Key result
Decennial dTpa-IPV booster achieves ~100% seroprotection against tetanus and polio at one month.
Why the study?
Pertussis in adults and adolescents could be reduced by replacing traditional Td boosters with reduced-antigen-content dTpa vaccines, but immunogenicity and reactogenicity data for decennial dTpa-IPV boosters were needed.
Does a decennial booster dose of dTpa-IPV improve immunogenicity and maintain safety in healthy adults who received a similar booster 10 years prior?
Does a decennial booster dose of dTpa-IPV improve immunogenicity and maintain safety in healthy adults who received a similar booster 10 years prior?
A decennial booster dose of dTpa-IPV is highly immunogenic and well tolerated in adults, supporting its repeated administration every 10 years.
Supports decennial dTpa-IPV boosting in healthy adults; leaves open durability, clinical protection, and broader applicability.
BACKGROUND: Pertussis in adults and adolescents could be reduced by replacing traditional tetanus and diphtheria (Td) boosters with reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccines. This study evaluated the administration of dTpa-IPV (dTpa-inactivated poliovirus) in adults ten years after they received a booster dose of either dTpa-IPV, dTpa+IPV or Td-IPV in trial NCT01277705. METHODS: Open multicentre, phase IV study (www.clinicaltrials.govNCT01323959) in which healthy adults, who had received a previous dose of dTpa-IPV, dTpa+IPV or Td-IPV ten years earlier, received a single decennial booster dose of dTpa-IPV (Boostrix-polio, GlaxoSmithKline Vaccines). Blood samples were collected before and one month after booster vaccination. Antibody concentrations against all vaccine antigens were measured and reactogenicity and safety were assessed. RESULTS: A total of 211 subjects (mean age 50.3 years) received vaccination of whom 201 were included in the according-to-protocol cohort for immunogenicity. Before the decennial dTpa-IPV booster, ≥71.0% subjects were seroprotected/seropositive against all vaccine antigens. One month after the booster dose, all subjects were seroprotected against tetanus and poliovirus types 2 and 3; ≥95.7% subjects were seroprotected against diphtheria and ≥98.3% against poliovirus type 1. Anti-pertussis booster responses for the various antigens were observed in ≥76.5% (pertussis toxoid; PT), ≥85.1% (filamentous haemagglutinin; FHA) and ≥63.2% (pertactin; PRN) of subjects. During the 4-day follow-up, the overall incidence of local AEs was 71.6%, 75.0% and 72.2% in dTpa-IPV, dTpa+IPV and Td-IPV groups, respectively. Pain was the most frequent solicited local adverse event (AE; ≥62.7% subjects) and fatigue the most frequent solicited general AE (≥18.5%). No serious AEs were reported during the study. CONCLUSION: A booster dose of dTpa-IPV was immunogenic and well tolerated in adults who had received a booster dose of either dTpa-IPV, dTpa+IPV or Td-IPV, ten years previously and supports the repeated administration of dTpa-IPV.
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Kovac et al. (2015) studied Healthy adults (n=211). dTpa-IPV booster vaccine was evaluated on Seroprotection against tetanus and poliovirus types 2 and 3 at one month. A decennial booster dose of dTpa-IPV in healthy adults achieved 100% seroprotection against tetanus and poliovirus types 2 and 3, and ≥95.7% against diphtheria at one month.
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