Manufacturing and Standardizing Allergen Extracts in Europe

2004 ◽  
pp. 458-481
Keyword(s):  
Allergen Extracts

scholarly journals Intralymphatic immunotherapy with tyrosine-adsorbed allergens: a double-blind, placebo-controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Hye Jung Park ◽  
Sae-Hoon Kim ◽  
Yoo Seob Shin ◽  
Chul Hwan Park ◽  
Eun-Suk Cho ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Injection Site ◽  
Symptom Score ◽  
Therapeutic Efficacy ◽  
Controlled Trial ◽  
Life Questionnaire ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Medication Score ◽  
Allergen Extracts

Abstract Background Most previous studies used aluminum hydroxide-absorbed allergen extracts in evaluating the potential therapeutic roles of intralymphatic allergen-specific immunotherapy (ILAIT). In this study, we evaluated the therapeutic efficacy and safety of ILAIT with L-tyrosine-adsorbed allergen extracts of Dermatophagoides farinae, D. pteronyssinus, cat, dog, or mixtures thereof, in patients with allergic rhinitis induced by these allergens. Methods In this randomized, double-blind, placebo-controlled trial, study subjects received three intralymphatic injections of L-tyrosine-adsorbed allergen extracts (active group) or saline (placebo group) at 4-week intervals. Results Although ILAIT reduced daily medication use and skin reactivity to HDM and cat allergens at 4 months after treatment, overall symptom score on a visual analog scale (VAS), sinonasal outcome test-20 (SNOT-20), rhinoconjunctivitis quality of life questionnaire (RQLQ), daily symptom score (dSS), daily medication score (dMS), daily symptom medication score (dSMS), nasal reactivity to HDM allergen, and basophil activity to HDM, cat, and dog allergens at 4 months and 1 year after treatment were similar between the treatment and control groups. Intralymphatic injection was more painful than a venous puncture, and pain at the injection site was the most frequent local adverse event (12.8%); dyspnea and wheezing were the most common systemic adverse events (5.3%). Conclusions ILAIT with L-tyrosine-adsorbed allergen extracts does not exhibit profound therapeutic efficacy in allergic rhinitis and can provoke moderate-to-severe systemic reactions and cause pain at the injection site. Trial registration: clinicaltrials.gov: NCT02665754; date of registration: 28 January 2016

Endotoxin Testing of Allergen Extracts

2009 ◽  
Vol 123 (2) ◽  
pp. S97-S97
Author(s):  
R. Codina ◽  
M.D. Roby ◽  
R.E. Esch
Keyword(s):  
Allergen Extracts

scholarly journals A Highly Sensitive Cell-Based TLR Reporter Platform for the Specific Detection of Bacterial TLR Ligands

2022 ◽  
Vol 12 ◽  
Author(s):  
Katharina Radakovics ◽  
Claire Battin ◽  
Judith Leitner ◽  
Sabine Geiselhart ◽  
Wolfgang Paster ◽  
...  
Keyword(s):  
Limit Of Detection ◽  
Ectopic Expression ◽  
High Sensitivity ◽  
High Specificity ◽  
Reporter System ◽  
Specificity And Sensitivity ◽  
Highly Sensitive ◽  
Definition Of ◽  
The Individual ◽  
Allergen Extracts

Toll-like receptors (TLRs) are primary pattern recognition receptors (PRRs), which recognize conserved microbial components. They play important roles in innate immunity but also in the initiation of adaptive immune responses. Impurities containing TLR ligands are a frequent problem in research but also for the production of therapeutics since TLR ligands can exert strong immunomodulatory properties even in minute amounts. Consequently, there is a need for sensitive tools to detect TLR ligands with high sensitivity and specificity. Here we describe the development of a platform based on a highly sensitive NF-κB::eGFP reporter Jurkat JE6-1 T cell line for the detection of TLR ligands. Ectopic expression of TLRs and their coreceptors and CRISPR/Cas9-mediated deletion of endogenously expressed TLRs was deployed to generate reporter cell lines selectively expressing functional human TLR2/1, TLR2/6, TLR4 or TLR5 complexes. Using well-defined agonists for the respective TLR complexes we could demonstrate high specificity and sensitivity of the individual reporter lines. The limit of detection for LPS was below 1 pg/mL and ligands for TLR2/1 (Pam3CSK4), TLR2/6 (Fsl-1) and TLR5 (flagellin) were detected at concentrations as low as 1.0 ng/mL, 0.2 ng/mL and 10 pg/mL, respectively. We showed that the JE6-1 TLR reporter cells have the utility to characterize different commercially available TLR ligands as well as more complex samples like bacterially expressed proteins or allergen extracts. Impurities in preparations of microbial compounds as well as the lack of specificity of detection systems can lead to erroneous results and currently there is no consensus regarding the involvement of TLRs in the recognition of several molecules with proposed immunostimulatory functions. This reporter system represents a highly suitable tool for the definition of structural requirements for agonists of distinct TLR complexes.

