Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.
Seasonal- (SFV) and H1N1-Flu Virus (HFV) Vaccination for Patients with Autoimmune Diseases (AID): The Prospective MAIVAX Trial on 174 Patients.
Kostianovsky2, Alex, Goulet2, Michele, Alves2, Jean Francois, Le Guern2, Veronique, Pagnoux2, Christian, Cohen2, Pascal, Berezne2, Alice
The theoretical risk for AID and immunosuppressed patients exposed to the new H1N1 flu pandemic in June 2009, along with the historical debate on the role of vaccination in the context of AID relapses, led us to evaluate the efficacy and safety of SFV and HFV vaccinations in AID patients treated or not with immunosuppressants (IS).
Patients and Methods:
A monocenter vaccine phase III prospective open study on 174 patients was conducted from September 2009 to June 2010. Subjects received SVF (1 dose, Mutagrip®) and/or non-adjuvant HFV (Panenza®, 2 doses at a 3-wk interval) vaccines. Due to their dates of commercial availability, SFV was administered 3 wk before HFV. The primary judgment criterion was the seroprotection rate: the % patients with positive anti-hemagglutininAb titers (PAT) >=1/40: 3 or 9 wk after SFV and 3 wk after the 2nd HFV shots. Secondary outcome measures were seroconversion rates, vaccine tolerance (no fever >37.8°C and/or local signs during the 3 days postinoculation), and numbers of flu syndromes (fever + cough and/or throat pain) and AID flares throughout the pandemic.
AID included were: 62 systemic vasculitides (polyarteritis nodosa, microscopic polyangiitis, Wegener's granulomatosis, ChurgStrauss syndrome (CSS), Behçet's disease and cryoglobulinemia), 32 progressive systemic sclerosis (PSS), 29 systemic lupus erythematosus (SLE), 23 Sjögren syndrome (SS, with detectable autoAb) and 28 others. After SFV inoculation, 79.13% of the patients were seroprotected (110/139, 106 tested 3 wk and 4 tested 9 wk postvaccination, had PAT), 64 (46%) seroconverted (prevaccination PAT rose 4-fold for 14), 37 (26.6%) had prevaccination PAT; 2 (1.4%) became febrile and 27 (19.4%) developed local signs post-vaccination. After HFV immunization, 65% of the patients (113/174 with PAT) were seroprotected, 94 (54%) seroconverted (prevaccination PAT rose 4-fold for 7), 19 (10.9%) had prevaccination PAT; 6 had become HFV-positive after SFV immunization; 8 (4.6%) developed a fever (6 after the 1st dose and 2 after the 2nd dose) and 39 (22.4%) had local signs.
Concerning adverse events occurring during the study, among 12 patients developing 15 flu syndromes, 2 were temporally related to both vaccines (same patient); 1 patient died of septic shock and 2 AID flares were temporally related to inoculation: polyneuritis in a CSS patient (3 days after the 1st HFV dose), and severe myalgias and arthralgias in a PSS patient (10 days post SFV injection); 4 temporally unrelated AID flares occurred (2 PSS, 1 SLE and 1 SS).
Given the low rates of temporally associated events, tolerance of both vaccines was acceptable. The seroprotection rate was higher after SFV than HFV immunization, for similar seroconversion rates. Potential relationships between these data and ongoing IS are being analyzed. Notably, SFV induced PAT against the H1N1 virus in a minority of patients. Our findings demonstrated the safety and efficacy of SFV and HFV vaccination in AID patients.
To cite this abstract, please use the following information:
Kostianovsky, Alex, Goulet, Michele, Alves, Jean Francois, Le Guern, Veronique, Pagnoux, Christian, Cohen, Pascal, et al; Seasonal- (SFV) and H1N1-Flu Virus (HFV) Vaccination for Patients with Autoimmune Diseases (AID): The Prospective MAIVAX Trial on 174 Patients. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :2043