At a glance
ClinicalIndex Comparison Record- ✓Adults aged 18-65 years
- ✓Received at least 3 doses of mRNA COVID vaccine
- ✓Able to read, write and communicate in English or French
- ✓Able to understand and comply with protocol requirements and report adverse events
- ✕Failure to provide informed consent
- ✕Pregnant or breastfeeding women
- ✕Prior recombinant adenoviral-vectored COVID-19 vaccine (AstraZeneca or Johnson & Johnson)
- ✕COVID infection within last 90 days (PCR/antigen positive)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Trial to Evaluate Safety and Immunogenicity of a Next-generation COVID-19 Vaccine Delivered by Inhaled Aerosol to Humans
In Brief
A Phase 2 clinical trial evaluating ChAd-triCoV/Mac and Control for COVID-19 Infection. Currently recruiting, targeting 350 participants across 2 sites.
Detailed Summary
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). To be in the study participants will have to have already had three doses of a messenger ribonucleic acid (mRNA) COVID vaccine and be generally healthy. Participants are given a single dose of the vaccine by breathing in a fine mist that goes directly into the lungs. During follow-up participants will: * visit the clinic for checkups and blood tests at 2, 4 and 8 weeks after vaccination * report their symptoms for 24 weeks after getting the vaccine. In some participants, the researchers will collect cells from the lung 4 weeks after vaccination (a test known as a bronchoscopy).
Study Details
Timeline
Interventions
Clinical-grade, fully certified ChAd-triCoV/Mac produced according to current Good Manufacturing Principles (cGMP) will be provided. A single dose of ChAd-triCoV/Mac diluted in 0.5mL formulated buffer will be aerosolized and inhaled via a mouthpiece and tidal breathing over approximately 2 minutes using the AeroNeb Solo Mesh Nebulizer.
A single dose of placebo (0.5mL formulated buffer) will be aerosolized and inhaled as the intervention vaccine.