Aluminium in allergen-specific subcutaneous immunotherapy - A German perspective

Vaccine

Volumn 32, Issue 33, 2014, Pages 4140-4148

  Kramer, Matthias F ^a   Heath, Matthew D ^b  

^a Bencard Allergie GmbH   (Germany)

^b Allergy Therapeutics ^*  (United Kingdom)

Author keywords

Aluminium; Immunotherapy; Safety; Toxicity

Indexed keywords

ALLERGEN; ALUMINUM; ALUMINUM DERIVATIVE; ALUMINUM SALT; IMMUNOLOGICAL ADJUVANT;

ACUTE TOXICITY; ANTIGEN SPECIFICITY; ARTICLE; ATOMIC ABSORPTION SPECTROMETRY; BODY BURDEN; BREAST CANCER; BREAST TUMOR; CHRONIC TOXICITY; COUPLED PLASMA OPTICAL EMISSION SPECTROMETRY; DEGENERATIVE DISEASE; DIALYSIS ENCEPHALOPATHY; DRUG ACCUMULATION; DRUG EFFICACY; DRUG EXPOSURE; DRUG SAFETY; DRUG SCREENING; FASCIITIS; GRAPHITE FURNACE ATOMIC ABSORPTION SPECTROMETRY; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; IMMUNOPROPHYLAXIS; IMMUNOREACTIVITY; IMMUNOTOXICITY; MEDICAL TECHNOLOGY; NEUROTOXICITY; NONHUMAN; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; SHORT COURSE THERAPY; SILICOSIS; SPECTROMETRY; SUBCUTANEOUS IMMUNOTHERAPY; TH2 CELL; TREATMENT DURATION; VACCINATION; VACCINATION REACTION; VACCINE PRODUCTION; VASCULAR AMYLOIDOSIS; WATER CONTAMINATION; DESENSITIZATION; MAXIMUM ALLOWABLE CONCENTRATION; RISK ASSESSMENT; SUBCUTANEOUS DRUG ADMINISTRATION; TOXICITY;

ADJUVANTS, IMMUNOLOGIC; ALUMINUM; DESENSITIZATION, IMMUNOLOGIC; HUMANS; INJECTIONS, SUBCUTANEOUS; RISK ASSESSMENT; THRESHOLD LIMIT VALUES;

EID: 84903455050     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2014.05.063     Document Type: Article

References (77)

