PollenVax Subcutaneous Immunotherapy for Mugwort Pollen-Induced Allergic Rhinitis

NCT07563439 | Not Yet Recruiting Phase 2

• 2 other identifiers: POL-II-2026BR25293305
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effectiveness and safety of PollenVax, a subcutaneous allergen immunotherapy (SCIT) drug developed for the treatment of allergic rhinitis and asthma caused by mugwort (Artemisia vulgaris) pollen. PollenVax contains a recombinant form of Art v 1 - the major mugwort pollen allergen - combined with the adjuvant Montanide ISA-51. It is the first-in-class product of this type designed for an ultra-short treatment course. This is a randomized, double-blind, placebo-controlled Phase II study. Participants will be adults aged 18-65 years diagnosed with moderate-to-severe mugwort pollen-induced allergic rhinitis confirmed by skin prick test and/or specific IgE testing. A total of 138 participants will be randomly assigned to one of three groups: placebo, PollenVax at a cumulative dose of 22 µg of recombinant Art v 1, or PollenVax at 44 µg, administered as four weekly subcutaneous injections. The primary efficacy outcome is the Combined Symptom and Medication Score (CSMS) during the peak mugwort pollen period (PGPP). Safety and tolerability outcomes are co-primary endpoints, assessed throughout the study. Secondary outcomes include daily symptom scores, quality of life (RQLQ/AQLQ), visual analogue scale for rhinoconjunctivitis discomfort, skin prick test reactivity, and immunological markers (Art v 1-specific IgE and IgG). The study is conducted at a single clinical center (Medcenter-Rakhat, Almaty, Kazakhstan). Sponsor: Kazakh National Agrarian Research University (KazNARU).

Conditions

Rhinitis Allergic

Keywords

PollenVax; Allergen-specific immunotherapy; Subcutaneous immunotherapy; SCIT; Mugwort pollen allergy; Artemisia vulgaris; Art v 1; Recombinant allergen; Montanide ISA-51; Ultra-short immunotherapy; Combined Symptom and Medication Score; Allergic rhinitis treatment; Phase II clinical trial; Kazakhstan

Outcome Measures

Primary Outcomes (2)

• Combined Symptom and Medication Score (CSMS) during Peak Pollen Period

  Absolute difference in mean CSMS between each active treatment group and placebo during the Peak Mugwort Pollen Period (PGPP). CSMS is the sum of the daily Symptom Score (dSS) and daily Medication Score (dMS), each ranging from 0 to 3, yielding a total range of 0-6. dSS covers 4 nasal symptoms (nasal itch, sneezing, rhinorrhea, nasal congestion) and 2 ocular symptoms (eye itch, lacrimation), each scored 0-3 and averaged. dMS scores rescue medication use: 0 = none; 1 = oral/ocular/nasal antihistamine; 2 = intranasal corticosteroid ± antihistamine; 3 = oral corticosteroid ± other. PGPP is defined as 15±5 consecutive days with highest mugwort pollen concentrations exceeding 250 grains/m³, determined post-hoc from aerobiological monitoring data. Minimum clinically important difference (MCID): 0.33 CSMS units.

  Up to 20 days during the Peak Mugwort Pollen Period (approximately Week 18-22 after randomization)

• Incidence and Severity of Adverse Events

  Frequency, severity, seriousness, and relationship to study drug of all adverse events (AEs) and serious adverse events (SAEs), classified per MedDRA. Includes local injection site reactions (redness, swelling, induration, pruritus) and systemic reactions assessed within 7 days after each injection. Safety parameters include: vital signs (blood pressure, heart rate, respiratory rate, body temperature); physical examination findings; laboratory tests (CBC, urinalysis, blood biochemistry including ALT, AST, total bilirubin, creatinine, glucose); ECG. Assessed at each study visit from Day 1 through end-of-study follow-up.

