Rhinitis AllergicPhase 1NCT07317960
Phase I Study of PollenVax in Patients With Mugwort Pollen-Induced Allergic Rhinitis
A Phase 1 study testing PollenVax in people with Rhinitis Allergic, run by Kazakh National Agrarian University at 1 site in Kazakhstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinitis Allergic
- What is being tested?
- PollenVax
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteKazakhstan
- Study dates
- 22 Nov 2025to 16 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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;
- Laboratory and instrumental test results within normal ranges or showing deviations not considered clinically significant by the investigator;
- Body mass index (BMI) between 18.5 and 30.0 kg/m², inclusive;
- Normal body temperature, defined as 35.5 °C to 36.6 °C, inclusive;
- Resting blood pressure within the following ranges:
- Systolic blood pressure (SBP): 120-129 mmHg
- Diastolic blood pressure (DBP): 60-89 mmHg
- For women of childbearing potential, a negative pregnancy test at screening;
- Agreement to use adequate contraception methods from screening until 90 days after completion of the study.
Who cannot join
- 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;
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- 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;
- Severe acute or chronic inflammatory or infectious diseases;
- Decompensated comorbid conditions, including severe, unstable, or uncontrolled somatic diseases based on medical history, such as:
- Severe respiratory failure;
- Liver cirrhosis Child-Pugh class B or C;
- Severe or unstable angina pectoris;
- Chronic heart failure NYHA class III-IV or decompensated heart failure;
- Uncontrolled arterial hypertension (systolic blood pressure >130 mmHg and/or diastolic blood pressure >90 mmHg);
- Uncontrolled cardiac arrhythmias, including Lown class IVb or V ventricular arrhythmias or bifascicular intraventricular block;
- Myocardial infarction, acute cerebrovascular accident, transient ischemic attack, or pulmonary embolism within 6 months prior to study entry (Visit 0), or large aortic aneurysm (>6 cm);
- Coronary artery bypass grafting or coronary stenting within 3 months prior to study entry (Visit 0);
- Any other condition that, in the opinion of the investigator, may interfere with interpretation of study results or limit the participant's ability to complete the study;
- Malignancy of any localization currently or within 5 years prior to enrollment, except for completely treated carcinoma in situ;
- History of severe renal insufficiency;
- History of severe hepatic insufficiency;
- Human immunodeficiency virus (HIV) infection, syphilis, hepatitis B virus, and/or hepatitis C virus infection;
- Exacerbation of chronic allergic skin diseases (e.g., atopic dermatitis, generalized urticaria) as determined by physical examination;
- Substance abuse, including alcohol, narcotics, or prescription drug abuse, within the past year and/or during the study;
- For women of reproductive potential: pregnancy and/or lactation;
- For women: unprotected sexual intercourse with a non-sterilized male partner within 30 days prior to screening;
- Systemic or local (including ophthalmic) beta-blocker therapy;
- Use of prohibited medications, including but not limited to:
- Systemic leukotriene receptor antagonists (e.g., montelukast);
- Systemic ketotifen;
- Beta-blockers (systemic or topical);
- Medications containing terfenadine, theophylline or its derivatives;
- Roflumilast or other phosphodiesterase-4 (PDE-4) inhibitors;
- Pseudoephedrine, tiotropium, or other anticholinergic agents;
- Cromones or mast cell stabilizers;
- Phenothiazines;
- Immunosuppressive therapy;
- Antiviral or antibacterial vaccination within 14 days before and 7 days after administration of the investigational product;
- Contraindications to epinephrine administration, including but not limited to symptomatic ischemic heart disease, severe hypertension, hyperthyroidism, or glaucoma;
- Severe psychiatric or neurological disorders, or completed or ongoing long-term treatment with tranquilizers or psychoactive medications, including tricyclic antidepressants;
- Legally incapacitated individuals;
- Participants considered to be at high risk of non-compliance with study procedures.
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site
Limited Liability Partnership "Medcenter-Rakhat"
Almaty, Almaty, 050000
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety and Tolerability of PollenVax, a Subcutaneous Emulsion, in Patients With Mugwort Pollen-Induced Allergic Rhinitis
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.
Read the detailed description
This single-center Phase I randomized, double-blind, placebo-controlled study is designed to assess the safety, tolerability, and immunogenicity of PollenVax, a recombinant allergen-based vaccine containing Artemisia pollen major allergen Art v 1 formulated with Montanide ISA 51 adjuvant.
The study evaluates an ultra-short subcutaneous allergen-specific immunotherapy regimen consisting of four weekly injections administered during the remission period outside the active pollen season.
