Trial reportThe Journal of allergy and clinical immunology2018
Safety and efficacy of immunotherapy with the recombinant B-cell epitope-based grass pollen vaccine BM32.
Trial report in The Journal of allergy and clinical immunology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 51 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
51 citing papers in PubMed.
- Maternal allergen-specific IgG might protect the child against allergic sensitization.The Journal of allergy and clinical immunology · 2019Trial
- Engineering tolerogenic mRNA-LNPs for allergen-specific immune reprogramming in pollen allergy.Materials today. Bio · 2026Article
- Recent advances in allergen immunotherapy.Chinese medical journal · 2026Review
- Nanomaterials for Allergy Diagnosis and Treatment: Advances, Opportunities and Translational Challenges.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Review
- Discovery of tumor antigens in renal cell carcinoma and prospects for clinical application.Frontiers in immunology · 2026Review
- Long-Term Administration of BTH2 Hypoallergenic Vaccine Candidate Induces Hallmarks of Allergen Immunotherapy in Murine Model ofBiomedicines · 2025Article
- Recombinant Hypoallergenic Cat Allergy Vaccines.Allergy · 2025Article
- B-cell epitope peptide immunotherapy alleviates chitin-binding protein-induced type 2 airway inflammation in a Blomia tropicalis-murine model.Respiratory research · 2025Article
- Advances in Allergen Immunotherapy and Safety.Vaccines · 2025Review
- Role of allergen immunotherapy and biologics in allergic diseases.Current opinion in immunology · 2024Review
- Novel Approaches to Allergen Immunotherapy for Respiratory Allergies.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Article
- Heterogenous Induction of Blocking Antibodies against Ragweed Allergen Molecules by Allergen Extract-Based Immunotherapy Vaccines.Vaccines · 2024Article
- Identification, Characterization, Cloning, and Cross-Reactivity of Zan b 2, a Novel Pepper Allergen of 11S Legumin.Journal of agricultural and food chemistry · 2024Article
- A Novel Bionebulizer Approach to Study the Effects of Natural Mineral Water on a 3D In Vitro Nasal Model from Allergic Rhinitis Patients.Biomedicines · 2024Article
- Novel adjuvants in allergen-specific immunotherapy: where do we stand?Frontiers in immunology · 2024Review
- Allergenic Activity of Individual Cat Allergen Molecules.International journal of molecular sciences · 2023Article
- Peptide immunotherapy for aeroallergens.Allergy and asthma proceedings · 2023Article
- Allergen immunotherapy: past, present and future.Nature reviews. Immunology · 2023Review
- IgE and IgG4 Epitopes of Dermatophagoides and Blomia Allergens before and after Sublingual Immunotherapy.International journal of molecular sciences · 2023Article
Corrections and comments
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Authors and funding
23 authors.
Funding
Abstract
backgroundBM32 is a grass pollen allergy vaccine based on recombinant fusion proteins consisting of nonallergenic peptides from the IgE-binding sites of the 4 major grass pollen allergens and the hepatitis B preS protein.
objectiveWe sought to study the safety and clinical efficacy of immunotherapy (allergen immunotherapy) with BM32 in patients with grass pollen-induced rhinitis and controlled asthma.
methodsA double-blind, placebo-controlled, multicenter allergen immunotherapy field study was conducted for 2 grass pollen seasons. After a baseline season, subjects (n = 181) were randomized and received 3 preseasonal injections of either placebo (n = 58) or a low dose (80 μg, n = 60) or high dose (160 μg, n = 63) of BM32 in year 1, respectively, followed by a booster injection in autumn. In the second year, all actively treated subjects received 3 preseasonal injections of the BM32 low dose, and placebo-treated subjects continued with placebo. Clinical efficacy was assessed by using combined symptom medication scores, visual analog scales, Rhinoconjunctivitis Quality of Life Questionnaires, and asthma symptom scores. Adverse events were graded according to the European Academy of Allergy and Clinical Immunology. Allergen-specific antibodies were determined by using ELISA, ImmunoCAP, and ImmunoCAP ISAC.
resultsAlthough statistical significance regarding the primary end point was not reached, BM32-treated subjects, when compared with placebo-treated subjects, showed an improvement regarding symptom medication, visual analog scale, Rhinoconjunctivitis Quality of Life Questionnaire, and asthma symptom scores in both treatment years. This was accompanied by an induction of allergen-specific IgG without induction of allergen-specific IgE and a reduction in the seasonally induced increase in allergen-specific IgE levels in year 2. In the first year, more grade 2 reactions were observed in the active (n = 6) versus placebo (n = 1) groups, whereas there was almost no difference in the second year.
conclusionsInjections of BM32 induced allergen-specific IgG, improved clinical symptoms of seasonal grass pollen allergy, and were well tolerated.
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