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在治疗阻塞性气道疾病的成年人中,降低抗原破伤风、白喉和无细胞百日咳疫苗的免疫原性和安全性。

Immunogenicity and safety of reduced-antigen tetanus, diphtheria and acellular pertussis vaccination in adults treated for obstructive airway diseases.

机构信息

GSK, Wavre, Belgium.

出版信息

Hum Vaccin Immunother. 2023 Dec 31;19(1):2159731. doi: 10.1080/21645515.2022.2159731. Epub 2023 Feb 6.

Abstract

Patients with obstructive airway diseases (OAD), like chronic obstructive pulmonary disease (COPD) and asthma, may be at increased risk of pertussis infection. Pertussis may also trigger COPD and asthma exacerbations. Vaccination against pertussis could help protect OAD patients from the additional burden of pertussis, but there may be hesitancy related to vaccine safety and immunogenicity in such patients. We performed a meta-analysis on 5 clinical trials in adults receiving reduced-antigen tetanus-diphtheria-acellular pertussis vaccine (Tdap, , GSK), from which we selected participants on active OAD treatment. We compared immunogenicity and reactogenicity outcomes of the meta-analysis with data from the overall populations of Tdap-vaccinated adults from 6 Tdap trials (including the 5 in the meta-analysis). The meta-analysis comprised 222 adults on active standard OAD treatment. One month post-Tdap, 89.0% and 97.2% of these adults, respectively, achieved seroprotective anti-diphtheria and anti-tetanus antibody concentrations; 78.3%-96.1% showed booster responses across the 3 pertussis antigens. These rates were consistent with those in the comparator population. The most frequently reported solicited local and systemic adverse events within 4 days post-Tdap were injection site pain (47.7%) and fatigue (19.3%), with low rates of grade 3 intensity (0.9% and 2.8%). This was consistent with Tdap reactogenicity in the comparator population. Evaluation of unsolicited and serious adverse events within 1 month post-Tdap did not identify safety concerns. In conclusion, Tdap was immunogenic and well tolerated in adults under active standard OAD treatment, with immunogenicity and safety profiles consistent with those in a comparator population representing the general adult population.

摘要

患有阻塞性气道疾病(OAD)的患者,如慢性阻塞性肺疾病(COPD)和哮喘,可能有更高的百日咳感染风险。百日咳也可能引发 COPD 和哮喘恶化。接种百日咳疫苗可以帮助 OAD 患者减轻百日咳的额外负担,但患者可能对疫苗安全性和免疫原性存在疑虑。我们对 5 项成人接受低抗原破伤风白喉无细胞百日咳联合疫苗(Tdap,GSK)的临床试验进行了荟萃分析,从中选择了正在接受 OAD 治疗的参与者。我们比较了荟萃分析的免疫原性和不良反应结果与 6 项 Tdap 疫苗接种成人总体人群的数据(包括荟萃分析中的 5 项)。荟萃分析包括 222 名正在接受标准 OAD 治疗的成年人。在接种 Tdap 后 1 个月,分别有 89.0%和 97.2%的成年人达到了抗白喉和破伤风抗体的保护浓度;78.3%-96.1%的成年人对 3 种百日咳抗原显示了增强反应。这些比率与对照组人群一致。接种 Tdap 后 4 天内最常报告的局部和全身不良事件是注射部位疼痛(47.7%)和疲劳(19.3%),3 级强度的不良事件发生率低(0.9%和 2.8%)。这与对照组人群的 Tdap 不良反应一致。接种 Tdap 后 1 个月内评估未报告的和严重的不良事件没有发现安全性问题。总之,在正在接受标准 OAD 治疗的成年人中,Tdap 具有免疫原性且耐受性良好,其免疫原性和安全性与代表一般成年人群的对照组人群一致。

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