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

Trial Summary

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.

What data supports the effectiveness of the treatment ChAd-triCoV/Mac for COVID-19?

Research on similar treatments, like the ChAd-SARS-CoV-2-S vaccine, shows that a single intranasal dose can produce strong immune responses and significantly reduce COVID-19 infection in the respiratory tract. This suggests that inhaled vaccines using similar technology could be effective in preventing COVID-19. ^{1 2 3 4 5}

Is the inhaled COVID-19 vaccine safe for humans?

The inhaled COVID-19 vaccine, evaluated in preclinical studies, showed excellent safety profiles in animals like mice, rats, hamsters, and rabbits, with no serious adverse effects reported. ^{1 3 6 7 8}

How is the inhaled vaccine ChAd-triCoV/Mac different from other COVID-19 treatments?

The inhaled vaccine ChAd-triCoV/Mac is unique because it is administered intranasally (through the nose) rather than by injection, which helps induce strong immune responses in the respiratory tract, potentially preventing both infection and transmission of COVID-19. ^{1 2 5 9 10}

What is the purpose of this trial?

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).

Research Team

Fiona Smaill

Principal Investigator

McMaster University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

A Single-Dose Intranasal ChAd Vaccine Protects Upper and Lower Respiratory Tracts against SARS-CoV-2. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A single intranasal dose of chimpanzee adenovirus-vectored vaccine protects against SARS-CoV-2 infection in rhesus macaques. [2023]

3. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of heterologous ChAdOx1 nCoV-19 and recombinant subunit vaccine MVC-COV1901 against COVID-19. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Heterologous immunization with adenovirus vectored and inactivated vaccines effectively protects against SARS-CoV-2 variants in mice and macaques. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Neutralizing antibody and T-cell responses against SARS-CoV-2 variants by heterologous CoronaVac/ChAdOx-1 vaccination in elderly subjects with chronic obstructive pulmonary disease. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Phase 3 Safety and Efficacy of AZD1222 (ChAdOx1 nCoV-19) Covid-19 Vaccine. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Preclinical evaluation of safety and immunogenicity of a primary series intranasal COVID-19 vaccine candidate (BBV154) and humoral immunogenicity evaluation of a heterologous prime-boost strategy with COVAXIN (BBV152). [2023]

9. United States pubmed.ncbi.nlm.nih.gov

A single intranasal dose of chimpanzee adenovirus-vectored vaccine protects against SARS-CoV-2 infection in rhesus macaques. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Characterization of immune responses to two and three doses of the adenoviral vectored vaccine ChAdOx1 nCov-19 and the whole virion inactivated vaccine BBV152 in a mix-and-match study in India. [2023]