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Virus Therapy

Aerosolized Adenovirus COVID-19 Vaccines for COVID-19

Phase 1
Recruiting
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
For women, negative pregnancy test and for those women of child-bearing potential practising two acceptable forms of contraception for the duration of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 48 weeks
Awards & highlights

Study Summary

This trial will test two different experimental coronavirus vaccines to see if they are safe and if they create an immune response in the blood and lungs.

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.Check my eligibility
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.See study design
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
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I am between 18 and 65 years old and healthy.
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I am not pregnant and will use two forms of birth control during the study.
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I have received three doses of an mRNA COVID vaccine over 3 months ago.
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I have never had COVID or had it over 6 months ago with proof.
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I can follow study rules and attend all required visits.
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I am between 18 and 65 years old and healthy.
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I will use barrier contraception throughout the study.
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I will use barrier methods of contraception throughout the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 48 weeks post vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and over 48 weeks post vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

Trial Design

9Treatment groups
Experimental Treatment
Group I: Aerosol ChAd-triCoV/Mac dose level 6x10e7Experimental Treatment1 Intervention
Single dose by inhalation of 6x10e7 ChAd-triCoV/Mac
Group II: Aerosol ChAd-triCoV/Mac dose level 1x10e8Experimental Treatment2 Interventions
Single dose by inhalation of 1x10e8 ChAd-triCoV/Mac
Group III: Aerosol ChAd-triCoV/Mac dose level 10e7Experimental Treatment1 Intervention
Single dose by inhalation of 10e7 ChAd-triCoV/Mac
Group IV: Aerosol ChAd-triCoV/Mac dose level 10e6Experimental Treatment1 Intervention
Single dose by inhalation of 10e6 ChAd-triCoV/Mac
Group V: Aerosol ChAd-tri-CoV/Mac dose level 10e5Experimental Treatment1 Intervention
Single dose by inhalation of 10e5 ChAd-triCoV/Mac
Group VI: Aerosol Ad5-triCoV/Mac dose level 3x10e7Experimental Treatment1 Intervention
Single dose by inhalation of 3x10e7 Ad5-triCoV/Mac
Group VII: Aerosol Ad5-triCoV/Mac dose level 10e7Experimental Treatment1 Intervention
Single dose by inhalation of 10e7 Ad5-triCoV/Mac
Group VIII: Aerosol Ad5-triCoV/Mac dose level 10e6Experimental Treatment1 Intervention
Single dose by inhalation of 10e6 Ad5-triCoV/Mac
Group IX: Aerosol Ad5-triCoV/Mac dose level 10e5Experimental Treatment1 Intervention
Single dose by inhalation of 10e5 Ad5-tri-CoV/Mac

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

McMaster UniversityLead Sponsor
879 Previous Clinical Trials
2,596,986 Total Patients Enrolled
18 Trials studying COVID-19
148,427 Patients Enrolled for COVID-19
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,336 Previous Clinical Trials
25,751,078 Total Patients Enrolled
31 Trials studying COVID-19
361,844 Patients Enrolled for COVID-19
Fiona M Smaill, MDPrincipal InvestigatorMcMaster University
1 Previous Clinical Trials
24 Total Patients Enrolled

Media Library

Ad5-triCoV/Mac (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05094609 — Phase 1
COVID-19 Research Study Groups: Aerosol ChAd-tri-CoV/Mac dose level 10e5, Aerosol Ad5-triCoV/Mac dose level 10e7, Aerosol Ad5-triCoV/Mac dose level 10e5, Aerosol Ad5-triCoV/Mac dose level 10e6, Aerosol ChAd-triCoV/Mac dose level 1x10e8, Aerosol ChAd-triCoV/Mac dose level 10e7, Aerosol ChAd-triCoV/Mac dose level 10e6, Aerosol Ad5-triCoV/Mac dose level 3x10e7, Aerosol ChAd-triCoV/Mac dose level 6x10e7
COVID-19 Clinical Trial 2023: Ad5-triCoV/Mac Highlights & Side Effects. Trial Name: NCT05094609 — Phase 1
Ad5-triCoV/Mac (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05094609 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric patients being admitted to this experiment?

"The age range for enrollment in this medical study is 18-65 years old, as stipulated by the trial's inclusion criteria."

Answered by AI

What aims does this clinical trial seek to accomplish?

"The primary objective of this 48-week trial is to assess adverse events and their intensity following ChAd-triCoV/Mac vaccination. Secondary analyses will determine correlations between antibodies in saliva, bronchioalveolar lavage (BAL) fluid, and serum, immunogenicity of the vaccine administered through aerosol delivery systems, and how pre-existing adenovirus immunity impacts immune responses after receiving Ad5-triCoV/Mac or ChAd-triCoV/Mac."

Answered by AI

What prospective hazards does Ad5-triCoV/Mac pose to individuals?

"Due to the limited amount of safety and efficacy data available for Ad5-triCoV/Mac, our Power team assigned it a score of 1."

Answered by AI

Are there any open opportunities for individuals to join this clinical research?

"Affirmative. Clinicaltrials.gov data reveals that the medical experiment, which was first published on March 1st 2022, is presently recruiting participants. 30 individuals are required to take part in this trial at a single research site."

Answered by AI

What is the maximum number of participants accepted into this research project?

"Affirmative. According to clinicaltrials.gov, this test is presently recruiting participants as of October 8th, 2022. It was initially uploaded on March 1st and expected 30 patients at one facility."

Answered by AI

Could I be included in this trial?

"This clinical trial is recruiting a cohort of 30 individuals infected with COVID-19, aged between 18 and 65. Moreover, to be eligible for the study participants must fulfill additional criteria: Women will need to take a pregnancy test and use two approved forms of contraception throughout; HIV antibody negative; Capable of understanding the protocol requirements as well as attending planned visits and completing necessary tests; Men required to utilize barrier contraception during the course of this research project.; Healthy human subjects within an age range from 18 to 65 years old., Must have completed their vaccine series with 3 doses or more at least three months prior."

Answered by AI

Who else is applying?

What site did they apply to?
McMaster University Medical Centre
What portion of applicants met pre-screening criteria?
Met criteria
~6 spots leftby Sep 2024