Immunogenicity and safety of seasonal and 2009 pandemic A/H1N1 influenza vaccines for patients with autoimmune diseases: a prospective, monocentre trial on 199 patients

Clinical and Experimental Rheumatology

Alex Kostianovsky¹  Luc Mouthon¹  Jean-Francois Alves¹  Loïc Guillevin¹  Christian Pagnoux¹  Pierre Charles¹  Michèle Goulet¹  Veronique Le Guern¹  Odile Launay¹  Peter Villiger¹  Anne Krivine¹ 

关键词: Autoimmune diseases;    vaccination;    flu;    Vasculitis;    flu;    vaccination;    autoimmune diseases;   

DOI  :  

学科分类：医学（综合）

来源: Pacini Editore SpA

【 摘 要 】

OBJECTIVES: The 2009 pandemic A/H1N1 influenza outbreak represented a theoretical risk for patients with autoimmune diseases (AID), especially those immunosuppressed. This study was undertaken to evaluate immunogenicity and tolerance of seasonal (SFV) and A/H1N1 flu vaccines (HFV) in AID patients. METHODS: This prospective, open, monocentre, vaccine phase-III study on 199 patients with AID (systemic necrotising vasculitides, progressive systemic sclerosis, systemic lupus erythematosus, Sjögren`s syndrome and others), treated or not with immunosuppressants, was conducted from September 2009 to June 2010, to evaluate SFV and HFV efficacy and safety. Subjects received SFV (1 dose, Mutagrip®) and/or non-adjuvant HFV (Panenza®, 2 doses at a 3-week interval). The primary judgment criterion was the seroprotection rate. Secondary outcome measures were seroconversion rates, vaccine tolerance, and numbers of flu syndromes, and AID flares and relapses throughout the 6 month observation period. RESULTS: After SFV inoculation, 1% of the patients became febrile, 18% developed local reactions, 80% were seroprotected and 38% seroconverted. After HFV immunisation, 4% of the patients developed a fever, 23% had local reactions, 65% were seroprotected and 83% seroconverted. Twelve patients developed 15 flu syndromes (3 patients developed 2 syndromes each); 2 of these episodes were temporally consistent with vaccination; 1 patient died of septic shock unrelated to vaccination. Nineteen mild AID flares occurred during follow-up, only 6 being temporally consistent with HFV and SFV. CONCLUSIONS: Our findings demonstrated the safety and efficacy of SFV and HFV in AID patients.

【 授权许可】

Unknown