RecruitingPhase 2NCT06381739

A Trial of a Next Generation COVID-19 Vaccine Delivered by Inhaled Aerosol

A Phase 2 Trial to Evaluate Safety and Immunogenicity of a Next-generation COVID-19 Vaccine Delivered by Inhaled Aerosol to Humans


Sponsor

McMaster University

Enrollment

350 participants

Start Date

Mar 25, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called ChAd-triCoV/Mac and Control for people with covid-19 infection. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALChAd-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.

OTHERControl

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

View Full Details on ClinicalTrials.gov

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NCT06381739


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