- Conditions
- Rhinitis Allergic
- Being tested
- PollenVax, Placebo
- Keywords
- Mugwort Pollen Allergy, Artemisia Allergy, Allergen-Specific Immunotherapy, recombinant Artemisia pollen major allergen Art v 1, an ultra-short subcutaneous allergen-specific immunotherapy regimen
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PollenVaxBiological
PollenVax is a recombinant allergen-based vaccine containing recombinant Artemisia pollen major allergen Art v 1 formulated with Montanide ISA 51 adjuvant. The vaccine is administered subcutaneously in an ultra-short allergen-specific immunotherapy regimen consisting of four injections.
PlaceboOther
The placebo is a matching emulsion for subcutaneous administration without the active recombinant allergen, administered according to the same schedule as the investigational product.
| Study group | Role | What they receive |
|---|---|---|
| PollenVax | Experimental | Participants receive PollenVax, a recombinant allergen-based vaccine containing recombinant Artemisia pollen major allergen Art v 1 formulated with Montanide ISA 51 adjuvant, administered subcutaneously in an ultra-short immunotherapy regimen. Receives: Biological: PollenVax |
| Placebo Comparator | Placebo comparator | Participants receive a matching placebo emulsion for subcutaneous administration according to the same schedule as the investigational product. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of PollenVax after four subcutaneous administrations
Evaluation of the safety and tolerability of PollenVax based on the incidence, severity, and relationship to study treatment of adverse events (AEs) and serious adverse events (SAEs) following four subcutaneous administrations in patients with mugwort pollen-induced seasonal allergic rhinitis during the remission period outside the active pollen season.
Measured: From first administration through 50 days after the last injection
Frequency and pattern of adverse events following administration of PollenVax
Assessment of the frequency, type, and severity of local and systemic adverse events occurring after four subcutaneous administrations of PollenVax, including identification of the most commonly observed adverse events.
Measured: From first administration through 50 days after the last injection
Secondary outcomes (3)
Dose-related safety profile of PollenVax
Evaluation of the relationship between administered dose levels of PollenVax and the occurrence and severity of adverse events in patients with mugwort pollen-induced seasonal allergic rhinitis.
Measured: From first administration through 50 days after the last injection
Humoral immunogenicity of PollenVax
Assessment of humoral allergen-specific immune response based on changes in serum levels of allergen-specific IgE and IgG4 antibodies to Artemisia pollen major allergen Art v 1 measured before and after allergen-specific immunotherapy.
Measured: Baseline to Day 50
Exploratory assessment of cellular immune response to PollenVax
Exploratory evaluation of cellular immune response based on changes in Th1/Th2 cytokine profiles in peripheral blood mononuclear cell cultures stimulated with recombinant Art v 1 before and after allergen-specific immunotherapy.
Measured: Baseline to Day 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start22 Nov 2025
- Primary completion16 Jan 2026
- Study completion16 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rhinitis AllergicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three parallel groups receiving different interventions simultaneously: placebo, PollenVax low dose (cumulative 22 µg rArt v 1), and PollenVax high dose (cumulative 44 µg rArt v 1). All participants receive four weekly subcutaneous injections in the pre-seasonal period
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kazakh National Agrarian University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tair Nurpeissov, Principal investigator, Limited Liability Partnership "Medcenter-Rakhat"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317960
- Sponsor's protocol ID
- POL-I-30-2025
- Other IDs
- BR25293305
- Status last verified
- Jun 2026
- First submitted
- 19 Dec 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in publications, including demographic characteristics, safety outcomes (adverse events and serious adverse events), and immunogenicity endpoints (allergen-specific IgE and IgG4 measurements). Data will be fully anonymized and will not include any information that could identify individual participants.
Publications
Tabynov K, Tailakova E, Rakhmatullayeva G, Bolatbekov T, Lim YH, Fomin G, Babayeva M, Valenta R, Tabynov K. Comparison of rArt v 1-based sublingual and subcutaneous immunotherapy in a murine model of asthma. NPJ Vaccines. 2025 Apr 2;10(1):66. doi: 10.1038/s41541-025-01112-1.
PubMed 40175385Nurpeissov T, Tabynov K, Zhubanturliyeva A, Nurpeissov T, Khan V, Seidakhmetov O, Yessimova B, Sarsenbayeva G, Tailakova E, Bolatbekov T, Sergazina A, Akhtemova N, Rakhmatullayeva G, Yelchibayeva L, Shorayeva K, Yershebulov Z, Petrovsky N, Tabynov K. Ultra-short recombinant Art v 1 immunotherapy induces rapid immune modulation in mugwort allergy: A Phase I trial. Allergol Int. 2026 Jun 23:S1323-8930(26)00076-6. doi: 10.1016/j.alit.2026.05.010. Online ahead of print.
