Pre-Seasonal Treatment With Recombinant Carrier-Based Birch Vaccine Improves Birch Pollen Allergy.
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Khaitov Musa R, Byazrova Maria G, Smolnikov Evgenii V, Turenko Vladislav N, Smirnov Valeriy V, Shilovskii Igor P, Shershakova Nadezhda N, Medunitsyna Ekaterina N, Elisyutina Olga G, Pashenkov Mikhail V, Pasikhov George B, Murugin Vladimir V, Parshina Veronika A, Bolyakina Darya K, Primak Anastasia S, Lapyko Mariya A, Danilycheva Inna V, Schubelko Rosalia V, Tsyvkina Anastasia A, Shartanova Nataliia V, Timoshenko Daria O, Isakova Irina I, Latysheva Tatiana V, Shulzhenko Andrey E, Latysheva Elena A, Kurbacheva Oksana M, Fedenko Elena S, Markova Oksana A, Korotkevich Ilya A, Yan Violetta V, Gavrilova Natalia A, Tikhomirova Mariia V, Shevchenko Ivan V, Agafonova Alena A, Poroshin Gregory N, Kudlay Dmitry A, Filatov Alexander V, Nazarova Evgeniya V, Kruchko Daria S, Goryachev Dmitriy V, Merkulov Vadim A, Ilina Nataliya I, Valenta Rudolf, Skvortsova Veronica I
Аннотация
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).