose at nine months of age: a randomized controlled study |
| title_full_unstemmed | Serotype-specific serum immunoglobulin G at 18 months of age following one or two doses of a primary series of 10-valent or 13-valent pneumococcal conjugate vaccine and a booster dose at nine months of age: a randomized controlled study |
| title_short | Serotype-specific serum immunoglobulin G at 18 months of age following one or two doses of a primary series of 10-valent or 13-valent pneumococcal conjugate vaccine and a booster dose at nine months of age: a randomized controlled study |
| title_sort | serotype specific serum immunoglobulin g at 18 months of age following one or two doses of a primary series of 10 valent or 13 valent pneumococcal conjugate vaccine and a booster dose at nine months of age a randomized controlled study |
| topic | Pneumococcal conjugate vaccines immunity immune responses invasive pneumococcal disease vaccinology |
| url | https://www.tandfonline.com/doi/10.1080/14760584.2025.2458179 |
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