PubMed 42336691
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety and Tolerability of PollenVax, a Subcutaneous Emulsion, in Patients With Mugwort Pollen-Induced Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT07317960
- Acronym / sponsor ID
- POL-I-30-2025
- Conditions
- Rhinitis Allergic
- Keywords
- Mugwort Pollen Allergy, Artemisia Allergy, Allergen-Specific Immunotherapy, recombinant Artemisia pollen major allergen Art v 1, an ultra-short subcutaneous allergen-specific immunotherapy regimen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kazakh National Agrarian UniversityUniversity, hospital or other
- Study start
- 22 Nov 2025 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- 16 Jan 2026 (actual)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This single-center Phase I randomized, double-blind, placebo-controlled study is designed to assess the safety, tolerability, and immunogenicity of PollenVax, a recombinant allergen-based vaccine containing Artemisia pollen major allergen Art v 1 formulated with Montanide ISA 51 adjuvant.
The study evaluates an ultra-short subcutaneous allergen-specific immunotherapy regimen consisting of four weekly injections administered during the remission period outside the active pollen season.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Three parallel groups receiving different interventions simultaneously: placebo, PollenVax low dose (cumulative 22 µg rArt v 1), and PollenVax high dose (cumulative 44 µg rArt v 1). All participants receive four weekly subcutaneous injections in the pre-seasonal period
| Arm | Type | Receives |
|---|---|---|
| PollenVax | Experimental | Biological: PollenVaxParticipants receive PollenVax, a recombinant allergen-based vaccine containing recombinant Artemisia pollen major allergen Art v 1 formulated with Montanide ISA 51 adjuvant, administered subcutaneously in an ultra-short immunotherapy regimen. |
| Placebo Comparator | Placebo comparator | Other: PlaceboParticipants receive a matching placebo emulsion for subcutaneous administration according to the same schedule as the investigational product. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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;
Key exclusion criteria (43 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PollenVaxPollenVax is a recombinant allergen-based vaccine containing recombinant Artemisia pollen major allergen Art v 1 formulated with Montanide ISA 51 adjuvant. The vaccine is administered subcutaneously in an ultra-short allergen-specific immunotherapy regimen consisting of four injections. | Biological | PollenVax |
| PlaceboThe placebo is a matching emulsion for subcutaneous administration without the active recombinant allergen, administered according to the same schedule as the investigational product. | Other | Placebo Comparator |
Primary outcome
Safety and tolerability of PollenVax after four subcutaneous administrations
Time frame: From first administration through 50 days after the last injection
Evaluation of the safety and tolerability of PollenVax based on the incidence, severity, and relationship to study treatment of adverse events (AEs) and serious adverse events (SAEs) following four subcutaneous administrations in patients with mugwort pollen-induced seasonal allergic rhinitis during the remission period outside the active pollen season.
Frequency and pattern of adverse events following administration of PollenVax
Time frame: From first administration through 50 days after the last injection
Assessment of the frequency, type, and severity of local and systemic adverse events occurring after four subcutaneous administrations of PollenVax, including identification of the most commonly observed adverse events.
3 secondary outcomes
Dose-related safety profile of PollenVax
Time frame: From first administration through 50 days after the last injection
Humoral immunogenicity of PollenVax
Time frame: Baseline to Day 50
Exploratory assessment of cellular immune response to PollenVax
Time frame: Baseline to Day 50
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Results publication: PubMed 40175385Tabynov K, Tailakova E, Rakhmatullayeva G, Bolatbekov T, Lim YH, Fomin G, Babayeva M, Valenta R, Tabynov K. Comparison of rArt v 1-based sublingual and subcutaneous immunotherapy in a murine model of asthma. NPJ Vaccines. 2025 Apr 2;10(1):66. doi: 10.1038/s41541-025-01112-1.
- Derived from this study: PubMed 42336691Nurpeissov T, Tabynov K, Zhubanturliyeva A, Nurpeissov T, Khan V, Seidakhmetov O, Yessimova B, Sarsenbayeva G, Tailakova E, Bolatbekov T, Sergazina A, Akhtemova N, Rakhmatullayeva G, Yelchibayeva L, Shorayeva K, Yershebulov Z, Petrovsky N, Tabynov K. Ultra-short recombinant Art v 1 immunotherapy induces rapid immune modulation in mugwort allergy: A Phase I trial. Allergol Int. 2026 Jun 23:S1323-8930(26)00076-6. doi: 10.1016/j.alit.2026.05.010. Online ahead of print.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in publications, including demographic characteristics, safety outcomes (adverse events and serious adverse events), and immunogenicity endpoints (allergen-specific IgE and IgG4 measurements). Data will be fully anonymized and will not include any information that could identify individual participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tair Nurpeissov principal investigator
Limited Liability Partnership "Medcenter-Rakhat"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PollenVax in people with Rhinitis Allergic, run by Kazakh National Agrarian University at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of PollenVax after four subcutaneous administrations (time frame: From first administration through 50 days after the last injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07317960, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.