Journal Article

Immunogenicity and safety of the 2009 non-adjuvanted influenza A/H1N1 vaccine in a large cohort of autoimmune rheumatic diseases

Fuller, Ricardo, Caleiro, Maria T, Timenetsky, Maria do Carmo S, Goncalves, Celio R, Moraes, Julio C B, França, Ivan L A, Levy-Neto, Mauricio, Guedes, Lissiane K N, Shinjo, Samuel K, Pereira, Rosa M R, Carvalho, Jozelio F, Ribeiro, Ana C M, Borba, Eduardo F, Silva, Clovis A, Saad, Carla G S, Aikawa, Nadia E, Calich, Ana Luisa, Sampaio-Barros, Percival D, Bonfa, Eloisa, Viana, Vilma S T, Pasoto, Sandra G, Precioso, Alexander R

2011

Overview

Background Despite the WHO recommendation that the 2010–2011 trivalent seasonal flu vaccine must contain A/California/7/2009/H1N1-like virus there is no consistent data regarding its immunogenicity and safety in a large autoimmune rheumatic disease (ARD) population. Methods 1668 ARD patients (systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), ankylosing spondylitis (AS), systemic sclerosis, psoriatic arthritis (PsA), Behçet's disease (BD), mixed connective tissue disease, primary antiphospholipid syndrome (PAPS), dermatomyositis (DM), primary Sjögren's syndrome, Takayasu's arteritis, polymyositis and Granulomatosis with polyangiitis (Wegener's) (GPA)) and 234 healthy controls were vaccinated with a non-adjuvanted influenza A/California/7/2009(H1N1) virus-like strain flu. Subjects were evaluated before vaccination and 21 days post-vaccination. The percentage of seroprotection, seroconversion and the factor increase in geometric mean titre (GMT) were calculated. Results After immunisation, seroprotection rates (68.5% vs 82.9% p<0.0001), seroconversion rates (63.4% vs 76.9%, p<0.001) and the factor increase in GMT (8.9 vs 13.2 p<0.0001) were significantly lower in ARD than controls. Analysis of specific diseases revealed that seroprotection significantly reduced in SLE (p<0.0001), RA (p<0.0001), PsA (p=0.0006), AS (p=0.04), BD (p=0.04) and DM (p=0.04) patients than controls. The seroconversion rates in SLE (p<0.0001), RA (p<0.0001) and PsA (p=0.0006) patients and the increase in GMTs in SLE (p<0.0001), RA (p<0.0001) and PsA (p<0.0001) patients were also reduced compared with controls. Moderate and severe side effects were not reported. Conclusions The novel recognition of a diverse vaccine immunogenicity profile in distinct ARDs supports the notion that a booster dose may be recommended for diseases with suboptimal immune responses. This large study also settles the issue of vaccine safety. (ClinicalTrials.gov #NCT01151644)

• Publisher: BMJ Publishing Group Ltd and European League Against Rheumatism,BMJ Publishing Group,Elsevier Limited
• Subject: Adjuvants, Immunologic / Adult / Antibodies, Viral - biosynthesis / Antigens / Autoimmune Diseases - immunology / Biological and medical sciences / Disease / Diseases of the osteoarticular system / Epidemiologic Methods / Female / Health care / Hospitals / Human viral diseases / Humans / Immune Tolerance / Immunocompromised Host / Infections / Infectious diseases / Influenza A Virus, H1N1 Subtype - immunology / Influenza Vaccines - adverse effects / Influenza Vaccines - immunology / Influenza, Human - prevention & control / Laboratories / Lupus / Male / Medical sciences / Middle Aged / Miscellaneous. Osteoarticular involvement in other diseases / Pandemics / Primaries & caucuses / Public health / Rheumatic diseases / Rheumatic Diseases - immunology / Rheumatology / Studies / Swine flu / TNF inhibitors / Vaccination - adverse effects / Vaccination - methods / Vaccines / Viral diseases / Viral diseases of the respiratory system and ent viral diseases / Viruses / Young Adult