Phase I Study of PollenVax in Patients With Mugwort Pollen-Induced Allergic Rhinitis

NCT07317960 | Active Not Recruiting Phase 1

• 2 other identifiers: POL-I-30-2025BR25293305
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Allergic Rhinitis Due to Artemisia Pollen

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From first administration through 50 days after the last injection

Secondary Outcomes (3)

• Dose-related safety profile of PollenVax

  From first administration through 50 days after the last injection

• Humoral immunogenicity of PollenVax

  Baseline to Day 50

• Exploratory assessment of cellular immune response to PollenVax

  Baseline to Day 50

Study Arms (2)

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.

Biological: PollenVax

Placebo Comparator

PLACEBO COMPARATOR

Participants receive a matching placebo emulsion for subcutaneous administration according to the same schedule as the investigational product.

Other: Placebo

Interventions

PollenVax BIOLOGICAL

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.

PollenVax

Placebo OTHER

The placebo is a matching emulsion for subcutaneous administration without the active recombinant allergen, administered according to the same schedule as the investigational product.

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• Kazakh National Agrarian University: lead

Study Sites (1)

Limited Liability Partnership "Medcenter-Rakhat"

Almaty, Almaty, 050000, Kazakhstan

Location

Related Publications (1)

• 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.

  PMID: 40175385 RESULT

Study Officials

• Tair Nurpeissov

  Limited Liability Partnership "Medcenter-Rakhat"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: No additional parties are masked beyond those listed above.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized in parallel to receive either the investigational product (PollenVax) or placebo and remain in their assigned treatment group throughout the study without crossover.

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 5, 2026
• Study Start: November 22, 2025
• Primary Completion: January 14, 2026
• Study Completion: January 19, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The IPD and supporting documents will be available beginning 6 months after publication of the primary study results and will remain available for up to 5 years thereafter.
• Access Criteria: Access to de-identified IPD and supporting documents will be provided to qualified researchers upon reasonable request. Requests must include a research proposal and will be reviewed by the study sponsor and principal investigator. Data will be shared for scientific research purposes only and under a data use agreement that ensures protection of participant confidentiality and intellectual property.

Locations

KA (1)