Conditions

Keywords

HypersensitivityBirch Pollen AllergySeasonal AllergyBirch PollenImmune System DiseasesRespiratory Tract DiseasesRespiratory Hypersensitivity

Outcome Measures

Primary Outcomes (3)

Daily Symptom Score (dSS)
According to the dSS scale, the patient will need to assess the presence and severity of 4 symptoms of AR (itchy nose, sneezing, runny nose and nasal congestion) and 2 symptoms of AK (itchy eyes/redness of the eyes and lacrimation) on a 3-point scale, where 0 - no symptoms, 1-mild symptoms (the sign/symptom is clearly present, but causes minimal anxiety; easily tolerated), 2 - moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 - severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). 4 nasal and 2 conjunctival symptoms to be assessed from 0 to 3 score each. Total (dayli) symptoms score: 0-3 (max score is 3, i.e. 18 points/divided by 6 symptoms): 0 - no symptoms, 3 - severe symptoms.
Up to 3 months after the end of treatment.
Daily Medication Score (dMS)
The use of the following medications that can be used to relieve symptoms of allergic rhinitis and allergic conjunctivitis will need to be evaluated by the patient * Non-sedative H1-antihistamines (H1A) for oral and / or topical use (eyes or nose) = 1 point; * Intranasal corticosteroids (InCS) with / without H1A = 2 points; * Oral corticosteroids with / without InKS, with / without H1A = 3 points. Points are not added up, and the maximum score is set. Thus, the minimum dMS value is 0 and means no need for medication, and the maximum dMS value is 3 and means the need for third-line medications).
Up to 3 months after the end of treatment.

Secondary Outcomes (5)

36-Item Short Form Health Survey (36-SF)
Day 0, week 16 (end of treatment) and up to 3 months after the end of treatment.
Severity of allergic rhinitis symptoms on a Visual-analog scale (VAS)
Uo to 3 months after the end of therapy.
Antibody level to the Betv1, Mald1 and PreS antigens.
Day 1, week 8, week 16 and up to 3 months after the end of treatment.
Percentage of the CD3+CD69+ T-cells
Day 1, week 8, week 16 and up to 3 months after the end of treatment.
Cytokines level
Day 1, week 8, week 16 and up th 3 months after the end of treatment.

Study Arms (4)

GNR-127, 20 mcg

EXPERIMENTAL

GNR-127, 20 mcg, suspension for subcutaneous administration, 0.5 ml / dose

Biological: GNR-127, 20 mcg

GNR-127, 40 mcg

EXPERIMENTAL

GNR-127 40 mcg, suspension for subcutaneous administration, 0.5 ml / dose

Biological: GNR-127, 40 mcg

GNR-127, 80 mcg

EXPERIMENTAL

GNR-127 80 mcg, suspension for subcutaneous administration, 0.5 ml / dose

Biological: GNR-127, 80 mcg

Interventions

GNR-127, 20 mcgBiological

GNR-127, 20 mcg in 0.5 ml administered 5 times every 4 weeks

Also known as: Recombinant antigen protein carries a birch pollen allergen [BET V 1]

GNR-127, 20 mcg

GNR-127, 40 mcgBiological

GNR-127, 40 mcg in 0.5 ml administered 5 times every 4 weeks

Also known as:

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Having written informed consent to participate in the study obtained from the patient prior to the start of any procedures related to the study.
Men and women aged 18-55 years at the time of signing the informed consent.

Sponsors & Collaborators

AO GENERIUM
Industrylead

Study Sites (1)

National Research Center - Institute of Immunology Federal Medical-Biological Agency

Moscow, 115522, Russia

Related Publications (1)

Khaitov MR, Byazrova MG, Smolnikov EV, Turenko VN, Smirnov VV, Shilovskii IP, Shershakova NN, Medunitsyna EN, Elisyutina OG, Pashenkov MV, Pasikhov GB, Murugin VV, Parshina VA, Bolyakina DK, Primak AS, Lapyko MA, Danilycheva IV, Schubelko RV, Tsyvkina AA, Shartanova NV, Timoshenko DO, Isakova II, Latysheva TV, Shulzhenko AE, Latysheva EA, Kurbacheva OM, Fedenko ES, Markova OA, Korotkevich IA, Yan VV, Gavrilova NA, Tikhomirova MV, Shevchenko IV, Agafonova AA, Poroshin GN, Kudlay DA, Filatov AV, Nazarova EV, Kruchko DS, Goryachev DV, Merkulov VA, Ilina NI, Valenta R, Skvortsova VI. Pre-Seasonal Treatment With Recombinant Carrier-Based Birch Vaccine Improves Birch Pollen Allergy. Allergy. 2026 Sep 4. doi: 10.1111/all.70504. Online ahead of print.
PMID: 42695588RESULT

MeSH Terms

Conditions

Rhinitis, Allergic, SeasonalHypersensitivityImmune System DiseasesRespiratory Tract DiseasesRespiratory Hypersensitivity

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesOtorhinolaryngologic DiseasesHypersensitivity, Immediate

Study Officials

Oksana A. Markova, MD
STUDY CHAIR

A Clinical Trial for Evaluation of Efficacy, Safety and Immunogenicity of GNR-127 (Recombinant ABP Antigen Protein Which Carries a Birch Pollen Allergen [BET V 1] and an Apple Allergen [MAL D 1]) in Patients With Birch Pollen Allergic Rhinitis.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (5)

Study Arms (4)

GNR-127, 20 mcg

GNR-127, 40 mcg

GNR-127, 80 mcg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Placebo

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (5)

Study Arms (4)

GNR-127, 20 mcg

GNR-127, 40 mcg

GNR-127, 80 mcg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Placebo

You may not qualify if:

Data Sharing

Source record

Locations