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: Joanne Embree, Barbara Law, Tim Voloshen, Antigona Tomovici
• Journal: Clinical and vaccine immunology : CVI (Clin Vaccine Immunol) Vol. 22 Issue 3 Pg. 282-90 (Mar 2015) ISSN: 1556-679X [Electronic] United States
• PMID: 25540274 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015, American Society for Microbiology. All Rights Reserved.

Chemical References

• Antibodies, Bacterial
• Antibodies, Viral
• Diphtheria-Tetanus-acellular Pertussis Vaccines
• Hepatitis B Vaccines
• Poliovirus Vaccine, Inactivated

Topics

• Adolescent
• Antibodies, Bacterial (blood, immunology)
• Antibodies, Viral (blood, immunology)
• Diphtheria (immunology, prevention & control)
• Diphtheria-Tetanus-acellular Pertussis Vaccines (administration & dosage, adverse effects, immunology)
• Female
• Follow-Up Studies
• Hepatitis B Vaccines (administration & dosage, adverse effects, immunology)
• Hepatitis B virus (immunology)
• Humans
• Immunity, Humoral
• Immunization Schedule
• Immunization, Secondary
• Injections, Intramuscular
• Male
• Poliomyelitis (immunology, prevention & control)
• Poliovirus Vaccine, Inactivated (administration & dosage, adverse effects, immunology)
• Tetanus (immunology, prevention & control)
• Time Factors