Pre‐Seasonal Treatment With Recombinant Carrier‐Based Birch Vaccine Improves Birch Pollen Allergy

BACKGROUND: We have recently reported the preclinical characterization of a recombinant birch pollen allergy vaccine based on a fusion protein, AB-PreS, consisting of allergen-derived peptides fused to the hepatitis B virus (HBV)-derived PreS surface protein as immunological carrier. OBJECTIVE: To investigate in a clinical study the usefulness of the AB-PreS vaccine, termed GNR-127, for allergen-specific immunotherapy of birch pollen allergy. METHODS: Stage 1 of the study, an open-label Phase I study, determined among three doses (20 μg: n = 6; 40 μg: n = 6; 80 μg: n = 6) administered as Aluminum-hydroxide-adsorbed vaccines subcutaneously five times in monthly intervals, the highest tolerated doses. In the following Stage 2, randomized patients (placebo: n = 45; 40 μg: n = 43; 80 μg: n = 44) received in a single-blind, placebo-controlled Phase II study monthly up to five pre-seasonal injections. Safety monitoring followed the Medical Dictionary for Regulatory Activities (MedDRA); efficacy parameters were determined according to the European Academy for Allergy and Clinical Immunology (EAACI) guidelines; allergen-specific antibodies and basophil sensitivity were determined by ELISA and basophil activation testing, respectively. RESULTS: A dose-dependent reduction of the combined symptom medication score (CSMS) (40 μg: 17.41%; 80 μg: 24.13%) over placebo was observed which was significant for the 80 μg group and accompanied by the strongest induction of Bet v 1-specific IgG (median 20-fold increase) and a blunting of the seasonally boosted IgE response and basophil sensitivity. The vaccine showed an acceptable safety profile despite high administered doses. CONCLUSION: A pre-seasonal course of 5 monthly injections of GNR-127 80 μg improved symptoms of birch pollen allergy accompanied by a robust Bet v 1-specific IgG response, paving the road for a Phase III efficacy study. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT07155499).

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Journal
Allergy
Published
2026-09-04
DOI
https://doi.org/10.1111/all.70504
Primary Topic
Allergic Rhinitis and Sensitization
Type
article
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0.00
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article

Pre‐Seasonal Treatment With Recombinant Carrier‐Based Birch Vaccine Improves Birch Pollen Allergy

D.А. Kudlаy, Vladimir V. Murugin, E S Fedenko, И. В. Шевченко et al.
Allergy
Allergic Rhinitis and Sensitization
article

Pre‐Seasonal Treatment With Recombinant Carrier‐Based Birch Vaccine Improves Birch Pollen Allergy

D.А. Kudlаy, Vladimir V. Murugin, E S Fedenko, И. В. Шевченко, Ekaterina N Medunitsyna, Nadezda N. Shershakova, Natalia А. Gavrilova, O G Elisyutina, A E Shulzhenko, Ilya A. Korotkevich, О. А. Markova, Anastasia S. Primak, D.S. Kryuchko, Evgeniya V. Nazarova, V. N. Turenko, Т В Латышева, Rudolf Valenta, Alexander Filatov, Musa Khaitov, Maria G. Byazrova, О М Курбачева, Elena A. Latysheva, В. И. Скворцова, I I Isakova, Evgenii Smolnikov, Мikhail Pashenkov, Daria O. Timoshenko, Darya K. Bolyakina, G.B. Pasikhov, Smirnov Vv, Veronika A. Parshina, Rosalia V. Schubelko, И П Шиловский, Inna V. Danilycheva, Vadim A. Merkulov, Dmitriy V. Goryachev, Mariia V. Tikhomirova, Nataliya I. Ilina, Alena A. Agafonova, Mariya A. Lapyko, Gregory N. Poroshin, Anastasia A. Tsyvkina, Nataliia V. Shartanova, Violetta V. Yan
article en

Abstract

BACKGROUND: We have recently reported the preclinical characterization of a recombinant birch pollen allergy vaccine based on a fusion protein, AB-PreS, consisting of allergen-derived peptides fused to the hepatitis B virus (HBV)-derived PreS surface protein as immunological carrier. OBJECTIVE: To investigate in a clinical study the usefulness of the AB-PreS vaccine, termed GNR-127, for allergen-specific immunotherapy of birch pollen allergy. METHODS: Stage 1 of the study, an open-label Phase I study, determined among three doses (20 μg: n = 6; 40 μg: n = 6; 80 μg: n = 6) administered as Aluminum-hydroxide-adsorbed vaccines subcutaneously five times in monthly intervals, the highest tolerated doses. In the following Stage 2, randomized patients (placebo: n = 45; 40 μg: n = 43; 80 μg: n = 44) received in a single-blind, placebo-controlled Phase II study monthly up to five pre-seasonal injections. Safety monitoring followed the Medical Dictionary for Regulatory Activities (MedDRA); efficacy parameters were determined according to the European Academy for Allergy and Clinical Immunology (EAACI) guidelines; allergen-specific antibodies and basophil sensitivity were determined by ELISA and basophil activation testing, respectively. RESULTS: A dose-dependent reduction of the combined symptom medication score (CSMS) (40 μg: 17.41%; 80 μg: 24.13%) over placebo was observed which was significant for the 80 μg group and accompanied by the strongest induction of Bet v 1-specific IgG (median 20-fold increase) and a blunting of the seasonally boosted IgE response and basophil sensitivity. The vaccine showed an acceptable safety profile despite high administered doses. CONCLUSION: A pre-seasonal course of 5 monthly injections of GNR-127 80 μg improved symptoms of birch pollen allergy accompanied by a robust Bet v 1-specific IgG response, paving the road for a Phase III efficacy study. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT07155499).

Allergy
Peoples' Friendship University of Russia (RU), Sechenov University (RU), Pirogov Russian National Research Medical University (RU), Gentherm (United States) (US), Institute of Immunology and Physiology (RU), Ministry of Health of the Russian Federation (RU), Karl Landsteiner University of Health Sciences (AT), Federal Medical-Biological Agency (RU), Medical University of Vienna (AT), Thermo Fisher Scientific (Norway) (NO)
Good health and well-being
Openalex Percentile: Top 13%
Allergic Rhinitis and Sensitization
DOIOpen Access PDFOpenAlex
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