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

NCT06381739 | Recruiting Phase 2 DMC

• 1 other identifier: M011
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

COVID-19 Infection

Outcome Measures

Primary Outcomes (3)

• Antigen specific T cell responses in blood.

  Percentage of cytokine positive T cells in the blood

  2 weeks

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

  Percentage of cytokine positive T cells in the BAL

  4 weeks

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

  Frequency, incidence and nature of adverse events

  24 weeks

Secondary Outcomes (5)

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

  24 weeks

• 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.

  4 and 8 weeks

• Neutralizing and total antibody levels in BAL and blood

  2, 4 and 8 weeks

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

  24 weeks

• Tissue-resident memory surface marker expression airway T cells

  4 weeks

Study Arms (2)

ChAd-triCoV/Mac

EXPERIMENTAL

ChAd-triCoV/Mac

Biological: ChAd-triCoV/Mac

Control

PLACEBO COMPARATOR

Placebo

Other: Control

Interventions

ChAd-triCoV/Mac BIOLOGICAL

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.

ChAd-triCoV/Mac

Control OTHER

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

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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 immune responses being measured.

You may not qualify 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.
• 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 steroids for any condition.
• 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 \[\>30 mg of prednisone equivalent daily\], or moderate or severe primary immunodeficiency syndrome).
• 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 thrombocytopenia, history of myocarditis or pericarditis).
• 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.

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

Canadian Center for Vaccinology, Dalhousie University

Halifax, Nova Scotia, B3K 6R8, Canada

RECRUITING

Health Sciences Centre

Hamilton, Ontario, L8S 4K1, Canada

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Fiona Smaill

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marilyn Swinton

CONTACT

289-244-3997; swinton@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 24, 2024
• Study Start: March 25, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 6 months following enrolment for protocol and statistical analysis plan. Individual participant data available following analysis.
• Access Criteria: Full protocol will be published; statistical analysis plan and individual participant data available on request from qualified researchers

Locations

CA (2)