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

NCT07317960 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-01-05

No results posted yet for this study

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

Interventions

BIOLOGICAL

PollenVax

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.

OTHER

Placebo

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

Sponsors & Collaborators

  • Kazakh National Agrarian University

    lead OTHER

Principal Investigators

  • Tair Nurpeissov · Limited Liability Partnership "Medcenter-Rakhat"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-22
Primary Completion
2026-01-14
Completion
2026-01-19

Countries

  • Kazakhstan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07317960 on ClinicalTrials.gov