PollenVax Subcutaneous Immunotherapy for Mugwort Pollen-Induced Allergic Rhinitis
ConditionRhinitis Allergic
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKazakh National Agrarian University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Forced expiratory volume in 1 second (FEV1) < 70% of predicted value at screening;
Clinically significant asthma symptoms despite baseline therapy;
Trial design
Design model
Parallel
Treatments tested in this trial
Recombinant Artemisia vulgaris allergen Art v 1 with Montanide ISA-51 adjuvant
Biological/VaccinePollenVax 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.
Montanide ISA-51 placebo emulsion
Biological/VaccinePlacebo 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).
Treatment groups
138 Participants
are divided into 3 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: PollenVax Low DoseExperimental treatment 1 intervention
Group C: PollenVax High DoseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 20 days during the Peak Mugwort Pollen Period (approximately Week 18-22 after randomization)2
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.
Time frame
From first injection (Day 1) through end-of-study follow-up visit, approximately 26 weeks after randomizationSecondary outcomes
1
CSMS during General Pollen Season (GPS)
Absolute and relative difference in mean CSMS between each active treatment group and placebo during the full General Pollen Season (GPS), defined as the period during which mugwort pollen concentrations consistently exceed 51 grains/m³. Assessed using the same EAACI methodology as the primary endpoint.
Time frame
During the General Pollen Season, approximately Week 9 through Week 26 after randomization2
Daily Symptom Score (dSS) during PGPP and GPS
Absolute and relative difference in mean daily Symptom Score (dSS) between each active treatment group and placebo during PGPP and GPS. dSS is the average of 6 individual symptom scores (4 nasal + 2 ocular), each rated 0-3 by the participant in a daily diary, yielding a range of 0-3.
Time frame
Approximately from Week 9 through Week 26 after randomization3
Daily Medication Score (dMS) during PGPP and GPS
Absolute and relative difference in mean daily Medication Score (dMS) between each active treatment group and placebo during PGPP and GPS. dMS reflects the highest level of rescue medication used on a given day, scored 0-3 per EAACI methodology.
Time frame
Approximately from Week 9 through Week 26 after randomization4
Rhinoconjunctivitis Discomfort - Visual Analogue Scale (VAS)
Change in overall rhinoconjunctivitis discomfort assessed by a 10-cm horizontal VAS (range 0-100 mm; 0 = no symptoms, fully comfortable; 100 = maximum possible symptoms, severe discomfort). Participants mark their current-day level of rhinoconjunctivitis discomfort. The score is measured in millimeters from the left edge to the participant's mark. Minimum Clinically Important Difference (MCID): reduction of ≥23 mm compared to previous assessment (per EAACI/ARIA guidelines). Assessed at least twice: before onset of peak pollen period and during the peak season, at 2-week intervals.
Time frame
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 randomizationSponsors and contacts
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Source ClinicalTrials.gov