scholarly journals Stability evaluation of house dust mite vaccines for sublingual immunotherapy

2010 ◽  
Vol 75 (1) ◽  
pp. 19-26
Author(s):  
Lidija Burazer ◽  
Katarina Milovanovic ◽  
Tanja Cirkovic-Velickovic ◽  
Marija Gavrovic-Jankulovic
Keyword(s):  
House Dust ◽  
House Dust Mite ◽  
Sublingual Immunotherapy ◽  
Protein Profile ◽  
Binding Potential ◽  
Allergen Specific Immunotherapy ◽  
Sds Page ◽  
Dust Mite ◽  
The Stability ◽  
Allergen Extracts

Allergen-specific immunotherapy with house dust mite (HDM) allergen extracts can effectively alleviate the symptoms of allergic rhinitis and asthma. The efficacy of the immunotherapeutic treatment is highly dependent on the quality of house dust mite vaccines. This study was performed to assess the stability of house dust mite allergen vaccines prepared for sublingual immunotherapy. Lyophilized Dermatophagoides pteronyssinus (Dpt) mite bodies were the starting material for the production of sublingual vaccines in four therapeutic concentrations. The stability of the extract for vaccine production, which was stored below 4 ?C for one month, showed consistence in the protein profile in SDS PAGE. ELISA-inhibition showed that the potencies of Dpt vaccines during a 12 month period were to 65-80 % preserved at all analyzed therapeutic concentrations. This study showed that glycerinated Dpt vaccines stored at 4?C preserved their IgE-binding potential during a 12 month period, implying their suitability for sublingual immunotherapeutic treatment of HDM allergy.

IMMUNOCHEMICAL EFFECTS OF INJECTION THERAPY WITH ALLERGENS BY CUSTOMARY AND INTENSIVE DOSAGE REGIMENS IN CHILDREN

PEDIATRICS ◽  
1972 ◽  
Vol 49 (4) ◽  
pp. 536-546
Author(s):  
C. D. May ◽  
M. Lyman ◽  
R. Alberto ◽  
N. Aduna
Keyword(s):  
Clinical Trials ◽  
Injection Therapy ◽  
Skin Tests ◽  
Protein Nitrogen ◽  
Blocking Antibody ◽  
Dosage Regimens ◽  
Neutralizing Capacity ◽  
Allergen Extracts ◽  
Frequent Measurement

Evaluation of dosage regimens for injection therapy with allergen extracts was undertaken by determination of immunochemical responses. Antigenic release of histamine was used as a means of measuring leukocyte sensitivity to allergens and antigen-neutralizing capacity of serum or "blocking" antibody. Customary dosage regimens providing 190,000 to 265,000 Protein Nitrogen Units of allergen in 2 years, and intensive dosage regimens providing these amounts or more in a few weeks were evaluated in 46 allergic children by frequent measurement of luekocyte sensitivity and antigen-neutralizing capacity of serum. Uninjected subjects were studied simultaneously. With 32 children receiving customary dosage regimens for injection of an allergen extract (Alternaria, ragweed, house dust), increases and decreases in leukocyte sensitivity in those children receiving injections did not differ significantly from others without injections. Modest increases in antigen-neutralizing capacity of serum occurred with injections. With 14 children receiving intensive dosage regimens for injection of the same allergens, much higher titers of antigen-neutralizing capacity in the serum could be achieved, but little net change in leukocyte sensitivity was observed, except for one case in which leukocytes became desensitized. In no case did intradermal skin tests with the allergens become negative, meaning the children were not desensitized. The dosage regimens used for injection of the allergens tested did not evoke immunochemical responses which encourage one to undertake extensive clinical trials.

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