Pollinex® Quattro Ragweed: Safety evaluation of a new allergy vaccine adjuvanted with monophosphoryl lipid A (MPL®) for the treatment of ragweed pollen allergy

Journal of Applied Toxicology

Volumn 27, Issue 4, 2007, Pages 399-409

  Baldrick, Paul ^a   Richardson, Derek ^b   Woroniecki, Stefan R ^b   Lees, Beverley ^b  

^a UK   (United Kingdom)

^b Allergy Therapeutics Ltd   (United Kingdom)

Author keywords

Allergy vaccines; MPL adjuvant; Pollinex Quattro Ragweed; Ragweed pollen; Toxicity studies

Indexed keywords

GLUTARALDEHYDE; MPL; PHOSPHORYL LIPID A; POLLINEX QUATTRO RAGWEED; POLLINEX R; RAGWEED ANTIGEN; TYROSINE; UNCLASSIFIED DRUG; ALLERGEN; DRUG DERIVATIVE; IMMUNOLOGICAL ADJUVANT; LIPID A; PLANT EXTRACT; VACCINE;

ADSORPTION; ANIMAL EXPERIMENT; ARTICLE; CONTROLLED STUDY; DOSE RESPONSE; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERANCE; FEMALE; GENOTOXICITY; INJECTION SITE NECROSIS; MALE; MOUSE; NONHUMAN; POLLEN ALLERGY; PRIORITY JOURNAL; RAGWEED POLLEN; RAT; REVERTANT; TOXICITY TESTING; ANIMAL; CHEMISTRY; DOG; DRUG EFFECT; GENETICS; HAY FEVER; IMMUNOLOGY; INTRACUTANEOUS TEST; INTRAMUSCULAR DRUG ADMINISTRATION; METHODOLOGY; MUTAGEN TESTING; POLLEN; RAGWEED; SALMONELLA TYPHIMURIUM; SPRAGUE DAWLEY RAT; SUBCUTANEOUS DRUG ADMINISTRATION; VACCINATION;

AMBROSIA; ANIMALIA; CANIS FAMILIARIS; MUS; RATTUS;

ACUTE TOXICITY TESTS; ADJUVANTS, IMMUNOLOGIC; ALLERGENS; AMBROSIA; ANIMALS; DOGS; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; INJECTIONS, INTRAMUSCULAR; INJECTIONS, SUBCUTANEOUS; INTRADERMAL TESTS; LIPID A; MALE; MICE; MUTAGENICITY TESTS; PLANT EXTRACTS; POLLEN; RATS; RATS, SPRAGUE-DAWLEY; RHINITIS, ALLERGIC, SEASONAL; SALMONELLA TYPHIMURIUM; TOXICITY TESTS, CHRONIC; VACCINATION; VACCINES;

EID: 34447542505     PISSN: 0260437X     EISSN: 10991263     Source Type: Journal    
DOI: 10.1002/jat.1223     Document Type: Article

References (61)

