tetano
Editor, Senior Moderator
Clin Vaccine Immunol. 2012 Aug 8. [Epub ahead of print]
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.
Chioato A, Noseda E, Stevens M, Gaitatzis N, Kleinschmidt A, Picaud H.
Source
Novartis Institutes for Biomedical Research, Basel, Switzerland.
Abstract
Objective: To evaluate the efficacy of influenza and meningococcal vaccinations in healthy subjects exposed to anti-interleukin (IL)-17A monoclonal Antibody (mAb) secukinumab.Methods: Open-label, parallel-group, randomized single-center study in 50 healthy subjects. Subjects received a single secukinumab 150 mg dose or no treatment, followed by vaccination with inactivated trivalent subunit influenza and conjugate group C meningococcal vaccine (Agrippal? and Menjugate?,) 2-weeks later. Primary efficacy variables: responses as ≥4-fold increase in antibody titer (hemagglutination inhibition [HI, influenza] and serum bactericidal assay [SBA, Neisseria meningitides]) for meningococcus and influenza (≥2/3 serotypes), both at 4 weeks post-vaccination.Results: All subjects randomized to secukinumab (n=25) or control (n=25) completed the study. Antibody responses to vaccinations measured at 4-weeks were comparable in both groups, with greater than or equal to 4-fold responses following influenza vaccine of 20/25 (80%) for both groups and following meningococcal vaccine of 19/25 (76%) for secukinumab group and 18/25 (72%) for control. Differences between groups were 0% (90% CI: 19%, 19%) and 4% (90% CI: 16%, 24%) for influenza and meningococcal vaccines, respectively. Antibody responses were comparable in the 2 groups at different time points. Headache was the most frequently reported AE. No deaths or SAEs were reported.Conclusions: 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 control, respectively.
PMID:
22875601
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/22875601
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.
Chioato A, Noseda E, Stevens M, Gaitatzis N, Kleinschmidt A, Picaud H.
Source
Novartis Institutes for Biomedical Research, Basel, Switzerland.
Abstract
Objective: To evaluate the efficacy of influenza and meningococcal vaccinations in healthy subjects exposed to anti-interleukin (IL)-17A monoclonal Antibody (mAb) secukinumab.Methods: Open-label, parallel-group, randomized single-center study in 50 healthy subjects. Subjects received a single secukinumab 150 mg dose or no treatment, followed by vaccination with inactivated trivalent subunit influenza and conjugate group C meningococcal vaccine (Agrippal? and Menjugate?,) 2-weeks later. Primary efficacy variables: responses as ≥4-fold increase in antibody titer (hemagglutination inhibition [HI, influenza] and serum bactericidal assay [SBA, Neisseria meningitides]) for meningococcus and influenza (≥2/3 serotypes), both at 4 weeks post-vaccination.Results: All subjects randomized to secukinumab (n=25) or control (n=25) completed the study. Antibody responses to vaccinations measured at 4-weeks were comparable in both groups, with greater than or equal to 4-fold responses following influenza vaccine of 20/25 (80%) for both groups and following meningococcal vaccine of 19/25 (76%) for secukinumab group and 18/25 (72%) for control. Differences between groups were 0% (90% CI: 19%, 19%) and 4% (90% CI: 16%, 24%) for influenza and meningococcal vaccines, respectively. Antibody responses were comparable in the 2 groups at different time points. Headache was the most frequently reported AE. No deaths or SAEs were reported.Conclusions: 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 control, respectively.
PMID:
22875601
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/22875601