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PollenVax Subcutaneous Immunotherapy for Mugwort Pollen-Induced Allergic Rhinitis

NCT07563439 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2026-06-29

No results posted yet for this study

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).

Conditions

  • Rhinitis Allergic

Interventions

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.

BIOLOGICAL

Montanide 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).

Sponsors & Collaborators

  • Kazakh National Agrarian University

    lead OTHER

Principal Investigators

  • Tair Nurpeissov, MD, PhD · Limited Liability Partnership "Medcenter-Rakhat"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-09-30
Completion
2026-11-30

Countries

  • Kazakhstan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07563439 on ClinicalTrials.gov