Abstract
BackgroundWhen two or more vaccines are administered concurrently, there is concern about safety and immunogenicity from vaccine interaction.MethodsSubjects 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.ResultsA 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.ConclusionsConcomitant Td and PCV13 administration induced sufficient immunity without significant interference and showed good safety profiles.Trials registrationNCT03552445 registered at http://www.clinicaltrials.gov on June 11, 2018 (retrospectively registered).
Highlights
When two or more vaccines are administered concurrently, there is concern about safety and immunogenicity from vaccine interaction
We aimed to evaluate the immunogenicity and safety of the Td vaccine and 13-valent pneumococcal conjugate vaccine (PCV13) after concomitant administration in adults aged 50 years and older
Baseline characteristics A total of 487 subjects were initially recruited, and 462 of them were randomly assigned at a 1:1:1 ratio to one of three vaccination groups: Td + PCV13 (Group 1), PCV13 alone (Group 2), and Td alone (Group 3; Fig. 1)
Summary
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). Vaccination is the most effective strategy to prevent diverse infectious diseases. When a patient visits a vaccination clinic, Td and the pneumococcal vaccines are commonly administered at the same time. Pneumococcal vaccines are recommended for chronically ill patients and the elderly aged ≥65 years, while a booster dose of the Td vaccine is required every 10 years from the age of 11–12 years due to waning immunity [2, 3]. Tetanus can be prevented only by vaccination because immunity against this disease is not naturally acquired [4, 5]. Herd protection cannot be induced because tetanus is not person-to-person transmitted
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