Retrospective multicenter matched case–control study on the risk factors for narcolepsy with special focus on vaccinations (including pandemic influenza vaccination) and infections in Germany |
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| Institution: | 1. Department Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany;2. Hephata-Klinik, Schlafzentrum, Schwalmstadt-Treysa, Germany;3. Sleep Disorders Center, Department of Psychiatry, University of Regensburg, Regensburg, Germany;1. Dept. of Neurology, Faculty of Medicine Pavol Jozef Safarik University, University Hospital of L. Pasteur, Tr. SNP 1, Kosice, Slovak Republic;2. 1st Department of Neurology, Comenius University, Mickiewiczova 13, Bratislava, Slovak Republic;3. Pediatric Department, Comenius University in Bratislava, Jessenius Faculty of Medicine, Kollárova 2, Martin, Slovak Republic;1. Center for Sleep Sciences and Medicine, Stanford School of Medicine, Palo Alto, CA, USA;2. Stanford University Mass Spectrometry, Palo Alto, CA, USA;1. Department of Neurology, Changzheng Hospital, Second Military Medical University, Shanghai, China;2. Institute of Neuroscience and MOE Key Laboratory of Molecular Neurobiology, Neuroscience Research Center of Changzheng Hospital, Second Military Medical University, Shanghai, China;3. Department of Psychiatry, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, USA;1. Department of Clinical Sciences, Lund University/CRC, Skåne University Hospital SUS, Malmö, Sweden;2. Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden;3. Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden;4. Department of Medicine, Karolinska Institutet, Stockholm, Sweden;5. TIM, LabMed, Karolinska Institutet and CAST, Karolinska Hospital, Stockholm, Sweden;6. Paediatric Clinic, Östersund Hospital, Östersund, Sweden;1. Department of Pediatrics, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden;2. Department of Pediatrics, Halland Hospital, Halmstad, Sweden;3. Memory Clinic, Skåne University Hospital, Lund, Sweden;4. Department of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden |
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| Abstract: | ObjectiveStudies associate pandemic influenza vaccination with narcolepsy. In Germany, a retrospective, multicenter, matched case–control study was performed to identify risk factors for narcolepsy, particularly regarding vaccinations (seasonal and pandemic influenza vaccination) and infections (seasonal and pandemic influenza) and to quantify the detected risks.MethodsPatients with excessive daytime sleepiness who had been referred to a sleep center between April 2009 and December 2012 for multiple sleep latency test (MSLT) were eligible. Case report forms were validated according to the criteria for narcolepsy defined by the Brighton Collaboration (BC). Confirmed cases of narcolepsy (BC level of diagnostic certainty 1?4a) were matched with population-based controls by year of birth, gender, and place of residence. A second control group was established including patients in whom narcolepsy was definitely excluded (test-negative controls).ResultsA total of 103 validated cases of narcolepsy were matched with 264 population-based controls. The second control group included 29 test-negative controls. A significantly increased odd ratio (OR) to develop narcolepsy (crude OR cOR] = 3.9, 95% confidence interval CI] = 1.8–8.5; adjusted OR aOR] = 4.5, 95% CI = 2.0–9.9) was detected in individuals immunized with pandemic influenza A/H1N1/v vaccine prior to symptoms onset as compared to nonvaccinated individuals. Using test-negative controls, in individuals immunized with pandemic influenza A/H1N1/v vaccine prior to symptoms onset, a nonsignificantly increased OR of narcolepsy was detected when compared to nonvaccinated individuals (whole study population, BC levels 1?4a: cOR = 1.9, 95% CI = 0.5–6.9; aOR = 1.8, 95% CI = 0.3–10.1).ConclusionsThe findings of this study support an increased risk for narcolepsy after immunization with pandemic influenza A/H1N1/v vaccine. |
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| Keywords: | Narcolepsy Risk factors Pandemic influenza A/H1N1/v vaccine Germany |
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