A Randomized, Double-Blind, Placebo-Controlled, Phase II Clinical Trial to Evaluate the Efficacy and Safety of PollenVax, Emulsion for Subcutaneous Injection, in Patients With Allergic Rhinitis Induced by Mugwort (Artemisia Vulgaris) Pollen
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).
• 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).
⁃ Participants who received placebo in the Phase I PollenVax study may be enrolled if they meet all inclusion criteria of this study and had no serious adverse events related to Phase I participation.