What side effects are associated with this type of intervention?

Common treatments for COVID-19 include antiviral drugs, immunotherapies, and vaccines. Adenovirus vector vaccines, such as Ad5-triCoV/Mac or ChAd-triCoV/Mac, are designed to elicit an immune response by delivering SARS-CoV-2 proteins. Known side effects of these vaccines can include mild to moderate symptoms such as fever, fatigue, headache, muscle pain, chills, and injection site reactions (pain, redness, swelling). Severe side effects are rare but can include allergic reactions and, in very rare cases, blood clotting disorders.

What prior FDA approvals exist?

The FDA has granted Emergency Use Authorization (EUA) for several COVID-19 vaccines, including adenovirus vector-based vaccines like the Johnson & Johnson's Janssen COVID-19 vaccine, which uses a human adenovirus vector to deliver the SARS-CoV-2 spike protein. Additionally, mRNA vaccines such as Pfizer-BioNTech and Moderna have been approved, which use lipid nanoparticles to deliver mRNA encoding the spike protein. These vaccines aim to elicit an immune response to protect against COVID-19. Other treatments, such as antiviral drugs like remdesivir, have also received FDA approval for treating COVID-19.

What other types of research exist?

Promising alternatives to Ad5-triCoV/Mac or ChAd-triCoV/Mac for COVID-19 treatment in 2024 include mRNA vaccines like BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna), which have demonstrated high efficacy and safety. Additionally, NVX-CoV2373 (Novavax), a protein subunit vaccine, and therapeutic approaches such as monoclonal antibodies (e.g., sotrovimab) and antiviral drugs (e.g., nirmatrelvir/ritonavir) are also promising options.

← Back to Search

Virus Therapy

Aerosolized Adenovirus COVID-19 Vaccines for COVID-19

Phase 1

Waitlist Available

Led By Fiona M Smaill, MD

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy human subjects who are between 18 and 65 years of age

Healthy human subjects who are between 18 and 65 years of age.

Must not have

History of venous or arterial thrombosis with thrombocytopenia following any vaccination

Previous receipt of any experimental adenovirus-vector vaccine by the aerosol route

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over 48 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include typical vaccine reactions like soreness at the site of inhalation, headache, fever, fatigue, muscle pain. Since it's a Phase 1 trial assessing safety, close monitoring for any unexpected reactions will occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old and healthy.

Select...

I am between 18 and 65 years old and healthy.

Select...

I will use barrier contraception throughout the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have never received an experimental adenovirus vaccine through inhalation.

Select...

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

Select...

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

Select...

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

Select...

I have had myocarditis or pericarditis in the past.

Select...

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

Select...

I have had Bell's Palsy in the past.

Select...

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

Select...

I was hospitalized due to COVID.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over 48 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~over 48 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and over 48 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants reporting adverse events and severity of adverse events following Ad5-triCoV/Mac vaccination

Number of participants reporting adverse events and severity of adverse events following ChAd-triCoV/Mac vaccination

Secondary study objectives

Correlation of antibodies measured in saliva with antibodies measured in BAL fluid and blood

Immune response to Ad5-triCoV/Mac and ChAd-triCoV/Mac correlated with pre-existing adenovirus antibodies

Immunogenicity of Ad5-triCoV/Mac administered by aerosol

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Group VI: Aerosol ChAd-tri-CoV/Mac dose level 10e5Experimental Treatment1 Intervention

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

Group VII: Aerosol Ad5-triCoV/Mac dose level 3x10e7Experimental Treatment1 Intervention

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

Group VIII: Aerosol Ad5-triCoV/Mac dose level 10e7Experimental Treatment1 Intervention

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

Group IX: Aerosol Ad5-triCoV/Mac dose level 10e6Experimental Treatment1 Intervention

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

Group X: Aerosol Ad5-triCoV/Mac dose level 10e5Experimental Treatment1 Intervention

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

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Adenovirus vector vaccines, such as Ad5-triCoV/Mac or ChAd-triCoV/Mac, work by using a modified adenovirus to deliver genetic material encoding SARS-CoV-2 proteins (spike, nucleocapsid, and RNA polymerase) into host cells. These cells then produce the viral proteins, which trigger an immune response, including antibody production and T-cell activation. This immune response helps the body recognize and fight the virus if exposed in the future, reducing the severity and spread of COVID-19. This mechanism is vital for COVID-19 patients as it builds immunity without causing the disease.

The race to treat COVID-19: Potential therapeutic agents for the prevention and treatment of SARS-CoV-2.