The Clinical Relevance of Pollen Versus Fungal Spores in Allergic Diseases.

Pollen and fungal spores are associated with seasonal and perennial allergies. However, most scientific literature thus far suggests that pollen allergy is more clinically relevant than fungal allergy. Several environmental and biological factors and the difficulty in producing reliable fungal extracts account for this.

Understanding differences in allergen immunotherapy products and practices in North America and Europe.

Allergen immunotherapy (AIT) is thought to be clinically effective and safe in treating allergic rhinitis, asthma, and stinging insect allergy in Europe and North America. However, there are intercontinental differences in AIT therapeutic products in terms of their application and regulation. In North America unmodified standardized and nonstandardized aqueous aeroallergen extracts are approved and used almost exclusively for subcutaneous immunotherapy, whereas more product options are available in Europe, including adsorbed allergens, chemically modified allergens, or both.

Fungal raw materials used to produce allergen extracts.

Objective: To review the topic of fungal raw materials used for the production of allergen extracts and the associated challenges and highlight candidate areas for development before standardized fungal allergen extracts can be commercially produced.

Data Sources: A PubMed search was performed using focused keywords and combined with a review of regulatory documents and industry guidelines. Several books on mycology also were consulted.

Mite allergen extracts and clinical practice.

Objective: To provide physicians, researchers, and other interested health care professionals with information about how mite source materials and allergen extracts are manufactured, including the critical process parameters that can affect the final composition of allergenic extracts available for clinical use.

Data Sources: A PubMed search was performed using focused keywords combined with relevant regulatory documents and industry guidelines.

Study Selections: The information obtained through literature and specialized books was evaluated and combined with the personal expertise and experience of the authors.

Preservation of epithelial cell barrier function and muted inflammation in resistance to allergic rhinoconjunctivitis from house dust mite challenge.

Background: An emerging paradigm holds that resistance to the development of allergic diseases, including allergic rhinoconjunctivitis, relates to an intact epithelial/epidermal barrier during early childhood. Conceivably, the immunologic and genomic footprint of this resistance is preserved in nonatopic, nonallergic adults and is unmasked during exposure to an aeroallergen.

Objective: The aim of this study was to obtain direct support of the epithelial/epidermal barrier model for allergic rhinoconjunctivitis.

Randomized, double-blind, placebo-controlled trial of standardized ragweed sublingual-liquid immunotherapy for allergic rhinoconjunctivitis.

Background: Sublingual immunotherapy with liquid extracts provides an appealing alternative to subcutaneous immunotherapy for the treatment of allergic rhinoconjunctivitis (ARC), but a lack of robust evidence has deterred its use in North America.

Objective: To determine the efficacy and tolerability of standardized glycerinated short ragweed sublingual allergen immunotherapy liquid (RW-SAIL) extract in subjects with ragweed-related ARC.

Methods: This phase 3, randomized, placebo-controlled trial was conducted in North America.

Immunotherapy preparation guidelines, rules, and regulation.

Allergen immunotherapy has been used to treat allergic diseases for more than 100 years. In the U.S.

Intra and inter-laboratory reproducibility of a monoclonal antibody cocktail based ELISA for detection of allergen specific IgE in dogs: proficiency monitoring of macELISA in six laboratories.

The purpose of this study was to evaluate the reproducibility of results yielded using a monoclonal antibody based ELISA for detection of allergen specific IgE when run in six separate affiliated laboratories. On two separate occasions, duplicate samples of 15 different sera pools were independently evaluated by each laboratory in a single blinded fashion. The average intra-assay variance among reactive assay calibrators in all laboratories was 6.

Allergen stabilities and compatibilities in mixtures of high-protease fungal and insect extracts.

Background: Current practice guidelines state that protease-rich fungal and insect extracts can be combined when preparing immunotherapy vaccines, but data supporting the stability of allergens in these mixtures have not been reported.

Objective: To determine the stabilities and compatibilities of Alternaria alternata and German cockroach allergens in mixtures with other high-protease fungal and insect (cockroach, imported fire ant) extracts at final extract concentrations consistent with injection dose targets for maintenance immunotherapy.

Methods: Mixtures containing Alternaria, German cockroach, and other fungal and insect extracts frequently included in immunotherapy vaccines were analyzed by a combination of quantitative analyses (enzyme-linked immunosorbent assays for multiallergen immunoglobulin E [IgE]-binding potency, major Alternaria allergen Alt a 1, and major German cockroach allergens Bla g 1 and Bla g 2) and qualitative methods (immunoblotting).

Allergen immunotherapy practice in the United States: guidelines, measures, and outcomes.

