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

When two or more vaccines are administered concurrently, there is concern about safety and immunogenicity from vaccine interaction. 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...

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Published inBMC infectious diseases Vol. 18; no. 1; pp. 628 - 8
Main 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
Format Journal Article
LanguageEnglish
Published England BioMed Central Ltd 05.12.2018
BioMed Central
BMC
Subjects
Adults
Conjugates
Diphtheria
Enzyme-linked immunosorbent assay
Health aspects
Hepatitis
Immunity
Immunogenicity
Immunoglobulin G
Infectious diseases
Influenza
Pneumococcal conjugate vaccine
Pneumococcal vaccines
Proteins
Safety
Safety and security measures
Serotypes
Streptococcus infections
Tetanus
Vaccination
Vaccines
Whooping cough
Pneumococcal conjugate vaccine
Tetanus
Immunogenicity
Diphtheria
Online AccessGet full text
ISSN1471-2334
1471-2334
DOI10.1186/s12879-018-3479-9

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Abstract When two or more vaccines are administered concurrently, there is concern about safety and immunogenicity from vaccine interaction. 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. 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. Concomitant Td and PCV13 administration induced sufficient immunity without significant interference and showed good safety profiles. NCT03552445 registered at http://www.clinicaltrials.gov on June 11, 2018 (retrospectively registered).
AbstractList 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).
When two or more vaccines are administered concurrently, there is concern about safety and immunogenicity from vaccine interaction. 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. 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. Concomitant Td and PCV13 administration induced sufficient immunity without significant interference and showed good safety profiles. NCT03552445 registered at http://www.clinicaltrials.gov on June 11, 2018 (retrospectively registered).
When two or more vaccines are administered concurrently, there is concern about safety and immunogenicity from vaccine interaction. Subjects aged [greater than or equai to]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. 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 ([greater than or equai to] 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. Concomitant Td and PCV13 administration induced sufficient immunity without significant interference and showed good safety profiles.
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).
When two or more vaccines are administered concurrently, there is concern about safety and immunogenicity from vaccine interaction.BACKGROUNDWhen two or more vaccines are administered concurrently, there is concern about safety and immunogenicity from vaccine interaction.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.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.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.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.Concomitant Td and PCV13 administration induced sufficient immunity without significant interference and showed good safety profiles.CONCLUSIONSConcomitant Td and PCV13 administration induced sufficient immunity without significant interference and showed good safety profiles.NCT03552445 registered at http://www.clinicaltrials.gov on June 11, 2018 (retrospectively registered).TRIALS REGISTRATIONNCT03552445 registered at http://www.clinicaltrials.gov on June 11, 2018 (retrospectively registered).
Background When two or more vaccines are administered concurrently, there is concern about safety and immunogenicity from vaccine interaction. Methods Subjects aged [greater than or equai to]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 ([greater than or equai to] 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 Keywords: Pneumococcal conjugate vaccine, Tetanus, Diphtheria, Immunogenicity
ArticleNumber 628
Audience Academic
Author Noh, Ji Yun
Kang, Seong Hui
Jo, Yu Mi
Kim, Woo Joo
Jeong, Eun Joo
Song, Joon Young
Choi, Min Joo
Cheong, Hee Jin
Lee, Saem Na
Yoon, Jin Gu
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Issue 1
Keywords Pneumococcal conjugate vaccine
Tetanus
Immunogenicity
Diphtheria
Language English
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Snippet When two or more vaccines are administered concurrently, there is concern about safety and immunogenicity from vaccine interaction. Subjects aged ≥50 years...
When two or more vaccines are administered concurrently, there is concern about safety and immunogenicity from vaccine interaction. Subjects aged [greater than...
Background When two or more vaccines are administered concurrently, there is concern about safety and immunogenicity from vaccine interaction. Methods Subjects...
When two or more vaccines are administered concurrently, there is concern about safety and immunogenicity from vaccine interaction.BACKGROUNDWhen two or more...
Abstract Background When two or more vaccines are administered concurrently, there is concern about safety and immunogenicity from vaccine interaction. Methods...
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StartPage 628
SubjectTerms Adults
Conjugates
Diphtheria
Enzyme-linked immunosorbent assay
Health aspects
Hepatitis
Immunity
Immunogenicity
Immunoglobulin G
Infectious diseases
Influenza
Pneumococcal conjugate vaccine
Pneumococcal vaccines
Proteins
Safety
Safety and security measures
Serotypes
Streptococcus infections
Tetanus
Vaccination
Vaccines
Whooping cough
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Title Immunogenicity and safety of a tetanus-diphtheria vaccine and a 13-valent pneumococcal conjugate vaccine after concomitant vaccination in ≥ 50-year-old adults
URI https://www.ncbi.nlm.nih.gov/pubmed/30518331
https://www.proquest.com/docview/2158279877
https://www.proquest.com/docview/2155145692
https://pubmed.ncbi.nlm.nih.gov/PMC6282243
https://doaj.org/article/4e93a7ab84bc4b6ea884728cbb4680e0
Volume 18
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