title: Immunogenicity, safety, and antibody persistence at 3, 5, and 10 years postvaccination in adolescents randomized to booster immunization with a combined tetanus, diphtheria, 5-component acellular pertussis, and inactivated poliomyelitis vaccine administered with a hepatitis B virus vaccine concurrently or 1 month apart.
abstract: An understanding of the antibody persistence elicited by a combined tetanus, diphtheria, 5-component acellular pertussis, and inactivated poliovirus vaccine (Tdap-IPV) after adolescent vaccination is important to optimize booster dosing intervals. Our objectives were to compare the safety and immunogenicity of Tdap-IPV coadministered with hepatitis B vaccine (HepB) and sequential administration and evaluate humoral immunity at 3, 5, and 10 years after Tdap-IPV vaccination in adolescents. This phase II randomized, controlled, and open-label study enrolled 280 11- to 14-year-old adolescents with up to 10 years postvaccination follow-up. Group 1 (n = 145) received Tdap-IPV, followed by a HepB dose 1 month later, and group 2 (n = 135) received both vaccines simultaneously. No consistent increases in solicited reactions or unsolicited adverse events occurred with coadministration. All vaccinees attained seroprotective antibody levels at ≥0.01 IU/ml for diphtheria and tetanus, at a ≥1:8 dilution for poliovirus (serotypes 1, 2, and 3), and ≥10 mIU/ml for hepatitis B at 1 month postvaccination. Clinically relevant immunologic interactions did not occur with coadministration. For pertussis, all participants achieved seropositivity levels (at or above the lower limit of quantitation), and 72.7% to 95.8% had 4-fold increases in pertussis antibodies at 1 month postvaccination. At 10 years postvaccination, the remaining participants (62.8% of the original cohort) maintained seroprotective levels of ≥0.01 IU/ml for diphtheria and tetanus, a ≥1:8 dilution for all 3 poliovirus serotypes, and 74.1% to 98.2% maintained pertussis seropositivity levels depending on the antigen tested. There were no differences between the groups. These results support the coadministration of Tdap-IPV and HepB to adolescents and suggest that vaccination with Tdap-IPV can offer protection for 10 years after an adolescent booster vaccination.
authors.affiliation: University of Manitoba, Winnipeg, Manitoba, Canada.
authors.forename: Joanne
authors.initials: J
authors.lastname: Embree
authors.affiliation: University of Manitoba, Winnipeg, Manitoba, Canada.
authors.forename: Barbara
authors.initials: B
authors.lastname: Law
authors.affiliation: Sanofi Pasteur, Swiftwater, Pennsylvania, USA.
authors.forename: Tim
authors.initials: T
authors.lastname: Voloshen
authors.affiliation: Sanofi Pasteur, Toronto, Ontario, Canada miggi.tomovici@sanofipasteur.com.
authors.forename: Antigona
authors.initials: A
authors.lastname: Tomovici
mesh_terms: D000293:Adolescent; D000907:Antibodies, Bacterial / Q000097:blood / Q000276:immunology; D000914:Antibodies, Viral / Q000097:blood / Q000276:immunology; D004165:Diphtheria / Q000276:immunology / Q000517:prevention & control; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D005260:Female; D005500:Follow-Up Studies; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D006515:Hepatitis B virus / Q000276:immunology*; D006801:Humans; D056724:Immunity, Humoral; D007115:Immunization Schedule; D007117:Immunization, Secondary; D007273:Injections, Intramuscular; D008297:Male; D011051:Poliomyelitis / Q000276:immunology / Q000517:prevention & control; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D013742:Tetanus / Q000276:immunology / Q000517:prevention & control; D013997:Time Factors
chemical_list: D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D017325:Hepatitis B Vaccines; D011054:Poliovirus Vaccine, Inactivated