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RECRUITING
NCT06381739
PHASE2

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

Sponsor: McMaster University

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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.

OTHER

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