Immunogenicity and safety of seasonal and 2009 pandemic A/H1N1 influenza vaccines for patients with autoimmune diseases:  a prospective, monocentre trial on 199 patients.
OBJECTIVE
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.
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
Alex
A
Kostianovsky
Pierre
P
Charles
Jean-François
JF
Alves
Michèle
M
Goulet
Christian
C
Pagnoux
Véronique
V
Le Guern
Luc
L
Mouthon
Anne
A
Krivine
Peter
P
Villiger
Odile
O
Launay
Loïc
L
Guillevin
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000914:Antibodies, Viral / Q000097:blood; D001327:Autoimmune Diseases / Q000150:complications* / Q000188:drug therapy / Q000276:immunology; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D007251:Influenza, Human / Q000150:complications / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D058873:Pandemics / Q000517:prevention & control*; D010297:Paris; D061214:Patient Safety; D011446:Prospective Studies; D012008:Recurrence; D018570:Risk Assessment; D012307:Risk Factors; D012621:Seasons; D013997:Time Factors; D055815:Young Adult
D000914:Antibodies, Viral; D007166:Immunosuppressive Agents; D007252:Influenza Vaccines; C011937:mutagrip; C560398:panenza vaccine