1. Alving CR. 1993. Lipopolysaccharide, lipid A and liposomes containing lipid A as immunologic adjuvants. Immunobiology 187: 430-446.
2. Arbes SR Jr, Gergen PJ, Elliott L, Zeldin DC. 2005. Prevalences of positive skin test responses to 10 common allergens in the US population: results from the third National Health and Nutrition Examination Survey. J. Allergy Clin. Immunol. 116: 377-383.
3. Baldrick P, Richardson D, Elliott G, Wheeler AW. 2002a. Safety evaluation of monophosphoryl lipid A (MPL®): An immunostimulatory adjuvant. Regul. Toxicol. Pharmacol. 35: 398-413.
4. Baldrick P, Richardson D, Wheeler AW. 2002b. Review of L-tyrosine confirming its safe human use as an adjuvant. J. Appl. Toxicol. 22: 333-344.
5. Baldrick P, Richardson D, Wheeler AW. 2002c. Safety evaluation of a glutaraldehyde modified tyrosine adsorbed housedust mite extract containing monophosphoryl lipid A (MPL®) adjuvant: A new allergy vaccine for dust mite allergy. Vaccine 20: 737-743.
6. Baldrick P, Richardson D, Wheeler AW, Woroniecki SR. 2004. Safety evaluation of a new allergy vaccine containing the adjuvant Monophosphoryl Lipid A (MPL®) for the treatment of grass pollen allergy. J. Appl. Toxicol. 24: 261-268.
7. Bellinghausen I, Metz G, Enk AH, Christmann S, Knop J, Saloga J. 1997. Insect venom immunotherapy induces interleukin 10 production and a Th2- to-Th1 shift, and changes surface marker expression in venom allergic subjects. Eur. J. Immunol 27: 1131-1139.
8. Bonifazi F, Antonicelli I, Bilo MB, Pucci S, Taylor IH, Wheeler AW, Youlten LJF. 1991. Hyposensitization therapy of Parietaria-sensitive patients with a tyrosine-adsorbed allergoid Pollinex Parietaria (Bencard Parietaria). J. Invest. Allergol. Clin. Immunol. 1: 37-44.
9. Bousquet J, Lockey RF, Malling HJ. 1998. WHO Position Paper. Allergen immunotherapy: Therapeutic vaccines for allergic diseases. Allergy 53(suppl): 1-42.
10. Clay M, Urban E. 2005. Specific immunotherapy using pollen allergoids adjuvanted with monophosphoryl lipid A over a three year period shows good efficacy and increased tolerability. Poster presented at British Society for Allergy and Clinical Immunology meeting, July 2005, Loughborough, UK. Abstract. Clin. Exp Allergy 2005; 35: 1411.
11. De Becker G, Moulin V, Pajak B, Bruck C, Francotte M, Thiriart C, Urbain J, Moser M. 2000. The adjuvant monophosphoryl lipid A increases the function of antigen-presenting cells. Int. Immunol. 12: 807-815.
12. Drachenberg KJ, Proll S, Urban E, Woroniecki SR. 2002. Short-term immunotherapy using an allergy vaccine adjuvanted with monophosphoryl lipid A: a post-marketing surveillance study. Int. Rev. Allergol. Clin. Immunol. 8: 219-223.
13. Drachenberg KJ, Proll S, Urban E, Woroniecki SR. 2003. Single-course specific immunotherapy with mixed pollen allergoids: results of a multi-centre study. Allergol. Immunopathol. 31: 77-82.
14. Drachenberg KJ, Wheeler AW, Stuebner P, Horak F. 2001. A well-tolerated grass pollen specific allergy vaccine containing a novel adjuvant, monophosphoryl lipid A reduces allergic symptoms after only four preseasonal injections. Allergy 56: 498-505.
15. Durham SR, Till SJ. 1998. Immunologic changes associated with allergen immunotherapy. J. Allergy Clin. Immunol. 102: 157-164.
16. Ebner C. 1999. Immunological mechanisms operative in allergen-specific immunotherapy. Int. Arch. Allergy Immunol. 119: 1-5.
17. Gherardi RK, Coquet M, Cherin P, Belec L, Moretto P, Dreyfuss PA, Pellissier J-F, Chariot P, Authier F-J. 2001. Macrophagic myofasciitis lesions assess long-term persistence of vaccine-derived aluminium hydroxide in muscle. Brain 124: 1821-1831.
18. Gupta RK, Rost BE, Relyveld E, Siber GR. 1995. Adjuvant properties of aluminium and calcium compounds. Pharm. Biotechnol. 6: 229-248.
19. Hopkins M, Lees BG, Richardson DG, Woroniecki SR, Wheeler AW. 2001. Standardisation of glutaraldehyde-modified tyrosine-adsorbed tree pollen vaccines containing the Th1-inducing adjuvant, monophosphoryl lipid A (MPL®). Allergol. Immunopathol. 29: 245-254.
20. Ismaili J, Rennesson J, Aksoy E, Vekemans J, Vincart B, Amraoui Z, Van Laethem F, Goldman M, Dubois PM. 2002. Monophosphoryl lipid A activates both human dendritic cells and T cells. J. Immunol. 168: 926-932.
