Aerosolized Adenovirus COVID-19 Vaccines for COVID-19

Overseen By Zhou Xing, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: McMaster University

Must not be taking: Immunosuppressants, Inhaled steroids

Disqualifiers: Respiratory diseases, Smoking, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

36 Participants Needed

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.

Research Team

Fiona M Smaill, MD

Principal Investigator

McMaster University

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 am not pregnant and will use two forms of birth control during the study.

I have received three doses of an mRNA COVID vaccine over 3 months ago.

Exclusion Criteria

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

I have never received an experimental adenovirus vaccine through inhalation.

You have breathing tests that show significant abnormalities, such as low lung capacity or difficulty moving air in and out of your lungs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of either Ad5-triCoV/Mac or ChAd-triCoV/Mac vaccine via inhaled aerosol, with dose escalation based on safety and immunogenicity

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and immunogenicity, with assessments at multiple time points including 48-72 hours post-vaccination and up to 48 weeks

48 weeks

Multiple visits (in-person and virtual)

Extension

Potential continuation of monitoring or additional dosing based on immunogenicity outcomes

As required

Treatment Details

Interventions

• Ad5-triCoV/Mac
• ChAd-triCoV/Mac

Trial Overview 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.

Participant Groups

Group I: ChAd-triCoV/Mac at a dose level of 3x10e7 Experimental Treatment 1 Intervention

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

Group II: Aerosol ChAd-triCoV/Mac dose level 6x10e7 Experimental Treatment 1 Intervention

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

Group III: Aerosol ChAd-triCoV/Mac dose level 1x10e8 Experimental Treatment 2 Interventions

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

Group IV: Aerosol ChAd-triCoV/Mac dose level 10e7 Experimental Treatment 1 Intervention

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

Group V: Aerosol ChAd-triCoV/Mac dose level 10e6 Experimental Treatment 1 Intervention

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

Group VI: Aerosol ChAd-tri-CoV/Mac dose level 10e5 Experimental Treatment 1 Intervention

Single dose by inhalation of 10e5 ChAd-triCoV/Mac

Group VII: Aerosol Ad5-triCoV/Mac dose level 3x10e7 Experimental Treatment 1 Intervention

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

Group VIII: Aerosol Ad5-triCoV/Mac dose level 10e7 Experimental Treatment 1 Intervention

Single dose by inhalation of 10e7 Ad5-triCoV/Mac

Group IX: Aerosol Ad5-triCoV/Mac dose level 10e6 Experimental Treatment 1 Intervention

Single dose by inhalation of 10e6 Ad5-triCoV/Mac

Group X: Aerosol Ad5-triCoV/Mac dose level 10e5 Experimental Treatment 1 Intervention

Single dose by inhalation of 10e5 Ad5-tri-CoV/Mac

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+