  From first injection (Day 1) through end-of-study follow-up visit, approximately 26 weeks after randomization

Secondary Outcomes (9)

• CSMS during General Pollen Season (GPS)

  During the General Pollen Season, approximately Week 9 through Week 26 after randomization

• Daily Symptom Score (dSS) during PGPP and GPS

  Approximately from Week 9 through Week 26 after randomization

• Daily Medication Score (dMS) during PGPP and GPS

  Approximately from Week 9 through Week 26 after randomization

• Rhinoconjunctivitis Discomfort - Visual Analogue Scale (VAS)

  At a minimum of 2 assessments: before onset of PGPP (approximately Week 16 after randomization) and during the Peak Mugwort Pollen Period, approximately at Week 20 after randomization

• Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)

  Baseline (Day 1, pre-season) and follow-up at end of pollen season, approximately 26 weeks after randomization

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants receive four subcutaneous injections of placebo (Montanide ISA-51 oil-in-water emulsion without active substance), administered once weekly at intervals of 7 days (Days 0, 7, 14, 21) in the pre-seasonal period. The placebo is identical to PollenVax in appearance, texture, and volume. Injections are administered into the outer surface of the upper arm, alternating sides. Participants are observed for 2 hours post-injection at the clinical site.

Biological: Montanide ISA-51 placebo emulsion

PollenVax Low Dose

EXPERIMENTAL

Participants receive four subcutaneous injections of PollenVax (recombinant Art v 1 + Montanide ISA-51 adjuvant) at escalating doses: 2 µg → 4 µg → 8 µg → 8 µg rArt v 1, administered once weekly (Days 0, 7, 14, 21) in the pre-seasonal period. Cumulative dose: 22 µg rArt v 1. Injections are administered into the outer surface of the upper arm, alternating sides. Participants are observed for 2 hours post-injection at the clinical site.

Biological: Recombinant Artemisia vulgaris allergen Art v 1 with Montanide ISA-51 adjuvant

PollenVax High Dose

EXPERIMENTAL

Participants receive four subcutaneous injections of PollenVax (recombinant Art v 1 + Montanide ISA-51 adjuvant) at escalating doses: 4 µg → 8 µg → 16 µg → 16 µg rArt v 1, administered once weekly (Days 0, 7, 14, 21) in the pre-seasonal period. Cumulative dose: 44 µg rArt v 1. Injections are administered into the outer surface of the upper arm, alternating sides. Participants are observed for 2 hours post-injection at the clinical site.

Biological: Recombinant Artemisia vulgaris allergen Art v 1 with Montanide ISA-51 adjuvant

Interventions

Recombinant Artemisia vulgaris allergen Art v 1 with Montanide ISA-51 adjuvant BIOLOGICAL

PollenVax is a subcutaneous allergen-specific immunotherapy (SCIT) emulsion consisting of recombinant major mugwort pollen allergen Art v 1 combined with oil-in-water adjuvant Montanide ISA-51 (Seppic, France). Montanide ISA-51 forms a depot at the injection site enabling sustained antigen release and prolonged immune stimulation. Administered as four weekly subcutaneous injections in an ultra-short pre-seasonal regimen. Two dose levels: cumulative 22 µg rArt v 1 (doses: 2-4-8-8 µg) assigned to Arm 2, and cumulative 44 µg rArt v 1 (doses: 4-8-16-16 µg) assigned to Arm 3. Sponsor: Kazakh National Agrarian Research University (KazNARU), Kazakhstan.

Also known as: PollenVax, POL-II-2026 active treatment

PollenVax High Dose; PollenVax Low Dose

Montanide ISA-51 placebo emulsion BIOLOGICAL

Placebo emulsion composed of Montanide ISA-51 (Seppic, France) without the active recombinant allergen Art v 1. Formulated to be identical to PollenVax in appearance, color, texture, and injection volume, ensuring maintenance of double-blind conditions. Administered as four weekly subcutaneous injections following the same schedule as the active treatment arms (Days 0, 7, 14, 21) in the pre-seasonal period. Assigned to Arm 1 (Placebo Comparator).

