Randomized controlled trial of the safety and immunogenicity of revaccination with tetanus-diphtheria-acellular pertussis vaccine (TDAP) in adults 10 years after a previous dose

Scott A. Halperin, Catherine Donovan, Gary S. Marshall, Vitali Pool, Michael D. Decker, David R. Johnson, David P. Greenberg, Gerald Bader, Stuart Weisman, Ambaram Chauhan, Kenneth Bromberg, Michael McGuire, Martin L. Kabongo, Matthew Hall, Leonard Weiner, Peter Silas, Daniel Brune, Tim Craig, Marion Michaels, Edwin AndersonSusan Keathley, Kevin Rouse, Joseph Leader, Laura Helman, Wilson Andrews, David Bernstein, Randall Middleton, Mahashweta Ghosh, Douglas Mitchell, Shelly Senders, Wilson Andrews, David Wyszomierski, David Allison

Research output: Contribution to journalArticlepeer-review

14 Scopus citations

Abstract

Background. Reduced-antigen-content tetanus, diphtheria, and acellular pertussis (Tdap) vaccine is recommended in many countries for boosting immunity in adolescents and adults. Although immunity to these antigens wanes with time, currently available Tdap products are not labeled for repeat administration in the United States. Methods. We performed an observer-blinded, randomized controlled trial in 1330 adults aged 18 to <65 years who received either the Tdap (n = 1002) or tetanus-diphtheria (Td) (n = 328) vaccine 8 to 12 years after a dose of Tdap vaccine administered previously. Solicited adverse events following immunization were documented for 7 days after vaccination, and serious adverse events and adverse events of medical significance were documented for 6 months after vaccination. Levels of antibodies against component vaccine antigens were measured before and 1 month after vaccination. Results. A solicited adverse event was reported by 87.7% of Tdap and 88.0% of Td vaccine recipients. We found no significant differences in the rates of injection-site reactions, systemic reactions, or serious adverse events between the vaccine groups. A robust antibody response to each pertussis antigen in the Tdap-vaccinated group was found; postvaccination-to-prevaccination geometric mean antibody concentration ratios were 8:1 (pertussis toxoid), 5.9 (filamentous hemagglutinin), 6.4 (pertactin), and 5.2 (fimbriae 2 and 3). Postvaccination geometric mean concentrations of tetanus antibody (4.20 and 4.74 IU/mL, respectively) and diphtheria antibody (10.1 and 12.6 IU/mL, respectively) were similar in the Tdap and Td groups, and the rates of seroprotection against tetanus and diphtheria were >99% in both groups. Conclusions. A second dose of Tdap vaccine in adults approximately 10 years after a previous dose was well tolerated and immunogenic. These data might facilitate consideration of providing Tdap booster doses to adults.

Original languageEnglish
Pages (from-to)105-114
Number of pages10
JournalJournal of the Pediatric Infectious Diseases Society
Volume8
Issue number2
DOIs
StatePublished - 11 May 2019
Externally publishedYes

Keywords

  • Acellular pertussis vaccine
  • Booster
  • Diphtheria
  • Pertussis
  • Tdap
  • Tetanus

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