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New treatment option for COVID-19 Infection
Official title A Trial of a Next Generation COVID-19 Vaccine Delivered by Inhaled Aerosol
ClinicalTrials.gov ID: NCT06381739
What this study is testing
What is ChAd-triCoV/Mac?
ChAd-triCoV/Mac is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for covid-19 infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Adults who are 18-65 years old on the day of randomization (day 1)
- Able to read, write and communicate using the English or French language.
- Received at least 3 doses of an mRNA COVID vaccine.
- Individuals of childbearing potential must have a negative pregnancy test prior to vaccination and be willing to practice effective contraception for...
- Able to understand and comply with protocol requirements and instructions; able to report adverse events; able to attend scheduled study visits and...
You likely can't join if
- Failure to provide informed consent.
- Women who are pregnant or breastfeeding.
- Have received any recombinant adenoviral-vectored COVID-19 vaccine (AstraZeneca [Vaxzeria] or Johnson \& Johnson (Janssen Jcovden).
- COVID infection (positive PCR or antigen (Ag) test, self-reported or lab documented) within the last 90 days.
- Last dose of a COVID vaccine administered less than 90 days prior to study entry.
- Administration of any vaccine within 2 weeks of study entry.
See the full eligibility criteria
- Adults who are 18-65 years old on the day of randomization (day 1)
- Able to read, write and communicate using the English or French language.
- Received at least 3 doses of an mRNA COVID vaccine.
- Individuals of childbearing potential must have a negative pregnancy test prior to vaccination and be willing to practice effective contraception for 8 weeks post-vaccination.
- Able to understand and comply with protocol requirements and instructions; able to report adverse events; able to attend scheduled study visits and complete required investigations.
- For participants in the BAL sub-study, Complete Blood Count (CBC) and chemistry (creatinine) within normal limits.
- For participants in the BAL sub-study, forced expiratory volume in 1 second (FEV1) \> the lower limit of normal (LLN), and FEV1/FVC (forced expiratory volume in 1 second/forced vital capacity) ratio above the LLN.
- 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...
- Failure to provide informed consent.
- Women who are pregnant or breastfeeding.
- Have received any recombinant adenoviral-vectored COVID-19 vaccine (AstraZeneca [Vaxzeria] or Johnson \& Johnson (Janssen Jcovden).
- COVID infection (positive PCR or antigen (Ag) test, self-reported or lab documented) within the last 90 days.
- Last dose of a COVID vaccine administered less than 90 days prior to study entry.
- Administration of any vaccine within 2 weeks of study entry.
- Active pulmonary disease diagnosed by a physician including asthma, chronic bronchitis, interstitial lung disease, pulmonary hypertension, lung cancer, cystic fibrosis, or bronchiectasis. Current use of daily inhaled...
- Persons with HIV and a detectable HIV viral load (\>20 copies/mL), self-reported or confirmed.
- Administration of monoclonal antibodies for treatment of COVID-19 infection within 3 months.
- Moderately or severely immunocompromised (e.g. transplant recipients/CAR-T cell therapy, currently on chemotherapy for cancer or on potent immunosuppressant therapies e.g. rituximab or high dose steroids [\>30 mg of...
- History of severe reaction to previous COVID vaccination (e.g. hives, difficulty breathing, high fever, seizures, myocarditis, pericarditis)).
- Potential contraindication to COVID vaccination (e.g. venous or arterial thrombosis with thrombocytopenia after vaccination, history of cerebral venous thrombosis with thrombocytopenia, history of heparin induced...
- Known allergy to vaccine components or previous receipt of any experimental adenovirus-vector vaccine by the aerosol route.
- Enrolment in any clinical trial of experimental treatment for COVID infection within 90 days.
- For participants in the BAL sub-study, any health-related condition for which study bronchoscopy is contraindicated.
- For participants in the BAL sub-study, current use of anticoagulants.
The study team makes the final eligibility decision.
Where it's taking place
- Halifax, Nova Scotia, Canada
- Hamilton, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Halifax, Nova Scotia, Canada; Hamilton, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.