Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-01-15 @ 3:34 AM
Study NCT ID:
NCT07215520
Status:
RECRUITING
Last Update Posted:
2025-11-06
First Post:
2025-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults
Sponsor:
CastleVax Inc.
Organization:
Study Overview
Official Title:
A Double-blind, Randomized, Controlled, Phase 2a Study to Evaluate the Safety and Tolerability of a Newcastle Disease Virus-based Mucosal Vaccine (NDV-HXP-S-KP.2) Relative to an Approved Systemic mRNA Vaccine in Previously Vaccinated Adults
Status:
RECRUITING
Status Verified Date:
2025-11
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:
A Double-blind, Randomized, Controlled, Phase 2a Study to Evaluate the Safety and Tolerability of a Newcastle Disease Virus-based Mucosal Vaccine (NDV-HXP-S-KP.2) Relative to an Approved Systemic mRNA Vaccine in Previously Vaccinated Adults
Detailed Description:
This is a double-blind (supported by a double-dummy design), randomized, active comparator-controlled Phase 2a safety and tolerability study. The study will enroll approximately 200 previously COVID-19-vaccinated, male and nonpregnant female adult participants aged ≥18 years. Participants 18 through 64 years of age must have at least 1 underlying condition that puts them at high risk for severe outcomes from COVID-19
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?: