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系统性皮质类固醇治疗成人中黄热病 17D 疫苗的安全性和免疫原性:一项观察性队列研究。

Safety and immunogenicity of yellow fever 17D vaccine in adults receiving systemic corticosteroid therapy: an observational cohort study.

机构信息

Paris Descartes University, INSERM, CIC BT505, and AP-HP, Cochin Hospital, CICBT505, Paris, France.

出版信息

Arthritis Care Res (Hoboken). 2013 Sep;65(9):1522-8. doi: 10.1002/acr.22021.

Abstract

OBJECTIVE

To assess the safety and immunogenicity of live attenuated yellow fever (YF) 17D vaccine in adults receiving systemic corticosteroid therapy.

METHODS

All adult travelers on systemic corticosteroid therapy who had received the YF17D vaccine in 24 French vaccination centers were prospectively enrolled and matched with healthy controls (1:2) on age and history of YF17D immunization. Safety was assessed in a self-administered standardized questionnaire within 10 days after immunization. YF-specific neutralizing antibody titers were measured 6 months after vaccination in patients receiving corticosteroids.

RESULTS

Between July 2008 and February 2011, 102 vaccine recipients completed the safety study (34 receiving corticosteroids and 68 controls). The median age was 54.9 years (interquartile range [IQR] 45.1-60.3 years) and 45 participants had a history of previous YF17D immunization. The median time receiving corticosteroid therapy was 10 months (IQR 1-67 months) and the prednisone or equivalent dosage was 7 mg/day (IQR 5-20). Main indications were autoimmune diseases (n = 14), rheumatoid arthritis (n = 9), and upper respiratory tract infections (n = 8). No serious adverse event was reported; however, patients receiving corticosteroids reported more frequent moderate/severe local reactions than controls (12% and 2%, respectively; relative risk 8.0, 95% confidence interval 1.4-45.9). All subjects receiving corticosteroids who were tested (n = 20) had neutralizing antibody titers >10 after vaccination.

CONCLUSION

After YF17D immunization, moderate/severe local reactions may be more frequent in patients receiving systemic corticosteroid therapy. Immunogenicity seems satisfactory. Large-scale studies are needed to confirm these results.

摘要

目的

评估在接受全身皮质类固醇治疗的成年人中接种减毒活黄热病(YF)17D 疫苗的安全性和免疫原性。

方法

在 24 个法国疫苗接种中心,所有接受全身皮质类固醇治疗的旅行者均前瞻性地接受了 YF17D 疫苗接种,并根据年龄和 YF17D 免疫史与健康对照者(1:2)进行匹配。在接种后 10 天内通过自我管理的标准化问卷评估安全性。在接受皮质类固醇治疗的患者中,在接种后 6 个月测量 YF 特异性中和抗体滴度。

结果

在 2008 年 7 月至 2011 年 2 月之间,有 102 名疫苗接种者完成了安全性研究(34 名接受皮质类固醇治疗,68 名对照)。中位年龄为 54.9 岁(四分位间距 [IQR] 45.1-60.3 岁),45 名参与者有 YF17D 免疫史。接受皮质类固醇治疗的中位时间为 10 个月(IQR 1-67 个月),泼尼松龙或等效剂量为 7mg/天(IQR 5-20)。主要适应症为自身免疫性疾病(n=14)、类风湿关节炎(n=9)和上呼吸道感染(n=8)。未报告严重不良事件;然而,接受皮质类固醇治疗的患者报告的中度/重度局部反应发生率高于对照组(分别为 12%和 2%;相对风险 8.0,95%置信区间 1.4-45.9)。所有接受皮质类固醇治疗且接受检测的受试者(n=20)在接种后均具有>10 的中和抗体滴度。

结论

在接种 YF17D 后,接受全身皮质类固醇治疗的患者可能会出现更频繁的中度/重度局部反应。免疫原性似乎令人满意。需要开展大规模研究来证实这些结果。

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