To discuss recent issues pertinent to allergen immunotherapy practice in the United States. Allergen extract preparation guidelines, updated allergen immunotherapy practice parameter (AIPP) guidelines, and evolving trends in how immunotherapy outcomes will be measured and assessed. Allergen extract preparation guidelines have been established by 2 entities: the US Pharmacopeia and an American Academy of Allergy, Asthma, and Immunology/American College of Allergy, Asthma, and Immunology/Joint Council of Allergy, Asthma, and Immunology Joint Task Force.

Allergen compatibilities in extract mixtures.

Stability studies with a few well-characterized allergen extracts have yielded useful information about the shelf-life of these products stored under various conditions. The development of validated stability-indicating tests and their clinical verification remains a fundamental challenge for extending this information to cover more products. This challenge becomes even greater for evaluations of more complex, multiextract mixtures that are used in clinical practice.

Novel nasal secretion collection method for the analysis of allergen specific antibodies and inflammatory biomarkers.

Background: The analysis of immunological markers in nasal secretions provides valuable information for studying nasal mucosa diseases and monitoring immunotherapy and immunity to vaccines administered locally. However, the concentration of biomarkers is highly variable in nasal secretions because of the diversity of collection methods. A nasal secretion collection device was developed to increase detectability of the assay, standardize the sampling technique, eliminate unknown dilution factor, and minimize analyte loss during the sample processing.

Sublingual immunotherapy in patients with allergic rhinoconjunctivitis caused by ragweed pollen.

Background: Specific allergen immunotherapy is most often delivered subcutaneously, but sublingual immunotherapy may confer greater benefit in terms of tolerability and safety, accessibility, and improved antigen delivery.

Objective: This randomized, double-blind, placebo-controlled trial was conducted to identify a safe and effective maintenance dose range of sublingual standardized glycerinated short ragweed pollen extract in adults with ragweed-induced rhinoconjunctivitis.

Methods: In May 2006, a total of 115 patients with ragweed-induced rhinoconjunctivitis were randomly allocated to placebo (n = 40), medium-dose extract (4.

Stability and mixing compatibility of dog epithelia and dog dander allergens.

Background: Little information or data are available concerning the stability and compatibility of dog epithelia and dog dander allergens.

Objective: To determine the immunochemical reactivities of commercial, nonstandardized dog epithelia and dog dander extracts after exposures to various temperatures or after mixing with high-protease fungal and cockroach extracts at concentrations recommended for maintenance immunotherapy (IT) injections.

Methods: Quantitative enzyme-linked immunosorbent assay and qualitative (immunoblot) analyses were performed to compare specific compositional changes with total or individual allergen activities.

Performance characteristics of a monoclonal antibody cocktail-based ELISA for detection of allergen-specific IgE in dogs and comparison with a high affinity IgE receptor-based ELISA.

The purpose of this study was to define the operational and performance characteristics of a commercially available monoclonal antibody based (mac) ELISA for detection of allergen-specific IgE in dogs. The average intra-assay variance over 1 year was 9.7% (range 2.

Allergen source materials: state-of-the-art.

A variety of positive outcomes can be realized from validation and risk management activities (see Table 4). They are dependent on the participation of multiple functional groups including the quality unit, regulatory and legal affairs, engineering and production operations, research and development, and sales and marketing. Quality risk management is receiving increased attention in the area of public health, pharmacovigilance, and pharmaceutical manufacturing.

Sublingual-oral administration of standardized allergenic extracts: phase 1 safety and dosing results.

Background: European studies provide a preponderance of evidence for sublingual allergen immunotherapy (SLIT) safety and efficacy, but they use allergen products that differ from those expected to be approved in the United States.

Objective: To determine the safety and tolerability of 4 US-licensed standardized SLIT allergenic extracts.

Methods: Adults 18 to 50 years old with allergic rhinitis with or without asthma due to timothy grass pollen, short ragweed pollen, house dust mite, or cat hair allergy completed a single-session dose escalation followed by an 8-week, open-label daily course of SLIT.

Sublingual immunotherapy.

Purpose Of Review: Sublingual immunotherapy is an established treatment option for allergic rhinitis in many European countries, but it is not approved in the United States and is considered investigational. Sublingual immunotherapy has received increasing attention in the United States as an alternative to subcutaneous immunotherapy for the treatment of allergic rhinitis and possibly asthma.

Recent Findings: Evidence for the safety and efficacy of sublingual immunotherapy is accumulating.

Assessment of cross-reactivity among five species of house dust and storage mites.

In vitro cross-reactivity among two house dust (Dermatophagoides farinae, D. pteronyssinus) and three storage (Acarus siro, Tyrophagus putrescentiae, Lepidoglyphus destructor) mites was examined in 20 mite-sensitive dogs with natural occurring atopic dermatitis (group A), 13 high-IgE beagles experimentally sensitized to D. farinae (group B), and five healthy beagles (group C).