Immunogenicity and safety of a tetanus-diphtheria vaccine and a 13-valent pneumococcal conjugate vaccine after concomitant vaccination in ≥ 50-year-old adults
Abstract Background When two or more vaccines are administered concurrently, there is concern about safety and immunogenicity from vaccine interaction. Methods Subjects aged ≥50 years were randomized 1:1:1 to receive tetanus-diphtheria (Td) + 13-valent pneumococcal conjugate vaccine (PCV13; Group 1)...
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| Format: | Article |
| Language: | English |
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BMC
2018-12-01
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| Series: | BMC Infectious Diseases |
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| Online Access: | http://link.springer.com/article/10.1186/s12879-018-3479-9 |
| _version_ | 1818413100158681088 |
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| author | Joon Young Song Hee Jin Cheong Ji Yun Noh Min Joo Choi Jin Gu Yoon Saem Na Lee Seong Hui Kang Eun Joo Jeong Yu Mi Jo Woo Joo Kim |
| author_facet | Joon Young Song Hee Jin Cheong Ji Yun Noh Min Joo Choi Jin Gu Yoon Saem Na Lee Seong Hui Kang Eun Joo Jeong Yu Mi Jo Woo Joo Kim |
| author_sort | Joon Young Song |
| collection | DOAJ |
| description | Abstract Background When two or more vaccines are administered concurrently, there is concern about safety and immunogenicity from vaccine interaction. Methods Subjects aged ≥50 years were randomized 1:1:1 to receive tetanus-diphtheria (Td) + 13-valent pneumococcal conjugate vaccine (PCV13; Group 1), PCV13 alone (Group 2), or Td alone (Group 3). After single or concomitant vaccination, enzyme-linked immunosorbent assay and opsonophagocytic assay (OPA) were performed to compare immunogenicity for Td and PCV13, respectively. Results A total of 448 subjects were available for the assessment. After concomitant administration, the non-inferiority criteria of geometric mean titer (GMT) ratios were met for tetanus, diphtheria, and all four pneumococcal serotypes (1, 5, 18C, and 19A). However, subjects in Group 3 (Td alone) were more likely to have a high IgG anti-tetanus antibody titer (≥ 0.5 U/mL) than those in Group 1 (Td + PCV13) (p < 0.01). As for the pneumococcal serotype 1, the OPA GMT was significantly higher in Group 1 (PCV13 + Td) compared to Group 2 (PCV13 alone) (p = 0.02). No serious adverse event occurred. Conclusions Concomitant Td and PCV13 administration induced sufficient immunity without significant interference and showed good safety profiles. Trials registration NCT03552445 registered at http://www.clinicaltrials.gov on June 11, 2018 (retrospectively registered). |
| first_indexed | 2024-12-14T10:57:50Z |
| format | Article |
| id | doaj.art-4e93a7ab84bc4b6ea884728cbb4680e0 |
| institution | Directory Open Access Journal |
| issn | 1471-2334 |
| language | English |
| last_indexed | 2024-12-14T10:57:50Z |
| publishDate | 2018-12-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Infectious Diseases |
| spelling | doaj.art-4e93a7ab84bc4b6ea884728cbb4680e02022-12-21T23:04:51ZengBMCBMC Infectious Diseases1471-23342018-12-011811810.1186/s12879-018-3479-9Immunogenicity and safety of a tetanus-diphtheria vaccine and a 13-valent pneumococcal conjugate vaccine after concomitant vaccination in ≥ 50-year-old adultsJoon Young Song0Hee Jin Cheong1Ji Yun Noh2Min Joo Choi3Jin Gu Yoon4Saem Na Lee5Seong Hui Kang6Eun Joo Jeong7Yu Mi Jo8Woo Joo Kim9Division of Infectious Diseases, Department of Internal Medicine, Korea University College of MedicineDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of MedicineDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of MedicineDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of MedicineDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of MedicineDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of MedicineDivision of Infectious Diseases, Department of Internal Medicine, Konyang University HospitalDepartment of Internal Medicine, Hallym University School of MedicineDepartment of Internal Medicine, Gachon University of Gil Medical CenterDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of MedicineAbstract Background When two or more vaccines are administered concurrently, there is concern about safety and immunogenicity from vaccine interaction. Methods Subjects aged ≥50 years were randomized 1:1:1 to receive tetanus-diphtheria (Td) + 13-valent pneumococcal conjugate vaccine (PCV13; Group 1), PCV13 alone (Group 2), or Td alone (Group 3). After single or concomitant vaccination, enzyme-linked immunosorbent assay and opsonophagocytic assay (OPA) were performed to compare immunogenicity for Td and PCV13, respectively. Results A total of 448 subjects were available for the assessment. After concomitant administration, the non-inferiority criteria of geometric mean titer (GMT) ratios were met for tetanus, diphtheria, and all four pneumococcal serotypes (1, 5, 18C, and 19A). However, subjects in Group 3 (Td alone) were more likely to have a high IgG anti-tetanus antibody titer (≥ 0.5 U/mL) than those in Group 1 (Td + PCV13) (p < 0.01). As for the pneumococcal serotype 1, the OPA GMT was significantly higher in Group 1 (PCV13 + Td) compared to Group 2 (PCV13 alone) (p = 0.02). No serious adverse event occurred. Conclusions Concomitant Td and PCV13 administration induced sufficient immunity without significant interference and showed good safety profiles. Trials registration NCT03552445 registered at http://www.clinicaltrials.gov on June 11, 2018 (retrospectively registered).http://link.springer.com/article/10.1186/s12879-018-3479-9Pneumococcal conjugate vaccineTetanusDiphtheriaImmunogenicity |
| spellingShingle | Joon Young Song Hee Jin Cheong Ji Yun Noh Min Joo Choi Jin Gu Yoon Saem Na Lee Seong Hui Kang Eun Joo Jeong Yu Mi Jo Woo Joo Kim Immunogenicity and safety of a tetanus-diphtheria vaccine and a 13-valent pneumococcal conjugate vaccine after concomitant vaccination in ≥ 50-year-old adults BMC Infectious Diseases Pneumococcal conjugate vaccine Tetanus Diphtheria Immunogenicity |
| title | Immunogenicity and safety of a tetanus-diphtheria vaccine and a 13-valent pneumococcal conjugate vaccine after concomitant vaccination in ≥ 50-year-old adults |
| title_full | Immunogenicity and safety of a tetanus-diphtheria vaccine and a 13-valent pneumococcal conjugate vaccine after concomitant vaccination in ≥ 50-year-old adults |
| title_fullStr | Immunogenicity and safety of a tetanus-diphtheria vaccine and a 13-valent pneumococcal conjugate vaccine after concomitant vaccination in ≥ 50-year-old adults |
| title_full_unstemmed | Immunogenicity and safety of a tetanus-diphtheria vaccine and a 13-valent pneumococcal conjugate vaccine after concomitant vaccination in ≥ 50-year-old adults |
| title_short | Immunogenicity and safety of a tetanus-diphtheria vaccine and a 13-valent pneumococcal conjugate vaccine after concomitant vaccination in ≥ 50-year-old adults |
| title_sort | immunogenicity and safety of a tetanus diphtheria vaccine and a 13 valent pneumococcal conjugate vaccine after concomitant vaccination in ≥ 50 year old adults |
| topic | Pneumococcal conjugate vaccine Tetanus Diphtheria Immunogenicity |
| url | http://link.springer.com/article/10.1186/s12879-018-3479-9 |
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