Phase I Study of PollenVax in Patients With Mugwort Pollen-Induced Allergic Rhinitis (NCT07317960) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Phase I Study of PollenVax in Patients With Mugwort Pollen-Induced Allergic Rhinitis
Kazakhstan30 participantsStarted 2025-11-22
Plain-language summary
This Phase I randomized, double-blind, placebo-controlled clinical trial evaluates the safety and tolerability of PollenVax, a novel recombinant allergen-based vaccine for allergen-specific immunotherapy, in adult patients with mugwort pollen-induced allergic rhinitis.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Provision of written informed consent, dated and signed by the participant and the investigator prior to any study-related procedures;
✓. Male or female participants;
✓. Age 18 to 65 years, inclusive;
✓. Ability and willingness to comply with all study procedures and attend all scheduled study visits for medical follow-up;
✓. Patients with allergic rhinitis as the primary diagnosis, of moderate to severe severity, caused by mugwort pollen (Artemisia vulgaris) for at least two years, in accordance with the recommendations of Allergic Rhinitis and its Impact on Asthma (ARIA); patients may have well-controlled asthma as a comorbid condition, of mild to moderate severity, according to the Global Initiative for Asthma (GINA 2022-2024) guidelines, or no asthma;
✓. A positive skin prick test to Artemisia vulgaris with a wheal diameter of ≥ 3 mm, confirmed using appropriate positive and negative controls;
✓. Presence of specific immunoglobulin E (IgE) to Artemisia vulgaris major allergen Art v 1 at Class ≥ 2, determined using ImmunoCAP technology;
✓. Sensitization to Artemisia vulgaris associated with clinically significant allergic symptoms for which allergen-specific immunotherapy (ASIT) is indicated;
Exclusion criteria
✕. Previous allergen-specific immunotherapy (ASIT) to Artemisia vulgaris or any other cross-reactive allergen within the past 5 years, or current ASIT to any allergen;
✕
What they're measuring
1
Safety and tolerability of PollenVax after four subcutaneous administrations
Timeframe: From first administration through 50 days after the last injection
2
Frequency and pattern of adverse events following administration of PollenVax
Timeframe: From first administration through 50 days after the last injection
. Concomitant sensitization that may interfere with study conduct or interpretation, particularly if the skin prick test response to another allergen exceeds that to Artemisia vulgaris;
✕. Severe asthma or forced expiratory volume in 1 second (FEV₁) ≤ 80% predicted, even if pharmacologically controlled;
✕. History of severe systemic reactions to allergen-specific immunotherapy;
✕. Complications of allergic rhinitis at screening, including allergic sinusitis, nasal polyps, tonsillitis, or otitis media;
✕. Treatment with immunoglobulin therapy;
✕. Completed or ongoing treatment with anti-IgE monoclonal antibodies (e.g., omalizumab) and/or immune checkpoint inhibitors;
✕. Immune system disorders, including autoimmune diseases or immunodeficiency states, except for well-controlled Hashimoto's thyroiditis or type 1 diabetes mellitus;