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

NCT06381739 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2026-01-26

No results posted yet for this study

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).

Conditions

  • COVID-19 Infection

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.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • McMaster University

    lead OTHER

Principal Investigators

  • Fiona Smaill · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-25
Primary Completion
2026-12-31
Completion
2027-01-31

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06381739 on ClinicalTrials.gov