A Trial of a Next Generation COVID-19 Vaccine Delivered by Inhaled Aerosol (NCT06381739) | Clinical Trial Compass
RecruitingPhase 2
A Trial of a Next Generation COVID-19 Vaccine Delivered by Inhaled Aerosol
Canada350 participantsStarted 2025-03-25
Plain-language 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).
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults who are 18-65 years old on the day of randomization (day 1)
. Able to read, write and communicate using the English or French language.
. Received at least 3 doses of an mRNA COVID vaccine.
. Individuals of childbearing potential must have a negative pregnancy test prior to vaccination and be willing to practice effective contraception for 8 weeks post-vaccination.
. Able to understand and comply with protocol requirements and instructions; able to report adverse events; able to attend scheduled study visits and complete required investigations.
. For participants in the BAL sub-study, Complete Blood Count (CBC) and chemistry (creatinine) within normal limits.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Antigen specific T cell responses in blood.
Timeframe: 2 weeks
2
Antigen specific T cell responses in bronchoalveolar lavage (BAL).
Timeframe: 4 weeks
3
Any grade 3, 4, or 5 adverse events that are possibly or probably related to study vaccine.
. For participants in the BAL sub-study, forced expiratory volume in 1 second (FEV1) \> the lower limit of normal (LLN), and FEV1/FVC (forced expiratory volume in 1 second/forced vital capacity) ratio above the LLN.
. Agree not to enroll in any other intervention studies for the duration of the study where the intervention could be reasonably expected to be associated with adverse events overlapping with the inhaled vaccine or the immune responses being measured.
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.