Immunogenicity and safety of a tetanus-diphtheria vaccine and a 13-valent pneumococcal conjugate vaccine after concomitant vaccination in ≥ 50-year-old adults

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, 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

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).

Keywords: Diphtheria; Immunogenicity; Pneumococcal conjugate vaccine; Tetanus.

Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the Research and Ethical Review Committees at the Korea University Guro Hospital, Seoul, South Korea. Written informed consent was obtained from patients before enrollment into the study.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study flow chart (Td, tetanus-diphtheria; PCV13, 13-valent pneumococcal conjugate vaccine)
Fig. 2
Fig. 2
Comparison of geometric mean titers at one month post-vaccination. Enzyme-linked immunosorbent assay: tetanus-diphtheria (Td) vaccine + 13-valent pneumococcal conjugate vaccine (Group 1) versus Td vaccine alone (Group 3). Opsonophagocytic activity (OPA): Td vaccine + 13-valent pneumococcal conjugate vaccine (Group 1) versus 13-valent pneumococcal conjugate vaccine alone (Group 2)

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