Humoral immunity 10 years after booster immunization with an adolescent and adult formulation combined tetanus, diphtheria, and 5-component acellular pertussis vaccine in the USA

Vaccine. 2018 Apr 19;36(17):2282-2287. doi: 10.1016/j.vaccine.2018.03.029. Epub 2018 Mar 21.


Background: In a prospective, randomized pivotal phase III clinical trial, the immunogenicity and reactogenicity of a tetanus-diphtheria-acellular pertussis vaccine (Tdap) and a tetanus-diphtheria vaccine (Td) vaccine were studied in participants aged 11-64 years. Here we report antibody persistence through 10 years after vaccination.

Methods: Participants who received Tdap or Td in the original phase III trial and provided pre- and post-vaccination serum samples were recruited to donate sera at 1, 3, 5 and 10 years post-vaccination. Antibody concentrations were measured using standard assay techniques.

Results: Initially, 1457 Tdap and 1152 Td recipients were included; of these, 175 persons from Tdap group were available at the final study bleed point. Nearly all adolescents in both groups had diphtheria antibody levels ≥0.1 IU/mL 1 month after vaccination, which were maintained in ≥95% of vaccinees at 5 and 10 years. Among adults, ≥94% had diphtheria antibody levels ≥0.1 IU/mL 1 month after vaccination, which were maintained in ≥80% at 5 and 10 years. Nearly all participants had tetanus antibodies ≥0.1 IU/mL throughout the study. PT antibodies declined to pre-vaccination levels approximately 5 years post-vaccination; FHA, PRN and FIM antibodies waned at 5 and 10 years but remained several-fold higher than pre-vaccination levels.

Conclusions: Tdap and Td provide long-lasting protective immune responses against diphtheria and tetanus. Pertussis antibodies following Tdap generally exceeded pre-vaccination levels throughout the study, but showed substantial waning. These data may inform discussion of the need for repeat Tdap booster vaccinations among adults.

Trial registration: The original phase III clinical trial, as well as the 1-, 3-, and 5-year serology follow-up studies were conducted prior to mandatory registration. The 10-year serology follow-up data collection was performed as part of a repeat Tdap administration clinical trial that was registered under number NCT01439165.

Keywords: Antibody persistence; Diphtheria; Pertussis; Tetanus.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Antibodies, Bacterial / immunology
  • Child
  • Clinical Trials, Phase III as Topic
  • Diphtheria-Tetanus Vaccine / immunology*
  • Diphtheria-Tetanus-acellular Pertussis Vaccines / immunology*
  • Follow-Up Studies
  • Humans
  • Immunity, Humoral / immunology*
  • Immunization, Secondary / methods
  • Male
  • Middle Aged
  • Prospective Studies
  • Randomized Controlled Trials as Topic
  • Tetanus / immunology
  • Tetanus / prevention & control
  • Vaccination / methods
  • Vaccines, Combined / immunology*
  • Whooping Cough / immunology
  • Whooping Cough / prevention & control
  • Young Adult


  • Antibodies, Bacterial
  • Diphtheria-Tetanus Vaccine
  • Diphtheria-Tetanus-acellular Pertussis Vaccines
  • Vaccines, Combined

Associated data