Document Detail


Standardisation of glutaraldehyde-modified tyrosine-adsorbed tree pollen vaccines containing the Th1-inducing adjuvant, monophosphoryl lipid A (MPL).
MedLine Citation:
PMID:  11834183     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: a new range of allergy vaccines has been developed by the introduction of a relatively new Th1-inducing adjuvant known as 3-deacylated monophosphoryl lipid A (MPL). MPL adjuvant is of natural origin, derived from the lipopolysaccharide of Salmonella minnesota R595. This adjuvant is incorporated in a glutaraldehyde-modified pollen extract adsorbed to L-tyrosine (Pollinex Quattro). A major potential benefit provided by MPL adjuvant is the promotion of a Th1 response which enhances the efficacy of allergy vaccination and can consequently allow a reduction in the number of injections required for treatment. The standardisation of Pollinex Quattro tree pollen allergy vaccine is described and we include details of some innovative analytical procedures. METHODS AND RESULTS: an essential feature of the analytical strategy is the assay of the MPL adjuvant using a recently developed HPLC technique. The adjuvant has a complex chemical structure and the analysis is illustrated in detail. We give a full picture of the vaccine standardisation by describing biochemical and immunological characterisation of the allergen extract, together with some brief manufacturing details. CONCLUSIONS: a high overall level of standardisation is illustrated by a number of different tests applied to all stages of vaccine manufacture. Tree pollen allergen potency is measured following the pollen extraction, chemical modification and formulation as a tyrosine adsorbate. Good batch-to-batch reproducibility is shown. The HPLC assay for MPL adjuvant showed high quality resolution which did not vary when measuring raw material or when incorporated in the vaccine and the technically complex assay is shown to be reliable.
Authors:
M Hopkins; B G Lees; D G Richardson; S R Woroniecki; A W Wheeler
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Publication Detail:
Type:  Comparative Study; Journal Article    
Journal Detail:
Title:  Allergologia et immunopathologia     Volume:  29     ISSN:  0301-0546     ISO Abbreviation:  Allergol Immunopathol (Madr)     Publication Date:    2001 Nov-Dec
Date Detail:
Created Date:  2002-02-08     Completed Date:  2002-04-08     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0370073     Medline TA:  Allergol Immunopathol (Madr)     Country:  Spain    
Other Details:
Languages:  eng     Pagination:  245-54     Citation Subset:  IM    
Affiliation:
Allergy Therapeutics Ltd, West Sussex, UK.
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MeSH Terms
Descriptor/Qualifier:
Adjuvants, Immunologic*
Adsorption
Allergens / drug effects,  immunology,  therapeutic use*
Chromatography, High Pressure Liquid
Cross-Linking Reagents / pharmacology
Electrophoresis, Polyacrylamide Gel
Glutaral / pharmacology
Immunoelectrophoresis, Two-Dimensional
Isoelectric Focusing
Lipid A / analogs & derivatives*,  chemistry,  immunology*
Molecular Structure
Plant Extracts / immunology,  standards*
Pollen / drug effects,  immunology*
Quality Control
Reproducibility of Results
Rhinitis, Allergic, Seasonal / prevention & control*
Th1 Cells / immunology*
Trees*
Tyrosine
Vaccines / standards*
Chemical
Reg. No./Substance:
0/Adjuvants, Immunologic; 0/Allergens; 0/Cross-Linking Reagents; 0/Lipid A; 0/Plant Extracts; 0/Vaccines; 0/monophosphoryl lipid A; 111-30-8/Glutaral; 55520-40-6/Tyrosine; 56996-84-0/Pollinex

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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