Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:44 AM
Study NCT ID:
NCT07317960
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-05
First Post:
2025-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study of PollenVax in Patients With Mugwort Pollen-Induced Allergic Rhinitis
Sponsor:
Kazakh National Agrarian University
Organization:
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| BR25293305 | OTHER_GRANT | The Ministry of Health of the Republic of Kazakhstan | View |