21. Jung CM, Prinz JC, Rieber EP, Ring J. 1995. A reduction in allergen induced FcεR2/CD23 expression on peripheral B cells correlates with successful hyposensitisation in grass pollinosis. J. Allergy Clin. Immunol. 95: 77-87.
22. Ko HS, Chen SJ, Jaworska E. 1987. IgG and IgE antibody responses to treatment with modified ragweed tyrosine adsorbate. Ann. Allergy 59: 441-449.
23. Lodmell DL, Ray NB, Ulrich JT, Ewalt LC. 2000. DNA vaccination of mice against rabies virus: effects of the route of vaccination and the adjuvant monophosphoryl lipid A (MPL®). Vaccine 18: 1059-1066.
24. Malling HJ. 2000. Minimising the risks of allergen-specific injection immunotherapy. Drug Saf. 23: 323-332.
25. Martin M, Michalek SM, Katz J. 2003. Role of innate immune factors in the adjuvant activity of monophosphoryl lipid A. Infect. Immun. 71: 2498-2507.
26. Metzger WJ, Dorminey HC, Richerson HB, Weiler JM, Donnelly A, Moran D. 1981. Clinical and immunologic evaluation of glutaraldehyde modified, tyrosine adsorbed short ragweed extract. A double blind, placebo controlled trial. J. Allergy Clin. Immunol. 68: 442-448.
27. Miller ACML. 1976. A comparative trial of hyposensitization in 1973 in the treatment of hay fever using Pollinex and Alavac-P. Clin. Allergy 6: 551-556.
28. Miller ACML, Hart AP, Tees EC. 1976. D. pteronyssinus-tyrosine adsorbate: biological and clinical properties. Acta Allergol. 31: 35-43.
29. Moore A, McCarthy L, Mills KHG. 1999. The adjuvant combination monophosphoryl lipid A and QS21 switches T cell responses induced with a soluble recombinant HIV protein from Th2 to Th1. Vaccine 17: 2517-2527.
30. Moran DM, Wheeler AW. 1976. Chemical modification of crude timothy grass extract. I. Antigenicity and immunogenicity changes following amino group modification. Int. Arch. Allergy Appl. Immunol. 50: 693-708.
31. Moran DM, Wheeler AW, Overall BG, Woroniecki SR. 1977. Chemical modification of crude timothy grass extract. III. The effect of glutaraldehyde-induced aggregation on antigenic and immunogenic properties. Int. Arch. Allergy Appl. Immunol. 54: 315-321.
32. Mothes N, Heinzkill M, Drachenberg KJ, Sperr WR, Krauth MT, Majlesi Y, Semper H, Valent P, Niederberger V, Kraft D, Valenta R. 2003. Allergen-specific immunotherapy with a monophosphoryl lipid A-adjuvanted vaccine: reduced seasonally boosted immunoglobulin E production and inhibition of basophil histamine release by therapy-induced blocking antibodies. Clin. Exp. Allergy 33: 1198-1208.
33. Muehlethaler K, Wuthrich B, Peeters AG, Terki N, Girard JP, Frank E. 1990. Hyposensitization in pollinosis. Results of a 3-year controlled study with 2 depot-allergoid grass pollen extracts: aluminum hydroxide-adsorbed allergoid and tyrosine-adsorbed allergoid. Schweiz. Rundsch. Med. Prax. 79: 430-436.
34. Nagore E, Martinez-Escribano JA, Tato A, Sabater V, Vilata JJ. 2001. Subcutaneous nodules following treatment with aluminium-containing allergen extracts. Eur. J. Dermatol. 11: 138-140.
35. Newland BJ, Lees BG, Wheeler AW. 1999. Advantages of L-tyrosine as a depot adjuvant for formulation of therapeutic allergy vaccines. Poster presented at British Society of Immunology & British Society for Allergy and Clinical Immunology, Joint 7th Annual Conference, Nov-Dec 1999, Harrogate, UK. Immunology 98 (suppl 1): 145.
36. Palmer WR, Balacescu A. 1977. A multi-centre trial of pollen-tyrosine adsorbate. Acta Allergol. 32: 44-57.
37. Puggioni F, Durham SR, Francis JN. 2005. Monophosphoryl lipid A (MPL®) promotes allergen-induced immune response deviation in favour of Th1 responses. Allergy 60: 678-684.
38. Rolland JM, Douglass J, O'Hehir RE. 2000. Allergen immunotherapy: current and new therapeutic strategies. Expert Opin. Investig. Drugs 9: 515-527.
39. Singh M, O'Hagan D. 1999. Advances in vaccine adjuvants. Nat. Biotechnol. 17: 1075-1081.
40. Symington IS, O'Neill D, Kerr JW. 1977. Comparison of a glutaraldehyde-modified pollen-tyrosine adsorbate with an alum-precipitated pollen vaccine in the treatment of hay fever. Clin. Allergy 7: 189-194.
41. Taramarcaz P, Lambelet C, Clot B, Keimer C, Hauser C. 2005. Ragweed (Ambrosia) progression and its health risks: will Switzerland resist this invasion? Swiss Med. Wkly 135: 538-548.
