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Abstract
Objectives: In this study we analyzed the clinical and demographic manifestations among patients diagnosed with immune/autoimmune-mediated diseases post-hepatitis B vaccination. We aimed to find common denominators for all patients, regardless of different diagnosed diseases, as well as the correlation to the criteria of Autoimmune (Auto-inflammatory) Syndrome induced by Adjuvants (ASIA).
Patients and methods: We have retrospectively analyzed the medical records of 114 patients, from different centers in the USA, diagnosed with immune-mediated diseases following immunization with hepatitis-B vaccine (HBVv). All patients in this cohort sought legal consultation. Of these, 93/114 patients diagnosed with disease before applying for legal consultation were included in the study. All medical records were evaluated for demographics, medical history, number of vaccine doses, peri-immunization adverse events and clinical manifestations of diseases. In addition, available blood tests, imaging results, treatments and outcomes were recorded. Signs and symptoms of the different immune-mediated diseases were grouped according to the organ or system involved. ASIA criteria were applied to all patients.
Results: The mean age of 93 patients was 26.5 ± 15 years; 69.2% were female and 21% were considered autoimmune susceptible. The mean latency period from the last dose of HBVv and onset of symptoms was 43.2 days. Of note, 47% of patients continued with the immunization program despite experiencing adverse events. Manifestations that were commonly reported included neuro-psychiatric (70%), fatigue (42%) mucocutaneous (30%), musculoskeletal (59%) and gastrointestinal (50%) complaints. Elevated titers of autoantibodies were documented in 80% of sera tested. In this cohort 80/93 patients (86%), comprising 57/59 (96%) adults and 23/34 (68%) children, fulfilled the required criteria for ASIA.
Conclusions: Common clinical characteristics were observed among 93 patients diagnosed with immune-mediated conditions post-HBVv, suggesting a common denominator in these diseases. In addition, risk factors such as history of autoimmune diseases and the appearance of adverse event(s) during immunization may serve to predict the risk of post-immunization diseases. The ASIA criteria were found to be very useful among adults with post-vaccination events. The application of the ASIA criteria to pediatric populations requires further study.
References
| 1. | Case, CL, King-Thom, C. Montagu and Jenner: The campaign against smallpox. SIM News 1997; 47: 58–60. Google Scholar |
| 2. | Balfe, P . Edward Jenner and vaccination in context: Lady Mary got there first. Microbiol Today 1999; 26: 172–172. Google Scholar |
| 3. | Elgouhari, HM, Abu-Rajab Tamimi, TI, Carey, WD. Hepatitis B virus infection: understanding its epidemiology, course and diagnosis. Cleve Clin J Med 2008; 75: 881–889. Google Scholar | Crossref | Medline | ISI |
| 4. | Dienstag, JL . Hepatitis B virus infection. N Engl J Med 2009; 360: 305–305. Google Scholar | Medline | ISI |
| 5. | Tsai, WL, Chung, RT. Viral hepatocarcinogenesis. Oncogene 2010; 29: 2309–2324. Google Scholar | Crossref | Medline | ISI |
| 6. | Chang, MH . Hepatitis B virus and cancer prevention. Recent Results Cancer Res 2011; 188: 75–84. Google Scholar | Crossref | Medline |
| 7. | Szmuness, W, Stevens, CE, Harley, EJ. Hepatitis B vaccine: demonstration of efficacy in a controlled clinical trial in a high-risk population in the United States. N Engl J Med 1980; 303: 833–841. Google Scholar | Crossref | Medline | ISI |
