Phase I Study of PollenVax in Patients With Mugwort Pollen-Induced Allergic Rhinitis (NCT07317960) | Clinical Trial Compass
CompletedPhase 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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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;
. 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;