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New treatment option for Rhinitis Allergic
Official title PollenVax Subcutaneous Immunotherapy for Mugwort Pollen-Induced Allergic Rhinitis
ClinicalTrials.gov ID: NCT07563439
What this study is testing
What is Recombinant Artemisia vulgaris allergen Art v 1 with Montanide ISA-51 adjuvant?
Recombinant Artemisia vulgaris allergen Art v 1 with Montanide ISA-51 adjuvant is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for rhinitis allergic.
Also referred to as PollenVax, POL-II-2026 active treatment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- Clinically significant symptoms of allergic rhinitis during the mugwort pollen season, for which allergen-specific immunotherapy (ASIT) is indicated...
- Diagnosis of allergic rhinitis as the primary condition caused by sensitization to mugwort pollen (Artemisia vulgaris), of moderate or severe...
You likely can't join if
- Prior allergen-specific immunotherapy (ASIT) to Artemisia vulgaris pollen or any other allergen within the last 3 years.
- Sensitization and clinically significant symptoms caused by another inhalant allergen that, per medical history and investigator's clinical...
- Severe or uncontrolled bronchial asthma, including any of the following:
- Forced expiratory volume in 1 second (FEV1) \< 70% of predicted value at screening;
- Clinically significant asthma symptoms despite baseline therapy;
- Asthma exacerbation requiring systemic corticosteroids, hospitalization, or emergency care within the last 6 months.
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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 of this study and had no serious adverse events related to Phase I participation.
What rules you out
- Prior allergen-specific immunotherapy (ASIT) to Artemisia vulgaris pollen or any other allergen within the last 3 years.
- Sensitization and clinically significant symptoms caused by another inhalant allergen that, per medical history and investigator's clinical assessment, dominate over mugwort-related symptoms and may substantially...
- Severe or uncontrolled bronchial asthma, including any of the following:
- Forced expiratory volume in 1 second (FEV1) \< 70% of predicted value at screening;
- Clinically significant asthma symptoms despite baseline therapy;
- Asthma exacerbation requiring systemic corticosteroids, hospitalization, or emergency care within the last 6 months.
- History of life-threatening allergic reactions (including anaphylaxis, airway edema, bronchospasm, Stevens-Johnson syndrome, Lyell syndrome) or any allergic reaction to allergen-specific immunotherapy.
- Chronic or acute ENT disorders at screening that may substantially affect symptom assessment or safety of study participation, including active bacterial rhinosinusitis, severe polypous rhinosinusitis, or significant...
- Immunoglobulin therapy within 6 months prior to screening or planned during the study period.
- Treatment with biological agents targeting the immune system (including anti-IgE antibodies such as omalizumab, other monoclonal antibodies, or immune checkpoint inhibitors) within the last 12 months prior to screening...
- Immune system disorders, including autoimmune diseases and primary or secondary immunodeficiencies, except well-controlled autoimmune thyroiditis and uncomplicated type 1 diabetes mellitus.
- Severe acute or chronic inflammatory or infectious diseases in the active phase at screening.
- Severe, decompensated, or unstable comorbid conditions, including but not limited to:
- Severe chronic respiratory failure;
- Liver cirrhosis Child-Pugh class B or C;
- Unstable angina or clinically significant ischemic heart disease;
- Chronic heart failure NYHA class III-IV or decompensated stage;
- Uncontrolled arterial hypertension (systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg) despite treatment;
- Clinically significant cardiac arrhythmias, including high-grade ventricular arrhythmias (Lown classification);
- Myocardial infarction, acute stroke, transient ischemic attack, or pulmonary embolism within 6 months prior to Visit 0, or aortic aneurysm \>6 cm;
- Less than 3 months after coronary artery bypass grafting or coronary stenting;
- Any other condition that, in the investigator's judgment, may affect patient safety or interpretation of study results;
- Active malignancy of any location or malignancy within the last 5 years, except fully treated carcinoma in situ;
- Severe renal failure;
- Severe hepatic failure.
- Serologically confirmed infection with HIV, hepatitis B, or hepatitis C virus.
- Exacerbation of chronic allergic skin disease (including atopic dermatitis or generalized urticaria) at screening that may confound assessment of allergic symptoms.
- Clinically significant abnormalities in routine laboratory tests per investigator assessment.
- Alcohol, drug, or substance dependence within the past year per investigator assessment.
- Pregnancy or breastfeeding.
- Inability to discontinue beta-blocker therapy (systemic or topical) and/or presence of a condition where epinephrine use for anaphylaxis management is substantially limited per investigator's clinical assessment.
- Use of immunosuppressive agents or other medications that cannot be discontinued during the study period and may affect patient safety or how well it works assessment.
- Severe psychiatric or neurological disorders impairing the ability to provide informed consent or comply with protocol requirements.
- Legal incapacity or limited legal capacity.
- Factors indicating high risk of non-compliance with study procedures, including inability to attend regular visits, maintain a patient diary, or follow protocol requirements per investigator assessment.
The study team makes the final eligibility decision.
Where it's taking place
- Almaty, Almaty, Kazakhstan
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Almaty, Almaty, Kazakhstan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.