| 8. | Stevens, CE, Taylor, PE, Tong, MJ. Yeast-recombinant hepatitis B vaccine: efficacy with hepatitis B immune globulin in prevention of perinatal hepatitis B virus transmission. JAMA 1987; 257: 2612–2616. Google Scholar | Crossref | Medline | ISI |
| 9. | Poovorawan, Y, Sanpavat, S, Pongpuniert, W. Protective efficacy of a recombinant DNA hepatitis B vaccine in neonates of HBe antigen-positive mothers. JAMA 1989; 26: 3278–3281. Google Scholar | Crossref |
| 10. | Marcellin, P . Hepatitis B and hepatitis C in 2009. Liver Int 2009; 29(Suppl 1): 1–8. Google Scholar | Crossref | Medline | ISI |
| 11. | Chang, MH . Cancer prevention by vaccination against hepatitis B. Recent Results Cancer Res 2009; 181: 85–94. Google Scholar | Crossref | Medline |
| 12. | CDC. Surveillance for acute viral hepatitis, United States, 2006. Surveillance Summaries; 2008/Vol. 57/No. SS-2. MMWR, www.cdc.gov/mmwr. Google Scholar |
| 13. | Agmon-Levin, N, Paz, Z, Israeli, E, Shoenfeld, Y. Vaccines and autoimmunty. Nat Rev Rheumatol 2009; 5: 648–652. Google Scholar | Crossref | Medline | ISI |
| 14. | Altman, A, Szyper-Kravitz, M, Shoenfeld, Y. HBV vaccine and dermatomyositis. Rheumatol Int 2008; 28: 609–612. Google Scholar | Crossref | Medline | ISI |
| 15. | Choffray, A, Pinquier, L, Bachelez, H. Exacerbation of lupus panniculitis following anti hepatitis B vaccination. Dermatology 2007; 215: 152–154. Google Scholar | Crossref | Medline | ISI |
| 16. | Stübgen, JP . Neuromuscular disorders associated with Hepatitis B vaccination. J Neurol Sci 2010; 292: 1–4. Google Scholar | Crossref | Medline | ISI |
| 17. | Mikaeloff, Y, Caridade, G, Suissa, S, Tardieu, M. Hepatitis B vaccine and the risk of CNS inflammatory demyelination in childhood. Neurology 2009; 72: 873–880. Google Scholar | Crossref | Medline | ISI |
| 18. | Evans, D, Cauchemez, S, Hayden, FG. “Prepandemic” immunization for novel influenza viruses, “swine flu” vaccine, Guillain-Barré syndrome, and the detection of rare severe adverse events. J Infect Dis 2009; 200: 321–328. Google Scholar | Crossref | Medline | ISI |
| 19. | Lasky, T, Terracciano, GJ, Magder, L. The Guillain-Barre syndrome and the 1992–1993 and 1993–1994 influenza vaccines. N Engl J Med 1998; 339: 1797–1802. Google Scholar | Crossref | Medline | ISI |
| 20. | Shoenfeld, Y, Agmon-Levin, N. 'ASIA' - autoimmune/inflammatory syndrome induced by adjuvants. J Autoimmun 2011; 36: 4–8. Google Scholar | Crossref | Medline | ISI |
| 21. | Satoh, M, Reeves, WH. Induction of lupus-associated autoantibodies in BALB/c mice by intraperitoneal injection of pristane. J Exp Med 1994; 180: 2341–2346. Google Scholar | Crossref | Medline | ISI |
| 22. | Reeves, WH, Lee, PY, Weinstein, JS, Satoh, M, Lu, L. Induction of autoimmunity by pristane and other naturally occurring hydrocarbons. Trends Immunol 2009; 30: 455–464. Google Scholar | Crossref | Medline | ISI |
| 23. | Santoro, D, Stella, M, Montalto, G, Castellin, S. Lupus nephritis after Hepatitis B vaccination: an uncommon complication. Clin Nephrol 2007; 67: 61–63. Google Scholar | Crossref | Medline | ISI |
| 24. | Fairweather DL, Rose NR. Women and autoimmune diseases. Emerging Infectious Diseases. http://findarticles.com/p/articles/mi_m0GVK/is_11_10/ai_n7577426/(2004). Google Scholar |
| 25. | Bhat, A, Naguwa, S, Cheema, G, Gershwin, ME. The epidemiology of transverse myelitis. Autoimmun Rev 2010; 9: A395–A399. Google Scholar | Crossref | Medline | ISI |
| 26. | Borchers, AT, Naguwa, SM, Shoenfeld, Y, Gershwin, ME. The geoepidemiology of systemic lupus erythematosus. Autoimmun Rev 2010; 9: A277–A287. Google Scholar | Crossref | Medline | ISI |
| 27. | Borchers, AT, Uibo, R, Gershwin, ME. The geoepidemiology of type 1 diabetes. Autoimmun Rev 2010; 9: A355–A365. Google Scholar | Crossref | Medline | ISI |
