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Reactogenicity and immunogenicity of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant and nonpregnant women.

Publication ,  Journal Article
Fortner, KB; Swamy, GK; Broder, KR; Jimenez-Truque, N; Zhu, Y; Moro, PL; Liang, J; Walter, EB; Heine, RP; Moody, MA; Yoder, S; Edwards, KM
Published in: Vaccine
October 8, 2018

OBJECTIVE: Tetanus toxoid, reduced diphtheria toxoid, and acellular pertusiss (Tdap) vaccine is recommended during each pregnancy, regardless of prior receipt. Data on reactogenicity and immunogenicity, particularly after repeated Tdap, are limited. We compared local injection-site and systemic reactions and serologic response following Tdap in (1) pregnant and nonpregnant women and (2) pregnant women by self-reported prior Tdap receipt. STUDY DESIGN: Pregnant women (gestational age 20-34 weeks) and nonpregnant women receiving Tdap were enrolled in this observational study. Injection-site and systemic reactions were assessed for one week post-vaccination. Pertussis toxin, filamentous hemagglutinin, pertactin, fimbriae, tetanus and diphtheria specific IgG antibody titers were determined by standardized enzyme-linked immunosorbent assay at baseline and 28 days post-vaccination. Reactogenicity and serologic responses were compared by pregnancy status, and within pregnant women by self-reported prior Tdap receipt. RESULTS: 374 pregnant and 225 nonpregnant women were vaccinated. Severe local or systemic reactions or "any" fever were uncommon (≤3% for both groups). Moderate/severe injection-site pain was significantly higher in pregnant (17.9%) versus nonpregnant (11.1%) women, but did not prompt a healthcare visit. Proportions of other moderate/severe or any severe reactions were not significantly higher in pregnant compared to nonpregnant women. Moderate/severe (including pain) and severe reactions were not significantly higher in pregnant women receiving repeat versus first-time Tdap. Antibody titers increased from baseline to post-vaccination for all vaccine antigens in pregnant and nonpregnant women; post-vaccination titers against pertussis toxin and filamentous hemagglutinin were significantly higher in nonpregnant versus pregnant women (p < 0.01). CONCLUSION: Tdap was well-tolerated in pregnant and nonpregnant women. Pregnant women were more likely to report moderate/severe pain at the Tdap injection-site compared with nonpregnant women, but did not necessitate medical visits. Prior Tdap receipt did not increase occurrence of moderate/severe local or systemic reactions in pregnant women. Serologic responses to all vaccine antigens were robust. Clinical Trial Registration@ClinicalTrials.gov. NCT02209623. https://clinicaltrials.gov/ct2/show/NCT02209623.

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Published In

Vaccine

DOI

EISSN

1873-2518

Publication Date

October 8, 2018

Volume

36

Issue

42

Start / End Page

6354 / 6360

Location

Netherlands

Related Subject Headings

  • Young Adult
  • Whooping Cough
  • Virology
  • Tetanus
  • Prospective Studies
  • Pregnancy
  • Middle Aged
  • Humans
  • Female
  • Diphtheria-Tetanus-acellular Pertussis Vaccines
 

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Fortner, K. B., Swamy, G. K., Broder, K. R., Jimenez-Truque, N., Zhu, Y., Moro, P. L., … Edwards, K. M. (2018). Reactogenicity and immunogenicity of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant and nonpregnant women. Vaccine, 36(42), 6354–6360. https://doi.org/10.1016/j.vaccine.2018.07.012
Fortner, Kimberly B., Geeta K. Swamy, Karen R. Broder, Natalia Jimenez-Truque, Yuwei Zhu, Pedro L. Moro, Jennifer Liang, et al. “Reactogenicity and immunogenicity of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant and nonpregnant women.Vaccine 36, no. 42 (October 8, 2018): 6354–60. https://doi.org/10.1016/j.vaccine.2018.07.012.
Fortner KB, Swamy GK, Broder KR, Jimenez-Truque N, Zhu Y, Moro PL, et al. Reactogenicity and immunogenicity of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant and nonpregnant women. Vaccine. 2018 Oct 8;36(42):6354–60.
Fortner, Kimberly B., et al. “Reactogenicity and immunogenicity of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant and nonpregnant women.Vaccine, vol. 36, no. 42, Oct. 2018, pp. 6354–60. Pubmed, doi:10.1016/j.vaccine.2018.07.012.
Fortner KB, Swamy GK, Broder KR, Jimenez-Truque N, Zhu Y, Moro PL, Liang J, Walter EB, Heine RP, Moody MA, Yoder S, Edwards KM. Reactogenicity and immunogenicity of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant and nonpregnant women. Vaccine. 2018 Oct 8;36(42):6354–6360.
Journal cover image

Published In

Vaccine

DOI

EISSN

1873-2518

Publication Date

October 8, 2018

Volume

36

Issue

42

Start / End Page

6354 / 6360

Location

Netherlands

Related Subject Headings

  • Young Adult
  • Whooping Cough
  • Virology
  • Tetanus
  • Prospective Studies
  • Pregnancy
  • Middle Aged
  • Humans
  • Female
  • Diphtheria-Tetanus-acellular Pertussis Vaccines