PollenVax Subcutaneous Immunotherapy for Mugwort Pollen-Induced Allergic Rhinitis
Kazakhstan138 participantsStarted 2026-05-01
Plain-language 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).
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Combined Symptom and Medication Score (CSMS) during Peak Pollen Period
Timeframe: Up to 20 days during the Peak Mugwort Pollen Period (approximately Week 18-22 after randomization)
2
Incidence and Severity of Adverse Events
Timeframe: From first injection (Day 1) through end-of-study follow-up visit, approximately 26 weeks after randomization
. Confirmed sensitization to Artemisia vulgaris pollen and/or its major component Art v 1, established by at least one of the following:
. 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).
Exclusion criteria
. 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:
. 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.