Immunogenicity and reactogenicity of a decennial booster dose of a combined reduced-antigen-content diphtheria-tetanus-acellular pertussis and inactivated poliovirus booster vaccine (dTpa-IPV) in healthy adults.

Abstract

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.

• Authors: Martina Kovac, Niraj Rathi, Sherine Kuriyakose, Karin Hardt, Tino F Schwarz
• Journal: Vaccine (Vaccine) Vol. 33 Issue 22 Pg. 2594-601 (May 21 2015) ISSN: 1873-2518 [Electronic] Netherlands
• PMID: 25882172 (Publication Type: Clinical Trial, Phase IV, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Chemical References

• Antibodies, Bacterial
• Antibodies, Viral
• Boostrix
• Diphtheria Toxin
• Diphtheria-Tetanus-Pertussis Vaccine
• Diphtheria-Tetanus-acellular Pertussis Vaccines
• Poliovirus Vaccine, Inactivated
• Tetanus Toxin
• Vaccines, Combined

Topics

• Adult
• Antibodies, Bacterial (blood)
• Antibodies, Viral (blood)
• Diphtheria Toxin (immunology)
• Diphtheria-Tetanus-Pertussis Vaccine (administration & dosage, adverse effects, immunology)
• Diphtheria-Tetanus-acellular Pertussis Vaccines (administration & dosage, adverse effects, immunology)
• Female
• Follow-Up Studies
• France
• Germany
• Healthy Volunteers
• Humans
• Immunization, Secondary
• Injections, Intramuscular
• Male
• Middle Aged
• Poliovirus (immunology)
• Poliovirus Vaccine, Inactivated (administration & dosage, adverse effects, immunology)
• Tetanus Toxin
• Time Factors
• Vaccines, Combined (administration & dosage, adverse effects, immunology)