NCT07215520

Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: CastleVax Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	NDV-HXP-S-KP.2	Nasal Administration of a COVID-19 vaccine to compare against a commercially available mRNA vaccine
BIOLOGICAL	COVID-19 mRNA Vaccine	Used as a comparator to study vaccine

Timeline

• Start date: 2025-11-03
• Primary completion: 2026-08-19
• Completion: 2026-08-19
• First posted: 2025-10-10
• Last updated: 2025-11-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study