A Phase 2 interventional study of Recombinant Artemisia vulgaris allergen Art v 1 with Montanide ISA-51 adjuvant and Montanide ISA-51 placebo emulsion in Rhinitis Allergic, sponsored by Kazakh National Agrarian University. Recruiting at 1 site in Kazakhstan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Kazakh National Agrarian University · Phase 2, Interventional, and Treatment
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).
Background and Rationale IgE-mediated allergic diseases affect approximately 35% of the population in industrialized countries, with prevalence continuing to rise. Mugwort (Artemisia vulgaris) pollen is among the top ten global aeroallergens responsible for seasonal allergic rhinitis and allergic asthma. In Kazakhstan, mugwort pollen is the causative allergen in 68% of children and adolescents diagnosed with allergic rhinitis and asthma. Allergen-specific immunotherapy (ASIT) remains the only disease-modifying treatment for IgE-mediated allergy, capable of inducing long-term tolerance by shifting immune responses from Th2 toward Th1 and regulatory T-cell (Treg) profiles. Conventional subcutaneous ASIT (SCIT) requires 3-5 years of treatment with frequent injections, leading to low patient compliance. There is a clear unmet need for shorter, effective SCIT regimens.
Investigational Product PollenVax is an original subcutaneous allergen immunotherapy product developed by Kazakh National Agrarian Research University (KazNARU). It consists of recombinant major mugwort pollen allergen Art v 1 combined with the oil-in-water adjuvant Montanide ISA-51 (Seppic, France). The Montanide ISA-51 adjuvant forms a depot at the injection site, enabling sustained antigen release and prolonged immune stimulation. PollenVax is the first recombinant Art v 1 product formulated with Montanide ISA-51 for subcutaneous ASIT of mugwort pollen-induced allergic disease. It is designed for an ultra-short treatment course of four weekly subcutaneous injections, with the aim of improving patient compliance and reducing the number of required clinic visits compared to conventional SCIT regimens.
Preclinical Evidence Preclinical studies in mouse and guinea pig models of mugwort pollen sensitization demonstrated that PollenVax (recombinant Art v 1 + Montanide ISA-51) produced a superior immunological profile compared to other tested formulations. Key findings included: significant reduction of total and allergen-specific IgE; marked increase in protective IgG antibodies; shift from Th2-dominant to Th1-dominant immune response; and reduction of lung eosinophilic inflammation superior to sublingual immunotherapy (SLIT)-based approaches. Efficacy was demonstrated in both pre-seasonal and co-seasonal (during active pollen exposure) administration paradigms. Safety studies in guinea pigs, mice, and rats showed no anaphylactic reactions and no delayed-type hypersensitivity responses. Acute and subchronic toxicity studies in rats classified PollenVax in Hodge-Sterner Class 5 (practically non-toxic), with the No Observed Adverse Effect Level (NOAEL) established at the maximum tested dose of 0.4 mL per injection.
Phase I Clinical Evidence A completed Phase I randomized, double-blind, placebo-controlled study enrolled 30 adults with confirmed mugwort pollen-induced allergic rhinitis. Participants received PollenVax in the ultra-short SCIT regimen of four weekly subcutaneous injections at cumulative doses of 22 µg or 44 µg recombinant Art v 1, or placebo. Primary Phase I objectives were safety and tolerability.
Safety outcomes: No deaths, serious adverse events (SAEs), anaphylaxis, or high-grade systemic allergic reactions were observed. Adverse events were predominantly mild-to-moderate local injection site reactions (redness, induration, pruritus) that were transient and self-resolving without specific treatment.
Immunological outcomes: Phase I demonstrated marked induction of Art v 1-specific IgG4, minimal IgE induction, statistically significant reduction in skin prick test reactivity, and dose-dependent Th1/regulatory T-cell immune modulation - consistent with the expected mechanism of action of effective ASIT.
These Phase I results supported the safety profile and immunological activity of PollenVax and provided the basis for proceeding to this Phase II efficacy and safety study.
Statistical Approach The primary efficacy analysis will use Analysis of Covariance (ANCOVA) with the Combined Symptom and Medication Score (CSMS) as the dependent variable, treatment group as the fixed factor, and baseline sensitization measures (Art v 1-specific IgE, SPT wheal area, ALEX² molecular allergy test result) as covariates, applied to the Intent-to-Treat/Full Analysis Set (ITT/FAS) population. A linear mixed model (LMM) will additionally adjust for potential co-sensitization to Chenopodiaceae and Ambrosia pollen as confounders. The significance level is α = 0.05 (two-sided). The sample size of 46 participants per group (138 total) provides 80% power to detect a Minimum Clinically Important Difference (MCID) of 0.33 CSMS units (assumed SD = 0.7), with a 10% dropout allowance incorporated.
178 studies on the registry are indexed under Rhinitis, Allergic, Perennial; 9 are open to participants now.