Also known as: Placebo, ISA-51 emulsion without active substance

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated written informed consent prior to any study-related procedures.
• Age 18 to 65 years (inclusive) at the time of signing informed consent.
• Ability and willingness to comply with all protocol requirements, including attendance at all scheduled visits, completion of study procedures, and maintenance of a patient diary.
• Clinically significant symptoms of allergic rhinitis during the mugwort pollen season, for which allergen-specific immunotherapy (ASIT) is indicated in the investigator's judgment.
• Diagnosis of allergic rhinitis as the primary condition caused by sensitization to mugwort pollen (Artemisia vulgaris), of moderate or severe intensity, with a duration of at least 2 years, per ARIA guidelines. Comorbid mild-to-moderate well-controlled bronchial asthma (per current GINA guidelines) is permitted (ICD-10: J30.1 and/or J45.0).
• Confirmed sensitization to Artemisia vulgaris pollen and/or its major component Art v 1, established by at least one of the following:
• Positive skin prick test (SPT) with wheal diameter ≥3 mm compared to negative control, with adequate positive control; co-sensitization to other inhalant allergens (including ragweed) is permitted provided the mugwort reaction is the largest wheal in the tested panel and corresponds to the seasonal pattern of symptoms; AND/OR
• Specific IgE to the above allergens by ImmunoCAP: positive result (≥Class 1), i.e., above the positivity threshold per manufacturer instructions.
• Physical examination findings (including body temperature, blood pressure, heart rate), laboratory and instrumental parameters without clinically significant abnormalities per investigator assessment.
• Negative urine pregnancy test at screening (for women of childbearing potential).
• Agreement to use adequate contraception from screening until 90 days after completion of study participation (for women of childbearing potential and their partners).

You may not qualify if:

• Prior allergen-specific immunotherapy (ASIT) to Artemisia vulgaris pollen or any other allergen within the last 3 years.
• Sensitization and clinically significant symptoms caused by another inhalant allergen that, per medical history and investigator's clinical assessment, dominate over mugwort-related symptoms and may substantially confound efficacy assessment during the observation period.
• Severe or uncontrolled bronchial asthma, including any of the following:
• Forced expiratory volume in 1 second (FEV1) \< 70% of predicted value at screening;
• Clinically significant asthma symptoms despite baseline therapy;
• Asthma exacerbation requiring systemic corticosteroids, hospitalization, or emergency care within the last 6 months.
• History of life-threatening allergic reactions (including anaphylaxis, airway edema, bronchospasm, Stevens-Johnson syndrome, Lyell syndrome) or any allergic reaction to allergen-specific immunotherapy.
• Chronic or acute ENT disorders at screening that may substantially affect symptom assessment or safety of study participation, including active bacterial rhinosinusitis, severe polypous rhinosinusitis, or significant anatomical nasal obstruction requiring surgical treatment.
• Immunoglobulin therapy within 6 months prior to screening or planned during the study period.
• Treatment with biological agents targeting the immune system (including anti-IgE antibodies such as omalizumab, other monoclonal antibodies, or immune checkpoint inhibitors) within the last 12 months prior to screening or planned during the study.
• Immune system disorders, including autoimmune diseases and primary or secondary immunodeficiencies, except well-controlled autoimmune thyroiditis and uncomplicated type 1 diabetes mellitus.
• Severe acute or chronic inflammatory or infectious diseases in the active phase at screening.
• Severe, decompensated, or unstable comorbid conditions, including but not limited to:
• Severe chronic respiratory failure;
• Liver cirrhosis Child-Pugh class B or C;

Sponsors & Collaborators

• Kazakh National Agrarian University: lead

Study Sites (1)

Limited Liability Partnership "Medcenter-Rakhat"

Almaty, Almaty, 050010, Kazakhstan

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Tair Nurpeissov, MD, PhD

  Limited Liability Partnership "Medcenter-Rakhat"

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaissar Tabynov, PhD

CONTACT

+77016096869; kaissar.tabynov@kaznaru.edu.kz

Tair Nurpeissov, MD, PhD

CONTACT

doctortair@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding is maintained through use of placebo identical in appearance to PollenVax (same emulsion without active substance). Study drug preparation and labeling are performed by a party independent of the clinical site. Unblinding is permitted only in medical emergencies; the procedure for emergency unblinding is described in Protocol Section 4.9.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three parallel groups receiving different interventions simultaneously: placebo, PollenVax low dose (cumulative 22 µg rArt v 1), and PollenVax high dose (cumulative 44 µg rArt v 1). All participants receive four weekly subcutaneous injections in the pre-seasonal period, followed by efficacy assessment during the peak mugwort pollen season (PGPP) and general pollen season (GPS).

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: May 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)