Factors influencing the efficacy of two injections of a pandemic 2009 influenza A (H1N1) nonadjuvanted vaccine in systemic lupus erythematosus

Authors

  • A. Mathian,

    Corresponding author
    1. Centre de Référence National pour les Lupus et le Syndrome des Antiphospholipides, Groupement Hospitalier Pitié-Salpêtrière, AP-HP, Université Pierre et Marie Curie, Université Paris 06, and INSERM UMR-S 945, Paris, France
    • Service de Médecine Interne 2, Hôpital la Pitié-Salpêtrière, 47-83 Boulevard de l'Hôpital, 75651 Paris Cedex 13, France
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    • Drs. Mathian and Devilliers contributed equally to this work.

  • H. Devilliers,

    1. Groupement Hospitalier Pitié-Salpêtrière, AP-HP, Paris, France and Centre Hospitalier Universitaire de Dijon, Dijon, France
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    • Drs. Mathian and Devilliers contributed equally to this work.

  • A. Krivine,

    1. Groupement Hospitalier Cochin, AP-HP, Paris, France
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  • N. Costedoat-Chalumeau,

    1. Centre de Référence National pour les Lupus et le Syndrome des Antiphospholipides, Groupement Hospitalier Pitié-Salpêtrière, AP-HP, and Université Pierre et Marie Curie Université Paris 06, Paris, France
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  • J. Haroche,

    1. Centre de Référence National pour les Lupus et le Syndrome des Antiphospholipides, Groupement Hospitalier Pitié-Salpêtrière, AP-HP, Paris, France
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  • D. Boutin-Le Thi Huong,

    1. Centre de Référence National pour les Lupus et le Syndrome des Antiphospholipides, Groupement Hospitalier Pitié-Salpêtrière, AP-HP, Paris, France
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  • B. Wechsler,

    1. Centre de Référence National pour les Lupus et le Syndrome des Antiphospholipides, Groupement Hospitalier Pitié-Salpêtrière, AP-HP, Paris, France
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  • B. Hervier,

    1. Centre de Référence National pour les Lupus et le Syndrome des Antiphospholipides, Groupement Hospitalier Pitié-Salpêtrière, AP-HP, Université Pierre et Marie Curie, Université Paris 06, and INSERM UMR-S 945, Paris, France
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  • M. Miyara,

    1. Centre de Référence National pour les Lupus et le Syndrome des Antiphospholipides, Groupement Hospitalier Pitié-Salpêtrière, AP-HP, Université Pierre et Marie Curie, Université Paris 06, and INSERM UMR-S 945, Paris, France
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  • N. Morel,

    1. Centre de Référence National pour les Lupus et le Syndrome des Antiphospholipides, Groupement Hospitalier Pitié-Salpêtrière, AP-HP, Paris, France
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  • N. Le Corre,

    1. INSERM UMR-S 945, Groupement Hospitalier Pitié-Salpêtrière, Paris, France
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  • L. Arnaud,

    1. Centre de Référence National pour les Lupus et le Syndrome des Antiphospholipides, Groupement Hospitalier Pitié-Salpêtrière, AP-HP, Université Pierre et Marie Curie, Université Paris 06, and INSERM UMR-S 945, Paris, France
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  • J. C. Piette,

    1. Centre de Référence National pour les Lupus et le Syndrome des Antiphospholipides, Groupement Hospitalier Pitié-Salpêtrière, AP-HP, Paris, France
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  • L. Musset,

    1. Groupement Hospitalier Pitié-Salpêtrière, AP-HP, Paris, France
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  • B. Autran,

    1. Groupement Hospitalier Pitié-Salpêtrière, AP-HP, Université Pierre et Marie Curie, Université Paris 06, and INSERM UMR-S 945, Paris, France
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  • F. Rozenberg,

    1. Groupement Hospitalier Cochin, AP-HP, and EA 1833, Université Paris Descartes, Sorbonne Paris Cité, Paris, France
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  • Z. Amoura

    1. Centre de Référence National pour les Lupus et le Syndrome des Antiphospholipides, Groupement Hospitalier Pitié-Salpêtrière, AP-HP, Université Pierre et Marie Curie, Université Paris 06, and INSERM UMR-S 945, Paris, France
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Abstract

Objective

To assess the factors influencing the efficacy of 2 injections of a pandemic 2009 influenza A (H1N1) vaccine in patients with systemic lupus erythematosus (SLE).

Methods

We conducted a single-center, observational prospective study of 111 patients who were vaccinated with a monovalent, inactivated, nonadjuvanted, split-virus vaccine during December 2009 and January 2010 and received a second dose of vaccine 3 weeks later. The antibody response was evaluated using the hemagglutination inhibition assay according to the guidelines recommended for the pandemic vaccine, consisting of 3 immunogenicity criteria (i.e., a seroprotection rate of 70%, a seroconversion rate of 40%, and a geometric mean ratio [GMR] of 2.5).

Results

The 3 immunogenicity criteria were met on day 42 (seroprotection rate 80.0% [95% confidence interval (95% CI) 72.5–87.5%], seroconversion rate 71.8% [95% CI 63.4–80.2%], and GMR 10.3 [95% CI 2.9–14.2]), while only 2 criteria were met on day 21 (seroprotection rate 66.7% [95% CI 57.9–75.4%], seroconversion rate 60.4% [95% CI 51.3–69.5%], and GMR 8.5 [95% CI 3.2–12.0]). The vaccine was well tolerated. Disease activity, assessed by the Safety of Estrogens in Lupus Erythematosus National Assessment version of the SLE Disease Activity Index, the British Isles Lupus Assessment Group score, and the Systemic Lupus Activity Questionnaire, did not increase. In the multivariate analysis, vaccination failure was significantly associated with immunosuppressive treatment or a lymphocyte count of ≤1.0 × 109/liter. The second injection significantly increased the immunogenicity in these subgroups, but not high enough to fulfill the seroprotection criterion in patients receiving immunosuppressive treatment.

Conclusion

Our findings indicate that the efficacy of the vaccine was impaired in patients who were receiving immunosuppressive drugs or who had lymphopenia. A second injection increased vaccine immunogenicity without reaching all efficacy criteria for a pandemic vaccine in patients receiving an immunosuppressive agent. These results open possibilities for improving anti-influenza vaccination in SLE.

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