Health TrialsbyHealthPanel

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

ConditionCOVID-19 Infection
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • ChAd-triCoV/Mac

    Biological/Vaccine

    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.

  • Control

    Other intervention

    A single dose of placebo (0.5mL formulated buffer) will be aerosolized and inhaled as the intervention vaccine.

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: ChAd-triCoV/MacExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Antigen specific T cell responses in blood.

Percentage of cytokine positive T cells in the blood

Time frame
2 weeks
2

Antigen specific T cell responses in bronchoalveolar lavage (BAL).

Percentage of cytokine positive T cells in the BAL

Time frame
4 weeks
3

Any grade 3, 4, or 5 adverse events that are possibly or probably related to study vaccine.

Frequency, incidence and nature of adverse events

Time frame
24 weeks

Secondary outcomes

1

Confirmed COVID infection by reverse transcriptase polymerase chain reaction (RT-PCR)

Positive RT-PCR test

Time frame
24 weeks
2

CD4 and CD8 T cell responses specific for the spike (S1), nucleoprotein (N) and polymerase (POL) SARS-CoV-2 antigens expressed by the vaccine, including those expressing memory T cell markers, in the peripheral blood.

Percentage of cytokine positive T cells in the blood to specific antigens

Time frame
4 and 8 weeks
3

Neutralizing and total antibody levels in BAL and blood

Anti-receptor binding domain (RBD) IgG and IgA endpoint titre; percent neutralization (surrogate virus neutralization test \[sVNT\])

Time frame
2, 4 and 8 weeks
4

Any adverse events, including grade 1 or 2 or where relationship to vaccine/placebo administration or study procedures is judged not related or unlikely.

Frequency, incidence and nature of any adverse events

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

McMaster University

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Source ClinicalTrials.gov
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