Actively Recruiting
A Phase 2 Trial to Evaluate Safety and Immunogenicity of a Next-generation COVID-19 Vaccine Delivered by Inhaled Aerosol to Humans
Led by McMaster University · Updated on 2026-01-26
350
Participants Needed
2
Research Sites
4 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
Researchers are evaluating the safety and immune response of a new inhaled COVID-19 vaccine called ChAd-triCoV/Mac. This vaccine is designed to improve lung mucosal immunity, which current vaccines do not adequately induce, especially against evolving variants. The study focuses on adults aged 18 to 65 who have already received at least three doses of an mRNA COVID vaccine and are generally healthy. Participants will be randomly assigned to receive either the experimental inhaled vaccine or a placebo. The vaccine dose is given as a fine mist inhaled directly into the lungs using a nebulizer. Some participants will also undergo a bronchoscopy to collect lung cells four weeks after vaccination. The study includes a placebo-controlled design with careful monitoring of immune responses and safety. During the study, participants will attend clinic visits for checkups and blood tests at 2, 4, and 8 weeks after vaccination. They will report any symptoms for 24 weeks. Researchers will measure specific T cell responses in blood and lung samples, antibody levels, and any adverse events possibly related to the vaccine. The study will help predict vaccine efficacy and guide future vaccine development. Total follow-up lasts 24 weeks after vaccination.
CONDITIONS
Brief 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 who are 18-65 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 prior to vaccination and willing to use effective contraception for 8 weeks post-vaccination if of childbearing potential
- Able to understand and follow study instructions, report adverse events, attend scheduled visits, and complete required tests
- For bronchoalveolar lavage (BAL) sub-study participants: normal Complete Blood Count and kidney function tests
- For BAL sub-study participants: lung function tests (FEV1 and FEV1/FVC ratio) above lower limits of normal
- Agree not to join other intervention studies with overlapping risks during this study
You will not qualify if you...
- Unable to give informed consent
- Pregnant or breastfeeding women
- Received any recombinant adenoviral-vectored COVID-19 vaccine (AstraZeneca or Johnson & Johnson)
- COVID infection within the last 90 days
- Received a COVID vaccine dose less than 90 days before study entry
- Received any vaccine within 2 weeks before study entry
- Active lung diseases like asthma, chronic bronchitis, interstitial lung disease, pulmonary hypertension, lung cancer, cystic fibrosis, or bronchiectasis
- Current daily use of inhaled steroids
- Detectable HIV viral load
- Received monoclonal antibodies for COVID-19 treatment within 3 months
- Moderately or severely immunocompromised conditions or treatments
- History of severe reactions to previous COVID vaccination
- Contraindications to COVID vaccination such as certain clotting or heart inflammation disorders
- Allergy to vaccine components or previous experimental adenovirus-vector vaccine by inhalation
- Participation in any experimental COVID-19 treatment trial within 90 days
- Health conditions or medications contraindicating bronchoscopy for BAL sub-study
- Current use of anticoagulants for BAL sub-study participants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single dose of the COVID-19 vaccine or placebo by inhaled aerosol.
1 vaccination visit (in-person)
Duration - Up to 24 weeks
Participants are monitored for immune responses and any adverse events for up to 24 weeks after vaccination.
Multiple follow-up visits over 24 weeks including blood and bronchoalveolar lavage sample collections
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here