Tags

Type your tag names separated by a space and hit enter

Immunogenicity and safety of a second booster dose of an acellular pertussis vaccine combined with reduced antigen content diphtheria-tetanus toxoids 10 years after a first booster in adolescence: An open, phase III, non-randomized, multi-center study.
Hum Vaccin Immunother. 2018; 14(8):1977-1986.HV

Abstract

Pertussis is a highly contagious disease, for which periodic peaks in incidence and an increasing number of outbreaks have been observed over the last decades. The reduced-antigen-content tetanus-diphtheria-acellular pertussis vaccine (Tdap) can be used to boost individuals aged ≥10 years, vaccinated in infancy with a diphtheria-tetanus-acellular pertussis vaccine (DTaP), to reduce pertussis morbidity and maintain protection against diphtheria and tetanus throughout adolescence and adulthood. This phase III, open-label, non-randomized, multicenter follow-up study (NCT01738477) enrolled 19-30-year-old participants from the United States who had received booster vaccination 10 years earlier with either Tdap (Tdap group) or Td (Td group). In total, 128 (Tdap group) and 37 (Td group) participants received Tdap vaccination. After administration of Tdap, all participants were seroprotected (antibody concentrations ≥0.1 international units [IU]/ml) against diphtheria and tetanus. Immune responses to a second Tdap dose in the Tdap group were shown to be non-inferior to responses elicited by a first Tdap dose in the Td group for diphtheria and tetanus and to a 3-dose DTaP vaccination during infancy for pertussis antigens (primary objectives). Post-booster vaccination, all participants in both groups had antibody concentrations above assay cut-offs and antibody geometric mean concentrations increased by 3.8-15.5-fold compared to pre-booster levels for all antigens. The incidence of adverse events was similar in the Td (80.6%) and Tdap (85.6%) groups (no serious adverse events reported). A Tdap dose administered after previous Td or Tdap vaccination was shown to be immunogenic and well-tolerated in young adults, supporting repeated vaccination with Tdap at 10-year intervals.

Authors+Show Affiliations

a GSK, Vaccines, Wavre , Belgium.b XPE Pharma & Science , Wavre , Belgium, Belgium.a GSK, Vaccines, Wavre , Belgium.c GSK Vaccines , Bangalore , India.d Pediatric Infectious Disease, Creighton University , Omaha , NE , United States.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29630439

Citation

Kovac, Martina, et al. "Immunogenicity and Safety of a Second Booster Dose of an Acellular Pertussis Vaccine Combined With Reduced Antigen Content Diphtheria-tetanus Toxoids 10 Years After a First Booster in Adolescence: an Open, Phase III, Non-randomized, Multi-center Study." Human Vaccines & Immunotherapeutics, vol. 14, no. 8, 2018, pp. 1977-1986.
Kovac M, Kostanyan L, Mesaros N, et al. Immunogenicity and safety of a second booster dose of an acellular pertussis vaccine combined with reduced antigen content diphtheria-tetanus toxoids 10 years after a first booster in adolescence: An open, phase III, non-randomized, multi-center study. Hum Vaccin Immunother. 2018;14(8):1977-1986.
Kovac, M., Kostanyan, L., Mesaros, N., Kuriyakose, S., & Varman, M. (2018). Immunogenicity and safety of a second booster dose of an acellular pertussis vaccine combined with reduced antigen content diphtheria-tetanus toxoids 10 years after a first booster in adolescence: An open, phase III, non-randomized, multi-center study. Human Vaccines & Immunotherapeutics, 14(8), 1977-1986. https://doi.org/10.1080/21645515.2018.1460292
Kovac M, et al. Immunogenicity and Safety of a Second Booster Dose of an Acellular Pertussis Vaccine Combined With Reduced Antigen Content Diphtheria-tetanus Toxoids 10 Years After a First Booster in Adolescence: an Open, Phase III, Non-randomized, Multi-center Study. Hum Vaccin Immunother. 2018;14(8):1977-1986. PubMed PMID: 29630439.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and safety of a second booster dose of an acellular pertussis vaccine combined with reduced antigen content diphtheria-tetanus toxoids 10 years after a first booster in adolescence: An open, phase III, non-randomized, multi-center study. AU - Kovac,Martina, AU - Kostanyan,Lusiné, AU - Mesaros,Narcisa, AU - Kuriyakose,Sherine, AU - Varman,Meera, Y1 - 2018/05/10/ PY - 2018/4/10/pubmed PY - 2019/4/30/medline PY - 2018/4/10/entrez KW - decennial booster KW - diphtheria KW - pertussis KW - tetanus KW - vaccination SP - 1977 EP - 1986 JF - Human vaccines & immunotherapeutics JO - Hum Vaccin Immunother VL - 14 IS - 8 N2 - Pertussis is a highly contagious disease, for which periodic peaks in incidence and an increasing number of outbreaks have been observed over the last decades. The reduced-antigen-content tetanus-diphtheria-acellular pertussis vaccine (Tdap) can be used to boost individuals aged ≥10 years, vaccinated in infancy with a diphtheria-tetanus-acellular pertussis vaccine (DTaP), to reduce pertussis morbidity and maintain protection against diphtheria and tetanus throughout adolescence and adulthood. This phase III, open-label, non-randomized, multicenter follow-up study (NCT01738477) enrolled 19-30-year-old participants from the United States who had received booster vaccination 10 years earlier with either Tdap (Tdap group) or Td (Td group). In total, 128 (Tdap group) and 37 (Td group) participants received Tdap vaccination. After administration of Tdap, all participants were seroprotected (antibody concentrations ≥0.1 international units [IU]/ml) against diphtheria and tetanus. Immune responses to a second Tdap dose in the Tdap group were shown to be non-inferior to responses elicited by a first Tdap dose in the Td group for diphtheria and tetanus and to a 3-dose DTaP vaccination during infancy for pertussis antigens (primary objectives). Post-booster vaccination, all participants in both groups had antibody concentrations above assay cut-offs and antibody geometric mean concentrations increased by 3.8-15.5-fold compared to pre-booster levels for all antigens. The incidence of adverse events was similar in the Td (80.6%) and Tdap (85.6%) groups (no serious adverse events reported). A Tdap dose administered after previous Td or Tdap vaccination was shown to be immunogenic and well-tolerated in young adults, supporting repeated vaccination with Tdap at 10-year intervals. SN - 2164-554X UR - https://www.unboundmedicine.com/medline/citation/29630439/Immunogenicity_and_safety_of_a_second_booster_dose_of_an_acellular_pertussis_vaccine_combined_with_reduced_antigen_content_diphtheria_tetanus_toxoids_10_years_after_a_first_booster_in_adolescence:_An_open_phase_III_non_randomized_multi_center_study_ L2 - https://www.tandfonline.com/doi/full/10.1080/21645515.2018.1460292 DB - PRIME DP - Unbound Medicine ER -