1. Priest N.D., Talbot R.J., Newton D., Day J.P., King S.J., Fifield L.K. Uptake by man of aluminum in a public water supply. Hum Exp Toxicol 1988, 17:296-301.
2. Exley C. Human exposure to aluminium. Environ Sci Process Impacts 2013, 15(10):1807-1816.
3. Sigel H., Sigel A. Aluminum and its role in biology. Metal ions in biological systems 1988, vol. 24. Marcel Dekker, New York.
4. Krewski D., Yokel R.A., Nieboer E., Borchelt D., Cohen J., Harry J., et al. Human health risk assessment for aluminium, aluminium oxide, and aluminium hydroxide. J Toxicol Environ Health B Crit Rev 2007.
5. Smith R.W. Kinetic aspects of aqueous aluminum chemistry: environmental implications. Coord Chem Rev 1996, 149:81-93.
6. Berthon G. Aluminium speciation in relation to aluminium bioavailability, metabolism and toxicity. Coord Chem Rev 2002, 228:319-341.
7. Greger J.L., Baier M.J. Excretion and retention of low or moderate levels of aluminium by human subjects. Food Chem Toxicol 1983, 21:473-477.
8. Rondeau V., Jacqmin-Gadda H., Commenges D., Helmer C., Dartigues J.-F. Aluminum and silica in drinking water and the risk of Alzheimer's disease or cognitive decline: findings from 15-year follow-up of the PAQUID cohort. Am J Epidemiol 2009, 169:489-496.
9. Froment D.P., Molitoris B.A., Buddington B., Miller N., Alfrey A.C. Site and mechanism of enhanced gastrointestinal absorption of aluminum by citrate. Kidney Int 1989, 36:978-984.
10. Harris W.R., Berthon G., Day J.P., Exley C., Flaten T.P., Forbes W.F., et al. Speciation of aluminum in biological systems. J Toxicol Environ Health 1996, 48:543-568.
11. Rondeau V., Commenges D., Jacqmin-Gadda H., Dartigues J.F. Relation between aluminum concentrations in drinking water and Alzheimer's disease: an 8-year follow-up study. Am J Epidemiol 2000, 152:59-66.
12. Minshalla C., Nadala J., Exley C. Aluminium in human sweat. J Trace Elem Med Biol 2014, 28:87-88.
13. Exley C. Does antiperspirant use increase the risk of aluminium-related disease, including Alzheimer's disease?. Mol Med Today 1998, 3:107-109.
14. Darbre P.D., Mannello F., Exley C. Aluminium and breast cancer: sources of exposure, tissue measurements and mechanisms of toxicological actions on breast biology. J Inorg Biochem 2013, 128:257-261.
15. Federal Institute for Risk Assessment Aluminium-containing antiperspirants contribute to the absorption of aluminum. Opinion Number 007/2014 of the Bundesinstitut für Risikobewertung (BfR) 2014.
16. De Sole P., Rossi C., Chiarpotto M., Ciasca G., Bocca B., Alimonti A., et al. Possible relationship between Al/ferritin complex and Alzheimer's disease. Clin Biochem 2013, 46:89-93.
17. 26Al exposure. Toxicol Sci 2001, 64:77-82.
18. European Food Safety Authority Safety of aluminum from dietary intake. Scientific opinion of the panel on food additives, flavourings, processing aids and materials in contact with food. EFSA J 2008, 754:1-34.
19. World Health Organisation Safety evaluation of certain food additives and contaminants. WHO Food additives 67 2012.
20. Chuchu N., Patel B., Sebastian B., Exley C. The aluminium content of infant formulas remains too high. BMC Pediatr 2013, 13:162.
21. Shelle-Ann M.Burrell., Exley Christopher There is (still) too much aluminium in infant formulas. BMC Pediatr 2010, 10:63.
22. European Medicines Agency CHMP Safety Working Party's response to the PDCO regarding aluminium hydroxide contained in allergen products. EMA/CHMP/381064/2010 2010.
23. Alfrey A.C., Le Gendre G.R., Kaehny W.D. The dialysis encephalopathy syndrome-possible aluminium intoxication. N Engl J Med 1976, 294:184-188.
24. Mcdermott J.R., Smith A.I., Ward M.K., Parkinson I.S., Kerr D.N.S. Brain-aluminium concentration in dialysis encephalopathy. Lancet 1978, 311:901-904.
25. Berend K., van der Voet G., Boer W.H. Acute aluminum encephalopathy in a dialysis center caused by a cement mortar water distribution pipe. Kidney Int 2001, 59:746-753.
26. Exley C., Korchazhkina O., Job D., Strekopytov S., Polwart A., Crome P. Non-invasive therapy to reduce the body burden of aluminium in Alzheimer's disease. J Alzheimers Dis 2006, 10(1):17-24.
27. Exley C., House E.R. Aluminium in the human brain. Metal IonsNeurol Systems 2011, 142:95-101.
28. Davenward S., Bentham P., Wright J., Crome P., Job D., Polwart A., et al. Silicon-rich mineral water as a non-invasive test of the 'aluminum hypothesis' in Alzheimer's disease. J Alzheimers Dis 2013, 33(2):423-430.
