Inhaled Vaccine for COVID-19

(AeroVax Trial)

Overseen By Marilyn Swinton

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: McMaster University

Must not be taking: Inhaled steroids, Monoclonal antibodies

Disqualifiers: Pregnancy, Active pulmonary disease, HIV, Immunocompromised, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 1 day

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new inhaled COVID-19 vaccine, ChAd-triCoV/Mac, to evaluate its safety and effects on the immune system in the lungs and blood. Participants will receive either the experimental vaccine or a placebo, which is a look-alike solution without the active vaccine. The study seeks generally healthy individuals who have already received three doses of an mRNA COVID vaccine. Participants must attend several clinic visits and report symptoms for 24 weeks. Some will also undergo a procedure to collect lung cells for studying their immune response. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important vaccine development.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using daily inhaled steroids or are on potent immunosuppressant therapies, you may not be eligible to participate.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that the ChAd-triCoV/Mac vaccine, administered via inhalation, is under study to determine its safety and ability to trigger an immune response in the lungs. In earlier studies, participants received this vaccine without major problems. It uses a non-replicating virus to help the body learn to fight COVID-19 without causing illness.

Another study found that similar vaccines given as sprays were generally well-tolerated, with most participants not experiencing serious side effects. As a Phase 2 trial, the vaccine has already been tested in a smaller group with no major safety concerns, indicating it may be safe for a larger population.

Prospective participants can feel reassured that the vaccine has undergone earlier testing stages. Most individuals handled it well, which is promising for future tests. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard COVID-19 vaccines, which are typically injected, the ChAd-triCoV/Mac vaccine is inhaled, offering a needle-free alternative that could be more appealing to those with needle anxiety. This inhaled method targets the respiratory tract directly, which might enhance the local immune response where the virus first enters the body. Researchers are excited about this approach because it could not only simplify the vaccination process but also potentially provide stronger and faster protection against COVID-19.

What evidence suggests that this inhaled vaccine is effective for preventing COVID-19?

Research has shown that the ChAd-triCoV/Mac vaccine, which participants in this trial may receive, could help prevent COVID-19. Studies have found that this inhaled vaccine generates strong immune responses in the lungs and blood, crucial for fighting infections. Earlier research demonstrated that both the ChAd-triCoV/Mac and a similar vaccine are very safe and effective. These findings suggest that the vaccine could be a good option for boosting immunity against COVID-19. Overall, early signs are positive, indicating that this vaccine might help strengthen the body's defenses against the virus. ^{1 2 3 4 6}

Who Is on the Research Team?

Fiona Smaill

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

This trial is for people who have already received three doses of an mRNA COVID vaccine and are in good health. They will inhale a mist containing either the new ChAd-triCoV/Mac vaccine or a placebo, with no active ingredients.

Inclusion Criteria

I have received 3 or more doses of an mRNA COVID vaccine.

For participants in the BAL sub-study, Complete Blood Count (CBC) and chemistry (creatinine) within normal limits

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

I have no health conditions that prevent me from undergoing a bronchoscopy.

I am currently taking blood thinners.

History of severe reaction to previous COVID vaccination (e.g. hives, difficulty breathing, high fever, seizures, myocarditis, pericarditis)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of the experimental vaccine or placebo by inhaled aerosol

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and immune responses, including clinic visits and blood tests at 2, 4, and 8 weeks, and symptom reporting for 24 weeks

24 weeks

3 visits (in-person) at 2, 4, and 8 weeks

Bronchoscopy

In some participants, cells are collected from the lung 4 weeks after vaccination

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ChAd-triCoV/Mac

Trial Overview

The study tests the safety and immune response to an experimental COVID-19 vaccine delivered as an aerosol directly into the lungs. Participants will be randomly assigned to receive either this new vaccine or a placebo.

How Is the Trial Designed?

Group I: ChAd-triCoV/Mac Experimental Treatment 1 Intervention

ChAd-triCoV/Mac

Group II: Control Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12147143/

AeroVax: study protocol for a randomised, double-blind ...

This placebo-controlled phase 2 randomised trial will test the safety and immunogenicity of an inhaled, nebulised ChAd-triCoV/Mac SARS-CoV-2 ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05094609

Phase 1 Trial of ChAd68 and Ad5 Adenovirus COVID-19 ...

This is a phase 1, dose-escalating study to evaluate the safety and immunogenicity of a single dose of either Ad5-triCoV/Mac, a replication deficient human ...

3.

nature.com

nature.com/articles/s41467-025-60726-0

Induction of lung mucosal immunity by a next-generation ...

Both HuAd-TriCoV/Mac (HuAd) and ChAd-TriCoV/Mac (ChAd) vaccines have demonstrated excellent safety, immunogenicity, and efficacy against both ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0264410X25008990

Review Mucosal COVID-19 vaccines in clinical development

To identify mucosal COVID-19 vaccines in clinical trials, we performed an initial screening of commonly used data bases for clinical trials ( ...

5.

withpower.com

withpower.com/trial/phase-2-covid-19-infection-5-2024-79ad5

Inhaled Vaccine for COVID-19 (AeroVax Trial)

The AeroVax medical study, being run by McMaster University, is evaluating whether ChAd-triCoV/Mac will have tolerable side effects & efficacy for patients ...

6.

publications.ersnet.org

publications.ersnet.org/content/erjor/11/3/00758-2024.abstract

AeroVax: study protocol for a randomised, double-blind ...

This placebo-controlled phase 2 randomised trial will test the safety and immunogenicity of an inhaled, nebulised ChAd-triCoV/Mac SARS-CoV-2 vaccine.