a GSK, Vaccines, Wavre , Belgium.
b XPE Pharma & Science , Wavre , Belgium, Belgium.
Hum Vaccin Immunother. 2018;14(8):1977-1986. doi: 10.1080/21645515.2018.1460292. Epub 2018 May 10.
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.
百日咳是一种高度传染性疾病，在过去几十年中，其发病率呈周期性高峰，暴发次数也不断增加。含低抗原成分的破伤风-白喉-无细胞百日咳疫苗（Tdap）可用于增强在婴儿期接种过白喉-破伤风-无细胞百日咳疫苗（DTaP）的年龄≥10 岁人群的免疫力，以降低百日咳发病率，并在青少年和成年期保持对白喉和破伤风的保护。这项 III 期、开放性、非随机、多中心随访研究（NCT01738477）纳入了来自美国的 19-30 岁参与者，他们在 10 年前接受了 Tdap（Tdap 组）或 Td（Td 组）的加强免疫接种。共有 128 名（Tdap 组）和 37 名（Td 组）参与者接受了 Tdap 疫苗接种。接种 Tdap 后，所有参与者均对破伤风和白喉产生了血清保护（抗体浓度≥0.1 国际单位[IU]/ml）。Tdap 组接受第二剂 Tdap 后的免疫应答与 Td 组第一剂 Tdap 后的免疫应答以及婴儿期接受 3 剂 DTaP 疫苗接种后对百日咳抗原的免疫应答相当（主要终点）。加强免疫后，两组所有参与者的抗体浓度均高于检测截止值，与加强免疫前相比，所有抗原的抗体几何平均浓度均增加了 3.8-15.5 倍。Td（80.6%）和 Tdap（85.6%）组的不良事件发生率相似（无严重不良事件报告）。先前接种过 Td 或 Tdap 疫苗后接种 Tdap 疫苗具有免疫原性且耐受性良好，支持每隔 10 年重复接种 Tdap。