29. Crombie D.W., Blaisdell J.L., MacPherson G. The treatment of silicosis by aluminium powder. Can Med Assoc J 1944, 50:318-328.
30. Rifat S.L., Eastwood M.R., McLachlan D.R., Corey P.N. Effect of exposure of miners to aluminum powder. Lancet 1990, 336:1162-1165.
31. Altmann P., Cunningham J., Dhanesha U., Ballard M., Thompson J., Marsh F. Disturbance of cerebral function in people exposed to drinking water contaminated with aluminum sulphate: retrospective study of the Camelford water incident. Br Med J 1999, 319:807-811.
32. Exley C., Esiri M.M. Severe cerebral congophilic angiopathy coincident with increased brain aluminium in a resident of Camelford, Cornwall, UK. J Neurol Neurosurg Psychiatry 2006, 77:877-879.
33. Ohyagi Y., Miyoshi K. Aluminum and Alzheimer's disease: an update. J Alzheimers Dis Parkinsonism 2013, 3:118.
34. Bondy S.C. Prolonged exposure to low levels of aluminum leads to changes associated with brain aging and neurodegeneration. Toxicology 2014, 315:1-7.
35. Pleschka S. Aluminium im Alltag. Allergie konkret 2013, 4:8-9.
36. Authier F.J., Cherin P., Creange A., Bonnotte B., Ferrer X., Abdelmoumni D., et al. Central nervous system disease in patients with macrophagic myofasciitis. Brain 2001, 124:974-983.
37. Gherardi R.K., Coquet M., Cherin P., Belec L., Moretto P., Dreyfus P.A., et al. Macrophagic myofasciitis lesions assess long-term persistence of vaccine-derived aluminium hydroxide in muscle. Brain 2001, 124:1821-1831.
38. Exley C., Swarbrick L., Gherardi R.K., Authier F.J. A role for the body burden of aluminium in vaccine-associated macrophagic myofasciitis and chronic fatigue syndrome. Med Hypotheses 2009, 72(2):135-139.
39. Khan Z., Combadière C., Authier F.-J., Itier V., Lux F., Exley C., et al. Slow CCL2-dependent translocation of biopersistent particles from muscle to brain. BMC Med 2013, 11:99.
40. Tomljenovic L., Shaw C.A. Do aluminum vaccine adjuvants contribute to the rising prevalence of autism?. J Inorg Biochem 2011, 105:1489-1499.
41. Tomljenovic L., Shaw C.A. Aluminum vaccine adjuvants: are they safe?. Curr Med Chem 2011, 18:2630-2637.
42. Hem S.L., Hogenesch H. Relationship between physical and chemical properties of aluminium-containing adjuvants and immunopotentiation. Expert Rev Vaccines 2007, 6(5):685-698.
43. Glenny A.T., Pope C.G., Waddington H., Wallace U. Immunological notes. J Pathol Bact 1926, 29:31.
44. Awate S., Babiuk L.A., Mutwiri G. Mechanism of action of adjuvants. Front Immunol 2013, 4:114.
45. Clements C.J., Griffiths E. The global impact of vaccines containing aluminium adjuvants. Vaccine 2002, 31:20.
46. Exley C., Siesjö P., Eriksson H. The immunobiology of aluminium adjuvants: how do they really work?. Trends Immunol 2010, 31:103-109.
47. Grun J.L., Maurer P.H. Different T helper cell subsets elicited in mice utilizing two different adjuvant vehicles: the role of endogenous interleukin 1 in proliferative responses. Cell Immunol 1989, 121(1):134-145.
48. Jordan M.B., Mills D.M., Kappler J., Marrack P., Cambier J.C. Promotion of B cell immune responses via an alum-induced myeloid cell population. Science 2004, 304(5678):1808-1810.
49. Wang H.B., Weller P.F. Pivotal advance: eosinophils mediate early alum adjuvant-elicited B cell priming and IgM production. J Leukoc Biol 2008, 83(4):817-821.
50. Serre K., Mohr E., Toellner K.M., Cunningham A.F., Granjeaud S., Bird R., et al. Molecular differences between the divergent responses of ovalbumin-specific CD4 T cells to alum-precipitated ovalbumin compared to ovalbumin expressed by Salmonella. Mol Immunol 2008, 45(13):3558-3566.
51. Keith L.S., Jones D.E., Chou C.-H.S.J. Aluminum toxicokinetics regarding infant diet and vaccinations. Vaccine 2002, 20:S13-S17.
52. Baylor N.W., Egan W., Richman P. Aluminium salts in vaccines-US perspective. Vaccine 2002, 31(20):18-23.
53. Exley C. Aluminium adjuvants should not be used as placebos in clinical trials. Vaccine 2011, 29:9289.
54. Franzoesische Nationalversammlung - Study Group on Immunization Summary of recommendations of the study group on immunization 2012, http://pdf.20mn.fr/2012/autres/ge-vaccination.pdf [accessed 03.01.14].
