COVID-19 InfectionPhase 2AeroVaxNCT06381739
A Trial of a Next Generation COVID-19 Vaccine Delivered by Inhaled Aerosol
A Phase 2 study testing ChAd-triCoV/Mac in people with COVID-19 Infection, run by McMaster University at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Infection
- What is being tested?
- ChAd-triCoV/Mac
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 2 sitesCanada
- Study dates
- 25 Mar 2025to Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
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- 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)).
- Potential contraindication to COVID vaccination (e.g. venous or arterial thrombosis with thrombocytopenia after vaccination, history of cerebral venous thrombosis with thrombocytopenia, history of heparin induced thrombocytopenia, history of myocarditis or pericarditis).
- Known allergy to vaccine components or previous receipt of any experimental adenovirus-vector vaccine by the aerosol route.
- Enrolment in any clinical trial of experimental treatment for COVID infection within 90 days.
- For participants in the BAL sub-study, any health-related condition for which study bronchoscopy is contraindicated.
- For participants in the BAL sub-study, current use of anticoagulants.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Canadian Center for Vaccinology, Dalhousie University
Halifax, Nova Scotia, B3K 6R8
Study Coordinator, 902-470-3742
Scott Halperin, MD
- Recruiting
Health Sciences Centre
Hamilton, Ontario, L8S 4K1
About this study
Official title: A Phase 2 Trial to Evaluate Safety and Immunogenicity of a Next-generation COVID-19 Vaccine Delivered by Inhaled Aerosol to Humans
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.
Read more
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).
Read the detailed description
The global impact of the coronavirus disease 2019 (COVID-19) pandemic remains profound; COVID-19 continues to be one of the leading causes of death and hospitalization due to infectious disease, disproportionately affecting the elderly and immunocompromised. The continuous evolution of the virus has significantly challenged the effectiveness of first-generation and updated vaccination strategies. These variants of concern (VOCs) can evade neutralizing antibodies.
Adequate and early lung mucosal immunity is critical for control of infection but current vaccines fail to induce robust mucosal immunity in the lungs, a major reason for the high rates of break-through infections. The respiratory mucosal route of immunization, however, can induce protective respiratory mucosal immunity consisting of trained innate immunity (via memory airway macrophages), mucosal antibodies, and tissue-resident memory CD4+/CD8+ T cells.
A phase 1 study has been completed using a recombinant chimpanzee adenovirus (ChAd) vector, ChAd-CoV3/Mac in 23 healthy volunteers and has shown that the vaccine can be safely administered by aerosol and that immune responses against COVID-19 develop in the lung and T-cells and neutralizing antibodies are generated in the blood.
The purpose of this placebo-controlled Phase 2 trial is to determine if this new COVID-19 vaccine, ChAd-triCoV/Mac, is safe to give by aerosol to people who have been vaccinated with at least three doses of a COVID mRNA vaccine and evaluate the immune responses generated. Specifically, the researchers want to see if T cell responses and antibody responses to the COVID virus proteins develop in the blood after receiving the vaccine.
There is a lack of surrogate immune markers for vaccine-induced protection against antibody-evading VOCs of SARS-CoV-2. However, given the now recognized importance of respiratory mucosal T cell immunity in anti-SARS-CoV-2 host defense, this study will allow for a correlation of mucosal T cell immunity with the T cells in blood to help predict vaccine efficacy, and inform the design of phase 3 efficacy studies.
- Conditions
- COVID-19 Infection
- Being tested
- ChAd-triCoV/Mac, Control
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChAd-triCoV/MacBiological
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.
ControlOther
A single dose of placebo (0.5mL formulated buffer) will be aerosolized and inhaled as the intervention vaccine.
| Study group | Role | What they receive |
|---|---|---|
| ChAd-triCoV/Mac | Experimental | ChAd-triCoV/Mac Receives: Biological: ChAd-triCoV/Mac |
| Control | Placebo comparator | Placebo Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antigen specific T cell responses in blood.
Percentage of cytokine positive T cells in the blood
Measured: 2 weeks
Antigen specific T cell responses in bronchoalveolar lavage (BAL).
Percentage of cytokine positive T cells in the BAL
Measured: 4 weeks
Any grade 3, 4, or 5 adverse events that are possibly or probably related to study vaccine.
Frequency, incidence and nature of adverse events
Measured: 24 weeks
Secondary outcomes (5)
Confirmed COVID infection by reverse transcriptase polymerase chain reaction (RT-PCR)
Positive RT-PCR test
Measured: 24 weeks
CD4 and CD8 T cell responses specific for the spike (S1), nucleoprotein (N) and polymerase (POL) SARS-CoV-2 antigens expressed by the vaccine, including those expressing memory T cell markers, in the peripheral blood.
