Embree Joanne, Law Barbara, Voloshen Tim, Tomovici Antigona
University of Manitoba, Winnipeg, Manitoba, Canada.
Sanofi Pasteur, Swiftwater, Pennsylvania, USA.
Clin Vaccine Immunol. 2015 Mar;22(3):282-90. doi: 10.1128/CVI.00682-14. Epub 2014 Dec 24.
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.
了解青少年接种联合破伤风、白喉、五组分无细胞百日咳和灭活脊髓灰质炎病毒疫苗（Tdap-IPV）后抗体的持久性，对于优化加强免疫的给药间隔很重要。我们的目标是比较Tdap-IPV与乙型肝炎疫苗（HepB）联合接种和序贯接种的安全性和免疫原性，并评估青少年接种Tdap-IPV后3年、5年和10年的体液免疫情况。这项II期随机、对照、开放标签研究纳入了280名11至14岁的青少年，对其进行长达10年的疫苗接种后随访。第1组（n = 145）接种Tdap-IPV，1个月后接种一剂HepB，第2组（n = 135）同时接种两种疫苗。联合接种后，主动报告的反应或非预期不良事件没有持续增加。所有疫苗接种者在接种后1个月时，白喉和破伤风抗体水平均达到≥0.01 IU/ml的血清保护水平，脊髓灰质炎病毒（1、2和3型）稀释度≥1:8，乙型肝炎抗体水平≥10 mIU/ml。联合接种未发生临床相关的免疫相互作用。对于百日咳，所有参与者均达到血清阳性水平（达到或高于定量下限），72.7%至95.8%的参与者在接种后1个月时百日咳抗体增加了4倍。接种后10年，其余参与者（占原队列的62.8%）白喉和破伤风抗体水平维持在≥0.01 IU/ml的血清保护水平，所有3种脊髓灰质炎病毒血清型的稀释度≥1:8，根据检测的抗原不同，74.1%至98.2%的参与者维持百日咳血清阳性水平。两组之间没有差异。这些结果支持对青少年联合接种Tdap-IPV和HepB，并表明接种Tdap-IPV可为青少年加强免疫接种后10年提供保护。
