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

Part of paid clinical trials in Colorado Springs, Colorado.

Sponsor
CastleVax Inc.
Study ID
NCT07215520
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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

Key Dates

Start date
Nov 3, 2025
Status verified
Nov 2025
Primary completion
Aug 19, 2026
Completion
Aug 19, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: IN administration of study drug plus placebo via IM
    Nasal Administration of NDV-HXP-S-KP.2 and administration of placebo via Intramuscular Injection
  • Active Comparator: IN administration of placebo plus COVID-19 vaccine via IM
    Nasal Administration of Placebo plus administration of COVID-19 mRNA vaccine via Intramuscular Injection

Primary Outcome Measure

Safety and Tolerability of the NDV-HXP-S-KP.2 Vaccine Compared With an Approved mRNA COVID-19 Vaccine [ Time Frame: Up to 180 days after vaccination ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Skylight Health ResearchColorado SpringsColorado80917
Skylight Health Research
[email protected]
719-301-7162
Deirdre Burke, NP (PRINCIPAL_INVESTIGATOR)
Skylight Health ResearchBurlingtonMassachusetts01803
Deirdre Burke, NP, MPH
[email protected]
717-483-2329
Deirdre Burke, NP, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Colorado Springs, CO

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Skylight Health Research· Colorado Springs, COSkylight Health Research· Burlington, MA

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