This study's planned enrollment of 138 is close to the median of 135 across 157 interventional studies indexed under Rhinitis, Allergic, Perennial.
Browse Rhinitis, Allergic, Perennial studies →Kazakh National Agrarian University is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Confirmed sensitization to Artemisia vulgaris pollen and/or its major component Art v 1, established by at least one of the following:
Exclusion Criteria:
Severe or uncontrolled bronchial asthma, including any of the following:
Severe, decompensated, or unstable comorbid conditions, including but not limited to:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
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)
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 randomization
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 randomization
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 randomization
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 randomization
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 randomization
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Change from pre-season baseline in RQLQ total and domain scores between each active treatment group and placebo. RQLQ is a validated 28-item instrument covering 7 domains (activities, sleep, non-nasal/eye symptoms, practical problems, nasal symptoms, eye symptoms, emotional function), scored 0-6 per item. Total score is expressed as the mean of all 28 items, ranging from 0 to 6, where higher scores indicate worse rhinoconjunctivitis-related quality of life. Minimum Clinically Important Difference (MCID): 0.5 points.
Time frame: Baseline (Day 1, pre-season) and follow-up at end of pollen season, approximately 26 weeks after randomization
Asthma Quality of Life Questionnaire (AQLQ) in Participants with Comorbid Asthma
AQLQ scores in participants with comorbid mild-to-moderate well-controlled asthma (ICD-10: J45.0), comparing active treatment groups to placebo. Instrument includes 15 items across 4 domains (asthma symptoms, activity limitations, emotional consequences, environmental stimuli), scored 1-7 per item (1 = not troubled; 7 = extremely troubled). Mean total and domain scores calculated. Analysis by ANCOVA. MCID: reduction of ≥0.5 points in mean score (per international recommendations).
Time frame: Single assessment during the Peak Mugwort Pollen Period (up to 20 days), approximately at Weeks 18-22 after randomization; in participants with comorbid asthma only
Proportion of Well-Controlled, Symptomatic, and Symptom-Free Days
Three categories assessed during PGPP and GPS: (1) Well-controlled day: dMS = 0 AND dSS \< 0.34; (2) Symptom-free day: dSS = 0 AND dMS = 0; (3) Severe day: any of 6 individual symptoms (nasal itch, sneezing, rhinorrhea, nasal congestion, eye itch, lacrimation) scored at maximum = 3. For each participant, percentage of days in each category = (number of qualifying days ÷ total days in PGPP or GPS) × 100%. Comparison between active and placebo groups using parametric or non-parametric methods depending on data distribution.
Time frame: During the Peak Mugwort Pollen Period (up to 20 days) and the General Pollen Season, approximately from Week 9 through Week 26 after randomization, based on daily patient diary
Skin Prick Test (SPT) Reactivity to Artemisia vulgaris and Art v 1
Change in SPT wheal area (mm²) calculated as ellipse area: S = (π × D\_max × D\_perp) / 4, corrected for background reaction (wheal of 3 mm negative control, S\_background ≈ 7.07 mm²). Percentage reduction in skin sensitivity: \[(S\_pre - S\_background) - (S\_post - S\_background)\] / (S\_pre - S\_background) × 100%. Assessed with Artemisia vulgaris pollen extract and recombinant Art v 1. Analysis by mean percentage reduction per group; comparison between active and placebo groups by t-test/ANCOVA or non-parametric methods.
Time frame: 3 timepoints: Baseline (Day 1), Week 5 (Day 36±3, approximately 2 weeks after completion of the immunotherapy course), and end-of-season follow-up at approximately Week 26 after randomization
Art v 1-Specific Immunoglobulin Levels (IgE, IgG1-4) and Allergen-Blocking Antibodies
Serum levels of Art v 1-specific IgE (kU/L), IgG4 (mg/L) and total IgE (kU/L) measured by fluorescence enzyme immunoassay on Phadia™ 250 analyzer (ThermoFisher Scientific). Serum levels of Art v 1-specific IgG subclasses (IgG1, IgG2, IgG3, IgG4) measured by in-house indirect ELISA, expressed as optical density (OD) at 450 nm or endpoint antibody titers. Capacity of serum antibodies to inhibit IgE-Art v 1 allergen binding, assessed by inhibition ELISA and expressed as percent inhibition (%). Changes from baseline assessed at each timepoint; comparison between active and placebo groups. Key marker of immune shift toward protective IgG response and IgE-blocking activity.
Time frame: 3 timepoints: Baseline (Day 1), Week 5 (Day 36±3, approximately 2 weeks after completion of the immunotherapy course), and end-of-season follow-up at approximately Week 26 after randomization
Plan to share: No — Individual participant data will not be shared publicly due to confidentiality obligations under the study protocol and applicable data protection regulations of the Republic of Kazakhstan. Aggregated summary data will be available upon publication of study results.
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Kazakh National Agrarian University