Treatment with the Interleukin-17A-Blocking Antibody Secukinumab Does Not Interfere with the Efficacy of Influenza and Meningococcal Vaccinations in Healthy Subjects: Results of an Open-Label, Parallel-Group, Randomized Single-Center Study

被引:53
作者
Chioato, A. [1 ]
Noseda, E. [1 ]
Stevens, M. [2 ]
Gaitatzis, N. [3 ]
Kleinschmidt, A. [3 ]
Picaud, H. [4 ]
机构
[1] Novartis Inst Biomed Res, Basel, Switzerland
[2] EMStat Ltd, Leicester, Leics, England
[3] Novartis Vaccines & Diagnost, Marburg, Germany
[4] MEDISCIS, Poitiers, France
关键词
RHEUMATOID-ARTHRITIS;
D O I
10.1128/CVI.00386-12
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Our objective was to evaluate the efficacy of influenza and meningococcal vaccinations in healthy subjects exposed to the anti-interleukin-17A (IL-17A) monoclonal antibody (MAb) secukinumab. We used an open-label, parallel-group, randomized single-center study of 50 healthy subjects. Subjects received a single 150-mg dose of secukinumab or no treatment, followed by vaccination with inactivated trivalent subunit influenza virus and conjugate group C meningococcal vaccine (Agrippal and Menjugate, respectively) 2 weeks later. Primary efficacy variables were responses of >= 4-fold increases in antibody titer (hemagglutination inhibition [HI; for influenza virus] and serum bactericidal assay [SBA; for Neisseria meningitides]) for meningococcus and influenza (at least two out of three serotypes), both at 4 weeks postvaccination. All subjects randomized to secukinumab (n = 25) or the control (n = 25) completed the study. Antibody responses to vaccinations measured at 4 weeks were comparable in both groups, with >= 4-fold increased responses following influenza virus vaccination of 20/25 (80%) for both groups and following meningococcal vaccination of 19/25 (76%) for the secukinumab group and 18/25 (72%) for the control group. Differences between groups were 0% (90% confidence intervals [CI], 19 and 19%) and 4% (90% CI, 16 and 24%) for influenza virus and meningococcal vaccines, respectively. Antibody responses were comparable between the 2 groups at different time points. Headache was the most frequently reported adverse effect. No deaths or serious adverse events were reported. Blockade of IL-17A by secukinumab does not appear to interfere with efficacy of influenza and meningococcal vaccinations, as assessed by the achievement of protective antibody levels. A protective (>= 4-fold) immune response to both vaccinations at 4 weeks was achieved in 80 and 76% of subjects exposed to secukinumab and the control, respectively.
引用
收藏
页码:1597 / 1602
页数:6
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