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A Trial of a Next Generation COVID-19 Vaccine Delivered by Inhaled Aerosol
Sponsor: McMaster University
Summary
The goal of this clinical trial is to study the safety of a new inhaled vaccine to prevent COVID infection and learn about the immune responses that are made in the lungs and the blood after vaccination. Participants will be randomized (like the toss of a coin) to receive the experimental vaccine or a placebo (a look-alike solution that contains no vaccine). To be in the study participants will have to have already had three doses of a messenger ribonucleic acid (mRNA) COVID vaccine and be generally healthy. Participants are given a single dose of the vaccine by breathing in a fine mist that goes directly into the lungs. During follow-up participants will: * visit the clinic for checkups and blood tests at 2, 4 and 8 weeks after vaccination * report their symptoms for 24 weeks after getting the vaccine. In some participants, the researchers will collect cells from the lung 4 weeks after vaccination (a test known as a bronchoscopy).
Official title: A Phase 2 Trial to Evaluate Safety and Immunogenicity of a Next-generation COVID-19 Vaccine Delivered by Inhaled Aerosol to Humans
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2025-03-25
Completion Date
2027-01
Last Updated
2026-01-26
Healthy Volunteers
Yes
Conditions
Interventions
ChAd-triCoV/Mac
Clinical-grade, fully certified ChAd-triCoV/Mac produced according to current Good Manufacturing Principles (cGMP) will be provided. A single dose of ChAd-triCoV/Mac diluted in 0.5mL formulated buffer will be aerosolized and inhaled via a mouthpiece and tidal breathing over approximately 2 minutes using the AeroNeb Solo Mesh Nebulizer.
Control
A single dose of placebo (0.5mL formulated buffer) will be aerosolized and inhaled as the intervention vaccine.
Locations (2)
Canadian Center for Vaccinology, Dalhousie University
Halifax, Nova Scotia, Canada
Health Sciences Centre
Hamilton, Ontario, Canada