| 28. | Brooks, WH, Le Dantec, C, Pers, JO, Youinou, P, Renaudineau, Y. Epigenetics and autoimmunity. J Autoimmun 2010; 34: J207–J219. Google Scholar | Crossref | Medline | ISI |
| 29. | Lambert, JF, Nydegger, UE. Geoepidemiology of autoimmune hemolytic anemia. Autoimmun Rev 2010; 9: A350–A354. Google Scholar | Crossref | Medline | ISI |
| 30. | Logan, I, Bowlus, CL. The geoepidemiology of autoimmune intestinal diseases. Autoimmun Rev 2010; 9: A372–A378. Google Scholar | Crossref | Medline | ISI |
| 31. | Meyer, A, Levy, Y. Geoepidemiology of myasthenia gravis. Autoimmun Rev 2010; 9: A383–A386. Google Scholar | Crossref | Medline | ISI |
| 32. | Milo, R, Kahana, E. Multiple sclerosis: geoepidemiology, genetics and the environment. Autoimmun Rev 2010; 9: A387–A394. Google Scholar | Crossref | Medline | ISI |
| 33. | Prieto, S, Grau, JM. The geoepidemiology of autoimmune muscle disease. Autoimmun Rev 2010; 9: A330–A334. Google Scholar | Crossref | Medline | ISI |
| 34. | Selmi, C . The worldwide gradient of autoimmune conditions. Autoimmun Rev 2010; 9: A247–A250. Google Scholar | Crossref | Medline | ISI |
| 35. | Shapira, Y, Agmon-Levin, N, Shoenfeld, Y. Defining and analyzing geoepidemiology and human autoimmunity. J Autoimmun 2010; 34: J168–J177. Google Scholar | Crossref | Medline | ISI |
| 36. | Davidson, A, Diamond, B. Autoimmune diseases. N Engl J Med 2011; 345: 340–350. Google Scholar | Crossref | ISI |
| 37. | Shoenfeld, Y, Zandman-Goddard, G, Stojanovich, L. The mosaic of autoimmunity: hormonal and environmental factors involved in autoimmune diseases–2008. Isr Med Assoc J 2008; 10: 8–12. Google Scholar | Medline | ISI |
| 38. | Kivity, S, Agmon-Levin, N, Blank, M, Shoenfeld, Y. Infections and autoimmunity. Trends Immunol 2009; 30: 409–414. Google Scholar | Crossref | Medline | ISI |
| 39. | Israeli, E, Agmon-Levin, N, Blank, M, Shoenfeld, Y. Adjuvants and autoimmunity. Lupus 2009; 18: 1217–1225. Google Scholar | SAGE Journals | ISI |
| 40. | Arbuckle, MR, McClain, MT, Rubertone, MV. Development of autoantibodies before the clinical onset of systemic lupus erythematosus. N Engl J Med 2003; 349: 1526–1533. Google Scholar | Crossref | Medline | ISI |
| 41. | Edwards, CJ, Syddall, H, Jameson, K. The presence of anticardiolipin antibodies in adults may be influenced by infections in infancy. QJM 2008; 101: 41–47. Google Scholar | Crossref | Medline |
| 42. | Ray, P, Black, S, Shinefield, H. Risk of rheumatoid arthritis following vaccination with tetanus, influenza and hepatitis B vaccination among persons 15–59 years of age. Vaccine 2011; 29: 6592–6597. Google Scholar | Crossref | Medline | ISI |
| 43. | Iñiguez, C, Mauri, JA, Larrodé, P. Acute transverse myelitis secondary to hepatitis B vaccination. Rev Neurol 2000; 5; 31: 430–432. Google Scholar | Medline | ISI |
| 44. | Renard, JL, Guillamo, JS, Ramirez, JM. Acute transverse cervical myelitis following hepatitis B vaccination. Evolution of anti-HBs antibodies. Presse Med 1999; 28: 1290–1292. Google Scholar | Medline | ISI |
| 45. | Fonseca, LF, Noce, TR, Teixeira, ML. Early-onset acute transverse myelitis following hepatitis B vaccination and respiratory infection: case report. Arq Neuropsiquiatr 2003; 61: 265–268. Google Scholar | Crossref | Medline | ISI |
| 46. | Piaggio, E, Ben Younes, A, Desbois, S. Hepatitis B vaccination and central nervous system demyelination: an immunological approach. J Autoimmun 2005; 4: 33–37. Google Scholar | Crossref | ISI |
| 47. | Tomljenovic L, Shaw CA. Mechanisms of aluminum adjuvant toxicity in pediatric populations. Lupus 2012; 21: 223--230. Google Scholar |
| 48. | Israeli E, Agmon-Levin N, Blank M, Shoenfeld Y. Macrophagic myofasciitis, a vaccine (alum) autoimmune-related disease. Clin Rev Allergy Immunol 2011; 41: 163–168. Google Scholar |
