Vandermeulen Corinne, Theeten Heidi, Rathi Niraj, Kuriyakose Sherine, Han Htay Htay, Sokal Etienne, Hoppenbrouwers Karel, Van Damme Pierre
KU Leuven, University of Leuven, Centre for Environment and Health, Youth Health Care Leuven, Belgium.
Centre for the Evaluation of Vaccinations, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium.
Vaccine. 2015 Jun 12;33(26):3026-34. doi: 10.1016/j.vaccine.2014.10.049. Epub 2015 Jan 19.
Regular booster vaccination might be necessary throughout life to protect against pertussis infection. Nevertheless the duration of protection after booster vaccination remains unclear. In this study, antibody persistence up to 10 years after previous vaccination of adolescents (N=478) with combined reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine (dTpa, Boostrix™, GlaxoSmithKline Belgium) containing 0.5mg, 0.3mg or 0.133mg of aluminium was assessed. The immunogenicity, reactogenicity and safety of a decennial booster dTpa dose were also investigated.
Young adults vaccinated as adolescents in the initial booster study were invited to participate in an assessment of antibody persistence at years 8.5 and 10, and to receive a dTpa booster dose at year 10 with immunogenicity assessment one month later. Those who originally received the 0.5mg or 0.3mg formulations received the same vaccine at year 10. Those in the 0.133mg group received the 0.5mg formulation. Reactogenicity and safety endpoints were captured until 30 days after booster vaccination.
Prior to the decennial booster at year 8.5 and year 10, all participants had seroprotective antibodies for diphtheria (ELISA or neutralisation assay) and tetanus. At least 77.8% were seropositive for anti-pertussis toxin (PT) antibodies at year 8.5 and 82.8% at year 10. All participants were seropositive for antibodies for filamentous haemagglutinin and pertactin at both time points. The decennial booster dose induced robust increases in antibody GMCs to all antigens. The post-booster anti-PT geometric mean concentration was 82.5EL.U/ml (95%CI 67.0-101.6) and 124.0 (103.5-148.5) in the 0.3mg and 0.5mg groups, respectively. The reactogenicity and safety profile of the decennial booster dose was consistent with the known safety profile of dTpa. No serious adverse events were reported.
Decennial booster vaccination with either of the two licensed formulations of dTpa was highly immunogenic and well tolerated in young adults. Either formulation could be confidently used as a decennial booster. This study is registered at www.clinicaltrials.govNCT01147900.
可能终生都需要定期进行加强免疫接种以预防百日咳感染。然而，加强免疫接种后的保护持续时间仍不明确。在本研究中，评估了478名青少年先前接种含0.5mg、0.3mg或0.133mg铝的联合低抗原含量白喉-破伤风-无细胞百日咳疫苗（dTpa，博思rix™，葛兰素史克比利时公司）后长达10年的抗体持久性。还研究了十年期加强剂量dTpa的免疫原性、反应原性和安全性。
邀请在初始加强免疫研究中作为青少年接种疫苗的年轻成年人参加8.5年和10年时的抗体持久性评估，并在10年时接受一剂dTpa加强剂量，一个月后进行免疫原性评估。最初接受0.5mg或0.3mg制剂的人在10年时接种相同疫苗。0.133mg组的人接受0.5mg制剂。在加强免疫接种后30天内记录反应原性和安全性终点。
在8.5年和10年进行十年期加强免疫之前，所有参与者对白喉（酶联免疫吸附测定或中和试验）和破伤风均具有血清保护性抗体。在8.5年时，至少77.8%的人抗百日咳毒素（PT）抗体呈血清阳性，在10年时为82.8%。在两个时间点，所有参与者丝状血凝素和百日咳杆菌粘附素抗体均呈血清阳性。十年期加强剂量使所有抗原的抗体几何平均浓度（GMCs）显著增加。在0.3mg和0.5mg组中，加强免疫后抗PT几何平均浓度分别为82.5EL.U/ml（95%置信区间67.0-101.6）和124.0（103.5-148.5）。十年期加强剂量的反应原性和安全性与已知的dTpa安全性特征一致。未报告严重不良事件。
两种已获许可的dTpa制剂进行十年期加强免疫接种在年轻成年人中具有高度免疫原性且耐受性良好。任何一种制剂都可放心用作十年期加强疫苗。本研究已在www.clinicaltrials.gov注册，注册号为NCT01147900。
