A Trial of a Next Generation COVID-19 Vaccine Delivered by Inhaled Aerosol (NCT06381739)
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (17 items).
Location: Canadian Center for Vaccinology, Dalhousie University — Halifax, Nova Scotia
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion criteria:
- Failure to provide informed consent.
- Women who are pregnant or breastfeeding.
- Have received any recombinant adenoviral-vectored COVID-19 vaccine (AstraZeneca \[Vaxzeria\] or Johnson \& Johnson (Janssen Jcovden).
- COVID infection (positive PCR or antigen (Ag) test, self-reported or lab documented) within the last 90 days.
- Last dose of a COVID vaccine administered less than 90 days prior to study entry.
- Administration of any vaccine within 2 weeks of study entry.
- Active pulmonary disease diagnosed by a physician including asthma, chronic bronchitis, interstitial lung disease, pulmonary hypertension, lung cancer, cystic fibrosis, or bronchiectasis. Current use of daily inhaled steroids for any condition.
- Persons with HIV and a detectable HIV viral load (\>20 copies/mL), self-reported or confirmed.
- Administration of monoclonal antibodies for treatment of COVID-19 infection within 3 months.
- Moderately or severely immunocompromised (e.g. transplant recipients/CAR-T cell therapy, currently on chemotherapy for cancer or on potent immunosuppressant therapies e.g. rituximab or high dose steroids \[\>30 mg of prednisone equivalent daily\], or moderate or severe primary immunodeficiency syndrome).
- History of severe reaction to previous COVID vaccination (e.g. hives, difficulty breathing, high fever, seizures, myocarditis, pericarditis)).
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (2 Sites)
- Canadian Center for Vaccinology, Dalhousie University — Halifax, Nova Scotia
- Health Sciences Centre — Hamilton, Ontario
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.