Immunogenicity and safety of a tetanus-diphtheria vaccine and a 13-valent pneumococcal conjugate vaccine after concomitant vaccination in >= 50-year-old adultsopen access
- Authors
- Song, Joon Young; Cheong, Hee Jin; Noh, Ji Yun; Choi, Min Joo; Yoon, Jin Gu; Lee, Saem Na; Kang, Seong Hui; Jeong, Eun Joo; Jo, Yu Mi; Kim, Woo Joo
- Issue Date
- Dec-2018
- Publisher
- BioMed Central
- Keywords
- Pneumococcal conjugate vaccine; Tetanus; Diphtheria; Immunogenicity
- Citation
- BMC Infectious Diseases, v.18, no.1
- Indexed
- SCIE
SCOPUS
- Journal Title
- BMC Infectious Diseases
- Volume
- 18
- Number
- 1
- URI
- https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/2826
- DOI
- 10.1186/s12879-018-3479-9
- ISSN
- 1471-2334
- 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).
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- Appears in
Collections - 2. Clinical Science > Department of Internal Medicine > 1. Journal Articles
- 2. Clinical Science > Department of Infectious Diseases > 1. Journal Articles
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