Actively Recruiting
A Trial of a Next Generation COVID-19 Vaccine Delivered by Inhaled Aerosol
Led by McMaster University · Updated on 2026-01-26
350
Participants Needed
2
Research Sites
92 weeks
Total Duration
On this page
Sponsors
M
McMaster University
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Trial of a Next Generation COVID-19 Vaccine Delivered by Inhaled Aerosol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 to 65 years old on the day of randomization
- Able to read, write, and communicate in English or French
- Received at least 3 doses of an mRNA COVID vaccine
- Negative pregnancy test before vaccination and willing to use effective contraception for 8 weeks if of childbearing potential
- Able to understand and follow study instructions, report side effects, attend visits, and complete tests
- For bronchoalveolar lavage (BAL) sub-study participants: normal blood counts and kidney function
- For BAL sub-study participants: lung function within normal limits (FEV1 and FEV1/FVC ratio above lower limit)
- Agree not to join other intervention studies with overlapping risks during this study
You will not qualify if you...
- Unable or unwilling to provide informed consent
- Pregnant or breastfeeding women
- Received any adenoviral-vectored COVID-19 vaccine (e.g., AstraZeneca or Johnson & Johnson)
- COVID-19 infection within the last 90 days
- Last COVID vaccine dose given less than 90 days before study entry
- Received any vaccine within 2 weeks before study entry
- Active lung diseases diagnosed by a doctor, including asthma, chronic bronchitis, interstitial lung disease, pulmonary hypertension, lung cancer, cystic fibrosis, or bronchiectasis
- Current daily use of inhaled steroids
- HIV infection with detectable viral load over 20 copies/mL
- Received monoclonal antibodies for COVID-19 treatment within last 3 months
- Moderately or severely immunocompromised status
- History of severe reactions to previous COVID vaccines
- Conditions that contraindicate COVID vaccination such as blood clotting disorders or myocarditis history
- Allergy to vaccine components or prior experimental adenovirus-vector vaccines by inhalation
- Participation in another experimental COVID treatment trial within last 90 days
- For BAL sub-study participants: any condition preventing safe bronchoscopy or current use of blood thinners
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Canadian Center for Vaccinology, Dalhousie University
Halifax, Nova Scotia, Canada, B3K 6R8
Actively Recruiting
2
Health Sciences Centre
Hamilton, Ontario, Canada, L8S 4K1
Actively Recruiting
Research Team
M
Marilyn Swinton
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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