Tick-borne encephalitis (TBE) vaccine to medically immunosuppressed patients with rheumatoid arthritis: A prospective,open-label,multi-centre study |
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| Institution: | 1. Karolinska Institutet, Dept. of Medicine/Solna, Unit for Infectious Diseases, SE 17176 Stockholm, Sweden;2. Department of Medical Sciences, Section of Infectious Diseases, Uppsala University, SE 751 85 Uppsala, Sweden;3. Centre for Clinical Research, Sörmland, Uppsala University, SE 631 88 Eskilstuna, Sweden;4. Dept. of Rheumatology, Inst. of Medical Sciences, Uppsala University, SE 751 85 Uppsala, Sweden;5. Public Health Agency of Sweden, Nobels väg 18, SE 17182 Solna, Sweden;6. Dept. of Communicable Diseases Control and Prevention, Box 17533, SE-11891 Stockholm, Sweden;1. Pain and Palliative Care Unit, Aretaieion Hospital, National and Kapodistrian University of Athens, Athens, Greece;2. Institute for Continuing Medical Education of Ioannina, Ioannina, Greece;3. Hematology and Oncology Unit, Second Department of Pediatrics, AHEPA Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece;4. Infectious Disease Unit, Pathophysiology Department, Laikon General Hospital and Medical School, National and Kapodistrian University of Athens, Athens, Greece;1. Vaccination and Travel Medicine Centre, Poliklinika, Hradec Králové, Czech Republic;2. Novartis Vaccines, Emeryville, CA, USA;3. Novartis Vaccines, Basel, Switzerland;1. Am Bachlanger 3, D-82362 Weilheim, Germany;2. Novartis Vaccines and Diagnostics, Inc., Cambridge, MA, USA;3. Novartis Vaccines and Diagnostics GmbH, Marburg, Germany;4. Novartis Vaccines and Diagnostics, Srl., Siena, Italy;1. D.I. Ivanovsky Institute of Virology, 16 Gamaleya Street, 123098, Moscow, Russia;2. Research Institute for Physico-Chemical Medicine of the Federal Medical and Biological Agency of the Russian Federation, 1a Malaya Pirogovskaya Street, 119435 Moscow, Russia;3. Institute of Systematics and Ecology of Animals of the Siberian Branch of the Russian Academy of Sciences, 11 Frunze Street, 630091 Novosibirsk, Russia;4. M.M. Shemyakin and Yu.A. Ovchinnikov Institute of Bioorganic Chemistry of the Russian Academy of Sciences, Moscow, Russia;5. M.P. Chumakov Institute of Poliomyelitis and Viral Encephalites of the Russian Academy of Medical Sciences, 142782 Moscow, Russia;1. Institute of Specific Prophylaxis and Tropical Medicine, Medical University of Vienna, Vienna, Austria;2. Institute of Environmental Health, Medical University of Vienna, Vienna, Austria;1. School of Medical Sciences, Örebro University, SE 701 82 Örebro, Sweden;2. Dept. of Infectious Diseases, Örebro University Hospital, SE 701 85 Örebro, Sweden;3. Swiss Tropical and Public Health Institute, CH 4051 Basel, Switzerland;4. University of Basel, CH 4001 Basel, Switzerland;5. Institute of Virology, Technical University of Munich / Helmholtz Zentrum München, 81675 Munich, Germany;6. Dept. of Laboratory Medicine, Clinical Microbiology, Örebro University Hospital, SE 701 85 Örebro, Sweden;7. Centre for Clinical Research, Sörmland, Uppsala University, SE 631 88 Eskilstuna, Sweden;8. Karolinska Institutet, Dept. of Medicine/Solna, Unit for Infectious Diseases, SE 171 76 Stockholm, Sweden;9. Dept. of Communicable Diseases Control and Prevention, Sörmland, SE 631 88 Eskilstuna, Sweden |
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| Abstract: | BackgroundTick-borne Encephalitis (TBE) is endemic in south-eastern Sweden as well as in the Baltic regions, Central Europe and Russia. Ageing and immunosuppressed individuals are more prone to severe disease and neurological complications. We assessed the immunogenicity of TBE-vaccine in rheumatoid arthritis (RA) patients treated with tumor necrosis factor-inhibitors (TNFi) and/or methotrexate (MTX).MethodsTBE vaccine, FSME-Immune® or Encepur®, was administered to non-immune RA patients as well as age and gender matched healthy controls. Individuals <60 years of age were given three doses at month 0, 1, 12. Individuals ≥60 years old were given an additional priming dose at month 3, i.e. a total of four doses. Tick-borne encephalitis neutralizing antibodies were assessed by a rapid fluorescent focus inhibition test.ResultsThe study population consisted of 66 patients and 56 age and gender matched healthy controls. Median age was 58.5 years. The patients were either treated with TNFi (n = 16), TNFi + MTX (n = 36) or MTX (n = 14). After the last TBE-vaccine dose, given one year after the first, 39% of the patients compared to 79% of the healthy controls had seroprotective levels (p = <0.05).ConclusionsStandard TBE-vaccine schedule does not confer enough immunogenicity in this group of immunosuppressed patients, who should be carefully informed about a higher risk for vaccination failure and risk of infection when exposed in high-endemic areas. |
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| Keywords: | Tick-borne encephalitis Vaccination Immunosuppression Rheumatoid arthritis TNF-inhibitors Methotrexate |
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