42. Thoelen S, Van Damme P, Mathei C, Leroux-Roels G, Desombere I, Safary A, Vandepapeliere P, Slaoui M, Meheus A. 1998. Safety and immunogenicity of a hepatitis B vaccine formulated with a novel adjuvant system. Vaccine 16: 708-714.
43. Ulrich JT, Myers KR. 1995. Monophosphoryl lipid A as an adjuvant. Past experience and new directions. In Vaccine Design: The Subunit and Adjuvant Approach, Powell MF, Newman MJ (eds). Plenum Press: New York; 495-524.
44. Verdier F, Burnett R, Michelet-habchi C, Moretto P, Fievet-Groyne F, Sauzeat E. 2005. Aluminium assay and evaluation of the local reaction at several time points after intramuscular administration of aluminium containing vaccines in the Cynomolgus monkey. Vaccine 23: 1359-1367.
45. Verstraeten JM, Wheeler AW. 1978. A comparative study of an aqueous grass pollen extract and glutaraldehyde-treated grass pollen-tyrosine adsorbate in the treatment of pollenosis. Clin. Allergy 8: 435-443.
46. Vogel FR, Powell MF. 1995. A compendium of vaccine adjuvant and excipients. Pharm. Biotechnol. 6: 141-228.
47. Von Baehr V, Hermes A, von Baehr R, Scherf H-P, Volk H-D, Fischer von Weikersthal-Drachenberg KJ, Woroniecki S. 2005. Allergoid-specific T-cell reaction as a measure of the immunological response to specific immunotherapy (SIT) with a Th1-adjuvanted allergy vaccine. J. Invest. Allergol. Clin. Immunol. 15: 234-241.
48. Wheeler AW, Jenkins PM, Moran DM. 1976. Chemical modification of crude timothy grass extract. II. Class and specificity of antibodies induced by chemically modified timothy grass pollen extract. Int. Arch. Allergy Appl. Immunol. 50: 709-728.
49. Wheeler AW, Marshall J, Ulrich JT. 2001. A Th1-inducing adjuvant, MPL®, enhances antibody profiles in experimental animals suggesting it has the potential to improve the efficacy of allergy vaccines. Int. Arch. Allergy Immunol. 126: 135-139.
50. Wheeler AW, Moran DM, Robins BE, Driscoll A. 1982. L-Tyrosine as an immunological adjuvant. Int. Arch. Allergy Appl. Immunol. 69: 113-119.
51. Wheeler AW, Woroniecki SR. 2001. Immunological adjuvants in allergy vaccines: past, present and future. Allergol. Int. 50: 295-301.
52. Wheeler AW, Woroniecki SR. 2004. Allergy vaccines: new approaches to an old concept. Expert Opin. Biol. Ther. 4: 1473-1481.
53. White JF, Bernstein DI. 2003. Key pollen allergens in North America. Ann. Allergy Asthma Immunol. 91: 425-435.
54. Wopfner N, Gadermaier G, Egger M, Asero R, Ebner C, Jahn-Schmid B, Ferreira F. 2005. The spectrum of allergens in ragweed and mugwort pollen. Int. Arch. Allergy Immunol. 138: 337-346.
55. Woroniecki SR, Skinner M, Hobden T, Mikhalovska LI. 2005. Immunogenic effects of L-tyrosine compared to alum when combined with monophosphoryl lipid A and a model antigen: preliminary results. Poster presented at European Academy of Allergology and Clinical Immunology (EAACI) meeting, Munich, Germany. Abstract. J. World Allergy Org. 2005; suppl 1: 499.
56. www.allergytherapeutics.com. Positive outcome of pivotal Pollinex® Quattro Ragweed study R204. www.allergytherapeutics.com/cgi-bin/ search.cgi (accessed August 2006).
57. www.emea.eu.int-a. European Medicines Agency: Committee for Medicinal Products for Human Use European Public Assessment Report for Fendrix. www.emea.eu.int/humandocs/PDF/EPAR/fendrix/ 8291305en6.pdf (accessed August 2006).
58. www.emea.eu.int-b. Committee for Proprietary Medicinal Products: Note for Guidance on Preclinical Pharmacological and Toxicological Testing of Vaccines (CPMP/465/95, operational since 1998). www.emea.eu.int/pdfs/human/swp/046595en. pdf (accessed August 2006).
59. www.hc-sc.ca. Health Canada Drug Product Database: Pollinex R. www.hc-sc.gc.ca/drugs2/product/p3409.html (accessed August 2006).
60. www.pslgroup.com. Canada approves Melacine therapeutic vaccine for late-stage melanoma. www.pslgroup.com/dg1424a2.htm (accessed August 2006).
61. www.who.int. World Health Organization: Nonclinical Evaluation of Vaccines - WHO Technical Report Series, No. 927, 2005. www. who.int/biologicals/ publications/trs/areas/vaccines/nonclinical_ evaluation/en/index.htm (accessed August 2006).