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.

A Bayesian method for inference of effective connectivity in brain networks for detecting the Mozart effect.

Several studies claim that listening to Mozart music affects cognition and can be used to treat neurological conditions like epilepsy. Research into this Mozart effect has not addressed how dynamic interactions between brain networks, i.e.

Racial and ethnic differences in genetic counseling experiences and outcomes in the United States: A systematic review.

As genetic counseling services expand and reach a wider catchment of the population, there is a critical need to better understand the impact of services on a greater diversity of patients. We conducted a systematic review to evaluate genetic counseling experiences and outcomes among racial and ethnic minorities. Six databases extracted articles published from 2005 to 2019 that assessed genetic counseling participation, knowledge and awareness, motivators, barriers, perceptions, and outcomes for racial and ethnic minority populations in the United States.

Conserved genomic neighborhood is a strong but no perfect indicator for a direct interaction of microbial gene products.

Background: The order of genes in bacterial genomes is not random; for example, the products of genes belonging to an operon work together in the same pathway. The cotranslational assembly of protein complexes is deemed to conserve genomic neighborhoods even stronger than a common function. This is why a conserved genomic neighborhood can be utilized to predict, whether gene products form protein complexes.

The role of race and ethnicity in views toward and participation in genetic studies and precision medicine research in the United States: A systematic review of qualitative and quantitative studies.

Background: Racial/ethnic minority populations in the United States are consistently underrepresented in genetic research. Large-scale public participation is required to ensure discoveries from precision medicine research are applicable to everyone. To evaluate views toward and facilitators of participation among minority populations in the United States, we conducted a systematic review of literature.

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.

Allergen Immunotherapy Clinical Trial Outcomes and Design: Working Toward Harmonization of Methods and Principles.

Progress has been made in the harmonization of efficacy and safety outcome measures for allergen immunotherapy (AIT) trials, but unresolved issues still remain. Furthermore, there are discrepancies in recommendations from professional medical societies and regulatory agencies regarding requirements for AIT trials. In this article, we reviewed published recommendations and current data from recent clinical trials, as well as the criteria applied by regulatory authorities for approval of AIT products, to provide updated considerations for conducting phase 3 AIT trials.

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.

Similar biological activity in skin prick test for Oralair (8200 BAU) and Grazax (6200 BAU) reinforces effective SLIT dosing level.

In Europe, allergen extracts are standardized based on skin prick wheal size in 20-30 allergic subjects. To understand the biological activity of clinically effective Sublingual immunotherapy, we used this method to determine the biological activity of solution and tablet Timothy grass pollen (TIM) extracts, compared to an FDA-approved extract (Reference) of 10 000 BAU/ml. Blinded, quadruplicate skin prick tests with concentrate and three serial half-log dilutions allowed the construction of a semilogarithmic regression line per extract.

Predicting dropout using student- and school-level factors: An ecological perspective.

High school dropout has been associated with negative outcomes, including increased rates of unemployment, incarceration, and mortality. Dropout rates vary significantly depending on individual and environmental factors. The purpose of our study was to use an ecological perspective to concurrently explore student- and school-level predictors associated with dropout for the purpose of better understanding how to prevent it.

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.

NSAIDs can have adverse effects on bone healing.

The science of osteoimmunology, a relatively new field of research, reveals the important interactions between the immune system and skeletal system. Interactions occur between prostaglandin metabolism, inflammatory proteins and bone metabolism. Systemic as well as local sources of inflammation appear to be actively involved in both bone formation and resorption.

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).

Maintenance dosing for sublingual immunotherapy by prominent European allergen manufacturers expressed in bioequivalent allergy units.

Background: Sublingual immunotherapy (SLIT) has become established in Europe, and its efficacy is being evaluated in the United States. The doses used for SLIT in Europe today are difficult to evaluate, because each manufacturer expresses the potency of its extracts differently.

Objectives: To compare in vitro European SLIT maintenance solutions against US licensed standardized allergenic extract concentrates and to determine the monthly SLIT doses delivered expressed in bioequivalent allergy units ([B]AU).

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.

House dust mite sublingual immunotherapy: results of a US trial.

Background: Few trials of sublingual immunotherapy (SLIT) in the United States have been reported.

Objective: This randomized, placebo-controlled feasibility SLIT study compared the safety and physiologic effects of high- versus low-dose Dermatophagoides farinae vaccine.

Methods: Thirty-one D farinae-sensitive adults with allergic rhinitis with or without mild intermittent asthma were eligible for randomization to high-dose maintenance vaccine (n = 10, 4200 allergen units [approximately 70 μg of Der f 1/d]), low-dose maintenance vaccine (n = 10; 60 allergen units [approximately 1 μg of Der f 1/d]), or placebo (n = 11) over 12 to 18 months.

Endotoxin contamination of engineered nanomaterials.

Endotoxin has established health impacts and may be a potential confounding factor in toxicity studies of engineered nanomaterials (ENM). We aimed to characterize endotoxin contamination for a representative set of carbon-based ENM. The established method for quantifying endotoxin relies on its activity in a complex biochemical assay system.