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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.
Kovac, Martina; Rathi, Niraj; Kuriyakose, Sherine; Hardt, Karin; Schwarz, Tino F.
Afiliación
  • Kovac M; GSK Vaccines, Wavre, Belgium.
  • Rathi N; GSK Vaccines, Bangalore, India.
  • Kuriyakose S; GSK Vaccines, Bangalore, India.
  • Hardt K; GSK Vaccines, Wavre, Belgium.
  • Schwarz TF; Central Laboratory and Vaccination Centre, Stiftung Juliusspital, Würzburg, Germany. Electronic address: t.schwarz@juliusspital.de.
Vaccine ; 33(22): 2594-601, 2015 May 21.
Article en En | MEDLINE | ID: mdl-25882172
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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vacuna Antipolio de Virus Inactivados / Vacuna contra Difteria, Tétanos y Tos Ferina / Inmunización Secundaria / Vacunas contra Difteria, Tétanos y Tos Ferina Acelular Tipo de estudio: Clinical_trials / Guideline / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Female / Humans / Male / Middle aged País/Región como asunto: Europa Idioma: En Revista: Vaccine Año: 2015 Tipo del documento: Article País de afiliación: Bélgica Pais de publicación: Países Bajos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vacuna Antipolio de Virus Inactivados / Vacuna contra Difteria, Tétanos y Tos Ferina / Inmunización Secundaria / Vacunas contra Difteria, Tétanos y Tos Ferina Acelular Tipo de estudio: Clinical_trials / Guideline / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Female / Humans / Male / Middle aged País/Región como asunto: Europa Idioma: En Revista: Vaccine Año: 2015 Tipo del documento: Article País de afiliación: Bélgica Pais de publicación: Países Bajos