A Trial of a Next Generation COVID-19 Vaccine Delivered by Inhaled Aerosol

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMcMaster University

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • ChAd-triCoV/Mac
  • Control

Treatment groups

350 Participants
are divided into 2 treatment groups

Sponsors and collaborators

McMaster University

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator