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

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Department of Internal Medicine, Hôpital Cochin, Assistance Publique–Hôpitaux de Paris, Université Paris-Descartes, Sorbonne Paris Cité, INSERM U1060, Referral Center for Rare Autoimmune Systemic Diseases, Paris, France. akostianovsky@gmail.com

CER5563 Submission on line
2012 Vol.30, N°1 ,Suppl.70 - PI 0083, PF 0089
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Rheumatology Article



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.
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.
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.
Our findings demonstrated the safety and efficacy of SFV and HFV in AID patients.

PMID: 22640652 [PubMed]

Received: 18/03/2012 - Accepted : 13/04/2012 - In Press: 11/05/2012 - Published: 11/05/2012