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Treatment with the IL-17 blocking antibody secukinumab (AIN457) does not interfere with the efficacy of Influenza and Meningococcal vaccination in healthy subjects. Results of an open-label, parallel group, randomized, single-center study

Chioato, Andrea and Noseda, Emanuele and Stevens, Michael and Gaitatzis, Nikolaos and Kleinschmidt, Annett and Picaud, Henri (2012) Treatment with the IL-17 blocking antibody secukinumab (AIN457) does not interfere with the efficacy of Influenza and Meningococcal vaccination in healthy subjects. Results of an open-label, parallel group, randomized, single-center study. Clinical and Vaccine Immunology (CVI), 19 (10). pp. 1597-1602. ISSN 1556-6811

Abstract

Objectives: to evaluate the efficacy of influenza and meningococcal vaccinations in healthy subjects exposed to the anti-IL-1 mAb secukinumab.
Methods: open-label, parallel groups, randomized single-center study in 50 healthy subjects. Subjects received a single secukinumab (AIN457) 150 mg s.c. dose or no treatment, followed by influenza and meningococcal vaccinations two weeks later. Primary efficacy variables: responses to vaccinations as ≥4-fold increase in Ab titer in ≥2/3 serotypes (influenza) and ≥4-fold increase (meningococcus), both at 4 weeks post-vaccination. Immunogenicity was assesed as hemagglutination inhibition (HI, influenza) and Serum Bactericidal Assay (SBA, Neisseria meningitidis).
Results: all 50 subjects, randomized to secukinumab (n=25) or control (n=25) completed the study. Antibody responses to vaccinations measured at four weeks post-vaccination were comparable in both groups, with responses following influenza vaccine of 20/25(80%) for both groups and following MenC vaccine of 19/25(76%) for secukinumab and 18/25(72%) for control. The differences between groups were 0% (90% CI -19%,19%) and 4% (90% CI -16%,24%) for influenza and MenC vaccines respectively. Antibody responses were also comparable in the two groups at different time-points assessed. Headache was the most frequently reported adverse event. No deaths or serious adverse events were reported during the study.
Conclusions: Blockade of IL-17 by secukinumab (AIN457) does not appear to interfere with the efficacy of influenza and meningococcal vaccinations, as assessed by the achievement of antibody protective 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 control, respectively.

Item Type: Article
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Keywords: Autoimmune diseases, secukinumab, influenza, meningococcus, vaccine, monoclonal antibodies, AIN457, IL-17
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Date Deposited: 13 Oct 2015 13:15
Last Modified: 13 Oct 2015 13:15
URI: https://oak.novartis.com/id/eprint/5374

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