RecruitingPhase 2NCT07563439

PollenVax Subcutaneous Immunotherapy for Mugwort Pollen-Induced Allergic Rhinitis

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

Sponsor

Kazakh National Agrarian University

Enrollment

138 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

Rhinitis, Allergic

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).

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Montanide ISA-51 placebo emulsion and a biological treatment called Recombinant Artemisia vulgaris allergen Art v 1 with Montanide ISA-51 adjuvant for people with rhinitis, allergic. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALRecombinant 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.

BIOLOGICALMontanide ISA-51 placebo emulsion

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).