COVID-19 Infection study: ChAd-triCoV/Mac
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?
an investigational inhaled vaccine being studied to prevent COVID-19 infection is designed to deliver a viral vector into the lungs to stimulate immune responses against the coronavirus
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 study aims to see if the inhaled vaccine is safe and to measure the immune response in the lungs and blood.
- Who it's for
- Adults who have received three doses of an mRNA COVID-19 vaccine and are generally healthy.
- What's involved
- Participants receive one dose of the vaccine as a mist inhaled into the lungs, then have clinic visits for check‑ups and blood tests at 2, 4 and 8 weeks, report symptoms for 24 weeks, and some will undergo a bronchoscopy to collect lung cells.
- Time commitment
- The study lasts about 24 weeks with clinic visits at weeks 2, 4, and 8, plus symptom reporting and possible bronchoscopy at week 4.
- 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
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.
- 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.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Halifax, Nova Scotia, Canada; Hamilton, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.