Vitali Pool1, Antigona Tomovici2, David R Johnson3, David P Greenberg4, Michael D Decker5. 1. Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370, USA. Electronic address: vitali.pool@sanofi.com. 2. Sanofi Pasteur Ltd, 1755 Steeles Avenue West, Toronto, Ontario M2R 3T4, Canada. Electronic address: miggi.tomovici@sanofi.com. 3. Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370, USA. Electronic address: dr.johnson@sanofi.com. 4. Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370, USA; Department of Pediatrics, University of Pittsburgh School of Medicine, 3550 Terrace St., Pittsburgh, PA 15213, USA. Electronic address: david.greenberg@sanofi.com. 5. Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370, USA; Vanderbilt University School of Medicine, Nashville, TN 37203, USA. Electronic address: sp@mdd1.org.
Abstract
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 1152Td 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 clinicaltrials.gov number NCT01439165.
RCT Entities:
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 clinicaltrials.gov number NCT01439165.
Authors: Pauline Versteegen; Guy A M Berbers; Gaby Smits; Elisabeth A M Sanders; Fiona R M van der Klis; Hester E de Melker; Nicoline A T van der Maas Journal: Lancet Reg Health Eur Date: 2021-09-06