Percentage of cytokine positive T cells in the blood to specific antigens
Measured: 4 and 8 weeks
Neutralizing and total antibody levels in BAL and blood
Anti-receptor binding domain (RBD) IgG and IgA endpoint titre; percent neutralization (surrogate virus neutralization test [sVNT])
Measured: 2, 4 and 8 weeks
Any adverse events, including grade 1 or 2 or where relationship to vaccine/placebo administration or study procedures is judged not related or unlikely.
Frequency, incidence and nature of any adverse events
Measured: 24 weeks
Tissue-resident memory surface marker expression airway T cells
Percentage CD103+CD8+ specific cells
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start25 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Fiona Smaill, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381739
- Sponsor's protocol ID
- M011
- Acronym
- AeroVax
- Status last verified
- Jan 2026
- First submitted
- 23 Apr 2024
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The full protocol and details of laboratory analyses will be published within 6 months of study enrolment. The statistical analysis plan and individual participant data will be made available to qualified researchers on request.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial to Evaluate Safety and Immunogenicity of a Next-generation COVID-19 Vaccine Delivered by Inhaled Aerosol to Humans
- ClinicalTrials.gov ID
- NCT06381739
- Acronym / sponsor ID
- AeroVax / M011
- Conditions
- COVID-19 Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The global impact of the coronavirus disease 2019 (COVID-19) pandemic remains profound; COVID-19 continues to be one of the leading causes of death and hospitalization due to infectious disease, disproportionately affecting the elderly and immunocompromised. The continuous evolution of the virus has significantly challenged the effectiveness of first-generation and updated vaccination strategies. These variants of concern (VOCs) can evade neutralizing antibodies.
Adequate and early lung mucosal immunity is critical for control of infection but current vaccines fail to induce robust mucosal immunity in the lungs, a major reason for the high rates of break-through infections. The respiratory mucosal route of immunization, however, can induce protective respiratory mucosal immunity consisting of trained innate immunity (via memory airway macrophages), mucosal antibodies, and tissue-resident memory CD4+/CD8+ T cells.
A phase 1 study has been completed using a recombinant chimpanzee adenovirus (ChAd) vector, ChAd-CoV3/Mac in 23 healthy volunteers and has shown that the vaccine can be safely administered by aerosol and that immune responses against COVID-19 develop in the lung and T-cells and neutralizing antibodies are generated in the blood.
The purpose of this placebo-controlled Phase 2 trial is to determine if this new COVID-19 vaccine, ChAd-triCoV/Mac, is safe to give by aerosol to people who have been vaccinated with at least three doses of a COVID mRNA vaccine and evaluate the immune responses generated. Specifically, the researchers want to see if T cell responses and antibody responses to the COVID virus proteins develop in the blood after receiving the vaccine.
There is a lack of surrogate immune markers for vaccine-induced protection against antibody-evading VOCs of SARS-CoV-2. However, given the now recognized importance of respiratory mucosal T cell immunity in anti-SARS-CoV-2 host defense, this study will allow for a correlation of mucosal T cell immunity with the T cells in blood to help predict vaccine efficacy, and inform the design of phase 3 efficacy studies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ChAd-triCoV/Mac | Experimental | Biological: ChAd-triCoV/MacChAd-triCoV/Mac |
| Control | Placebo comparator | Other: ControlPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChAd-triCoV/MacClinical-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. | Biological | ChAd-triCoV/Mac |
| ControlA single dose of placebo (0.5mL formulated buffer) will be aerosolized and inhaled as the intervention vaccine. | Other | Control |
Primary outcome
Antigen specific T cell responses in blood.
Time frame: 2 weeks
Percentage of cytokine positive T cells in the blood
Antigen specific T cell responses in bronchoalveolar lavage (BAL).
Time frame: 4 weeks
Percentage of cytokine positive T cells in the BAL
Any grade 3, 4, or 5 adverse events that are possibly or probably related to study vaccine.
Time frame: 24 weeks
Frequency, incidence and nature of adverse events
5 secondary outcomes
Confirmed COVID infection by reverse transcriptase polymerase chain reaction (RT-PCR)
Time frame: 24 weeks
CD4 and CD8 T cell responses specific for the spike (S1), nucleoprotein (N) and polymerase (POL) SARS-CoV-2 antigens expressed by the vaccine, including those expressing memory T cell markers, in the peripheral blood.
Time frame: 4 and 8 weeks
Neutralizing and total antibody levels in BAL and blood
Time frame: 2, 4 and 8 weeks
Any adverse events, including grade 1 or 2 or where relationship to vaccine/placebo administration or study procedures is judged not related or unlikely.
Time frame: 24 weeks
Tissue-resident memory surface marker expression airway T cells
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: Yes. The full protocol and details of laboratory analyses will be published within 6 months of study enrolment. The statistical analysis plan and individual participant data will be made available to qualified researchers on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fiona Smaill principal investigator
McMaster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ChAd-triCoV/Mac in people with COVID-19 Infection, run by McMaster University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marilyn Swinton (289-244-3997, swinton@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antigen specific T cell responses in blood. (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.