Safety evaluation of a new allergy vaccine containing the adjuvant monophosphoryl lipid A (MPL) for the treatment of grass pollen allergy.

Abstract	A novel allergy vaccine (Pollinex Quattro) has been developed for the prevention or relief of allergic symptoms caused by a variety of pollens. Within this range, the grass pollen allergy vaccine contains extracts of 12 grass pollens and rye cereal (all chemically modified by glutaraldehyde) that are adsorbed onto L-tyrosine with addition of the immunostimulatory adjuvant monophosphoryl lipid A (MPL). A specific preclinical safety testing strategy was developed to support clinical use, comprising single-dose toxicity, repeat-dose toxicity and local tolerance studies. Dose levels of up to 0.5 ml per animal (mouse) and up to 1.0 ml per animal (rat and rabbit) were used with vaccines containing 2000 or 12 000 standardized units (SU) ml(-1) of grass pollen allergoids, 50 micro g ml(-1) of MPL adjuvant and 20 mg ml(-1) of tyrosine. Overall, the product showed no toxicological findings of significance at levels greatly in excess of those proposed for clinical use. A not unexpected, but relatively minor, immunostimulatory effect was seen following repeated dosing (once weekly for 3 weeks) at 1.0 ml per rat.
Authors	Paul Baldrick, Derek Richardson, Alan W Wheeler, Stefan R Woroniecki
Journal	Journal of applied toxicology : JAT (J Appl Toxicol) 2004 Jul-Aug Vol. 24 Issue 4 Pg. 261-8 ISSN: 0260-437X [Print] England
PMID	15300713 (Publication Type: Journal Article)
Copyright	Copyright 2004 John Wiley & Sons, Ltd.
Chemical References	Adjuvants, Immunologic Allergens Antigens, Plant Lipid A Plant Extracts Vaccines Parietaria judaica pollen monophosphoryl lipid A
Topics	Adjuvants, Immunologic (chemistry) Allergens (chemistry, therapeutic use, toxicity) Animals Antigens, Plant (therapeutic use) Drug Evaluation, Preclinical Female Hypersensitivity (immunology, prevention & control) Injections, Intraperitoneal Injections, Subcutaneous Lipid A (analogs & derivatives, chemistry) Male Mice Mice, Inbred Strains Plant Extracts (chemistry, toxicity) Pollen (immunology) Rabbits Rats Rats, Inbred Strains Skin Tests Toxicity Tests Toxicity Tests, Acute Toxicity Tests, Chronic Vaccines (chemistry, toxicity)

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