55. Kleine-Tebbe J., Bufe A., Ebner C., Eigenmann P., Friedrichs F., Fuchs T., et al. Specific immunotherapy (hyposensitization) for IgE-mediated allergic diseases. Guideline of the German Society for Allergology and Clinical Immunology (DGAKI), the Association of German Allergists (ÄDA), the Society for Pediatric Allergology and Environmental Medicine (GPA), the Austrian Society for Allergology and Immunology (ÖGAI) and the Swiss Society for Allergology and Immunology (SSAI). Allergo J 2009, 18:508-537.
56. Przybilla B., Ruëff F., Walker A., Räwer H.-C., Aberer W., Bauer C.P., et al. Diagnosis and treatment of bee and wasp venom allergy guideline of the German Society for Allergology and Clinical Immunology (DGAKI), the Association of German Allergists (ÄDA), the Society for Pediatric Allergology and Environmental Medicine (GPA), the German Dermatological Society (DDG) and the German society for Pediatric and Adolescent Medicine (DGKJ) in cooperation with the Austrian Society for Allergology and Immunology (ÖGAI) and the Swiss society for Allergology and Immunology (SSAI). Allergo J 2011, 20:318-339.
57. Leith E., Bowen T., Butchey J., Fischer D., Kim H., Moote B., et al. Consensus guidelines on practical issues of immunotherapy-Canadian Society of Allergy and Clinical Immunology (CSACI). Allergy Asthma Clin Immunol 2006, 2:47-61.
58. Senti G., Prinz Vavricka B.M., Erdmann I., Diaz M.I., Markus R., McCormack S.J., et al. Intralymphatic allergen administration renders specific immunotherapy faster and safer: a randomized controlled trial. Proc Natl Acad Sci USA 2008, 105:17908-17912.
59. Exley C. Aluminium adjuvants and adverse events in subcutaneous allergy immunotherapy. Allergy Asthma Clin Immunol 2014, 10:4.
60. Ph.Eur.8.ed Vaccines for human use 2013, pp.3971. (note: guidelines on European Alum limits).
61. Jung K. Safety and tolerability of immunotherapy using various updosing schedules of a new SCIT product with an optimised allergen/aluminium hydroxide ratio. Allergy 2011, 66:41-43.
62. Blumberga G., Groes L., Dahl R. SQ-standardized house dust mite immunotherapy as an immunomodulatory treatment in patients with asthma. Allergy 2011, 66(2):178-185.
63. 26Al. Vaccine 1997, 15(12-13):1314-1318.
64. Casale M.D., Stokes J.R. Immunotherapy: what lies beyond. J Allergy Clin Immunol 2014, 133(3):612-619.
65. CHMP Safety Working Party response to the PDCO regarding Aluminium Hydroxide contained in Allergen Products. (EMA/CHMP/381064/2010).
66. [accessed 01.03.14]. http://www.pei.de/DE/arzneimittelsicherheit-vigilanz/archiv-sicherheitsinformationen/2014/ablage2014/2014-01-21-sicherheitsbewertung-von-aluminium-in-therapieallergenen.html.
67. AVANZ PI and SmPC (Summary of Product characteristics) NPP (Named Patient Product), translated from German 2011, ALK-Albello.
68. Alustal-SmPC of the Swiss Drug Compendium, translated from the Swiss SmPC (Summary of Product Characteristics) 2010, ALK-Albello.
69. ALK-Abello product catalogue 2012, http://www.alk-abello.com/US/products/productinformation/Lists/Product%20Catalog/2012%20Product%20Catalog.pdf [accessed 30.04.14].
70. Levy R., Shohat L., Solomon B. Specificity of an anti-aluminium monoclonal antibody toward free and protein-bound aluminium. J Inorg Biochem 1998, 69:159-164.
71. Wheeler A.W., Moran D.M., Robins B.E., Driscoll A. l-Tyrosine as an immunological adjuvant. Int Arch Allergy Appl Immun 1982, 69:113-119.
72. Wheeler A.W., Woroniecki S.R. Immunological adjuvants in allergy vaccines: past, present and future. Allergol Int 2001, 50:295-301.
73. Baldrick P., Richardson D., Wheeler A.W. Review of l-tyrosine confirming its safe human use as an adjuvant. J Appl Toxicol 2002, 22:333-344.
74. Chen J., Pompano R.R., Santiago F.W., Maillat L., Sciammas R., Sun T., et al. The use of self-adjuvanting nanofiber vaccines to elicit high-affinity B cell responses to peptide antigens without inflammation. Biomaterials 2013, 34(34):8776-8785.
75. DuBuske L.M., Frew A.J., Horak Keith P.K., Corrigan C.J., Aberer W., et al. Ultrashort-specific immunotherapy successfully treats seasonal allergic rhinoconjunctivitis to grass pollen. Allergy Asthma Proc 2011, 32(3):239-247.
76. Thermo Catalogue. [accessed 22.04.14]. http://www.thermo.com/eThermo/CMA/PDFs/Articles/articlesFile_18407.pdf%3F.
77. German Research Foundation. [accessed 01.03.14]. http://www.dfg.de/dfg_profil/gremien/senat/gesundheitsschaedliche_arbeitsstoffe/aufbau_kommission/arbeitsgruppen/biologisches_material/index.html.