Aerosolized Adenovirus COVID-19 Vaccines for COVID-19

Recruiting in Palo Alto (17 mi)

Overseen ByFiona M Smaill, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: McMaster University

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests two new vaccines on healthy people who have previously received COVID-19 vaccinations to see if their immune response can be improved. The vaccines use a harmless virus to deliver parts of the COVID-19 virus, helping the body recognize and defend against it.

Eligibility Criteria

Healthy adults aged 18-65 who've had at least three mRNA COVID-19 vaccine doses can join this trial. They must not be pregnant, agree to use contraception, have no history of severe COVID or certain respiratory diseases, and cannot be current smokers or recent ex-smokers.

Inclusion Criteria

I am between 18 and 65 years old and healthy.

I will use barrier contraception throughout the study.

Exclusion Criteria

I've had blood clots and low platelet counts after a vaccination.

I have never received an experimental adenovirus vaccine through inhalation.

I have a lung condition like asthma or COPD that needs regular treatment.

I do not have any health conditions that prevent me from undergoing a bronchoscopy.

I have had blood clots in my brain with low platelet counts.

I have had myocarditis or pericarditis in the past.

I currently smoke cigarettes or e-cigarettes, or I quit less than a year ago.

I have had Bell's Palsy in the past.

I have received an adenoviral COVID-19 vaccine like AstraZeneca.

I was hospitalized due to COVID.

Participant Groups

The trial is testing two experimental adenovirus-based COVID-19 vaccines delivered by aerosol: Ad5-triCoV/Mac and ChAd-triCoV/Mac. It aims to assess safety and immune responses in the blood and lungs after administration.

10Treatment groups

Experimental Treatment

Group I: ChAd-triCoV/Mac at a dose level of 3x10e7Experimental Treatment1 Intervention

Single dose by inhalation of 3x10e7 Ad5-triCoV/Mac

Group II: Aerosol ChAd-triCoV/Mac dose level 6x10e7Experimental Treatment1 Intervention

Single dose by inhalation of 6x10e7 ChAd-triCoV/Mac

Group III: Aerosol ChAd-triCoV/Mac dose level 1x10e8Experimental Treatment2 Interventions

Single dose by inhalation of 1x10e8 ChAd-triCoV/Mac

Group IV: Aerosol ChAd-triCoV/Mac dose level 10e7Experimental Treatment1 Intervention

Single dose by inhalation of 10e7 ChAd-triCoV/Mac

Group V: Aerosol ChAd-triCoV/Mac dose level 10e6Experimental Treatment1 Intervention

Single dose by inhalation of 10e6 ChAd-triCoV/Mac