Next generation inhaled COVID-19 vaccine

A Phase 2 Trial to Evaluate Safety and Immunogenicity of a Next-generation COVID-19 Vaccine Delivered by Inhaled Aerosol to Humans

This study is testing a new inhaled COVID-19 vaccine to see if it is safe and can boost the immune response in people who have already had at least three doses of an mRNA COVID vaccine.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 350 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: McMaster University (Academic / other)
• Drugs / interventions: rituximab, CAR-T, chemotherapy, prednisone
• Locations: 2 sites (Halifax, Nova Scotia and 1 other locations)
• Trial ID: NCT06381739 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and immune response of a new inhaled vaccine designed to prevent COVID-19 infection. Participants, who must have received at least three doses of an mRNA COVID vaccine, will be randomly assigned to receive either the experimental vaccine or a placebo. The vaccine is administered as a fine mist inhaled directly into the lungs, and participants will undergo follow-up visits for checkups and blood tests over a 24-week period. Additionally, some participants may have lung cells collected for analysis through a bronchoscopy.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18-65 who have received at least three doses of an mRNA COVID vaccine.

Not a fit: Patients who have not received the required mRNA vaccinations or those with significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this inhaled vaccine could enhance mucosal immunity in the lungs, potentially reducing COVID-19 infections and breakthrough cases.

How similar studies have performed: Previous studies using similar aerosol delivery methods for vaccines have shown promise, indicating potential for success in this approach.

Eligibility criteria

Inclusion criteria:

1. Adults who are 18-65 years old on the day of randomization (day 1)
2. Able to read, write and communicate using the English or French language.
3. Received at least 3 doses of an mRNA COVID vaccine.
4. 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.
5. 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.
6. For participants in the BAL sub-study, Complete Blood Count (CBC) and chemistry (creatinine) within normal limits.
7. 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.
8. 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.

Exclusion criteria:

1. Failure to provide informed consent.
2. Women who are pregnant or breastfeeding.
3. Have received any recombinant adenoviral-vectored COVID-19 vaccine (AstraZeneca \[Vaxzeria\] or Johnson \& Johnson (Janssen Jcovden).
4. COVID infection (positive PCR or antigen (Ag) test, self-reported or lab documented) within the last 90 days.
5. Last dose of a COVID vaccine administered less than 90 days prior to study entry.
6. Administration of any vaccine within 2 weeks of study entry.
7. 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.
8. Persons with HIV and a detectable HIV viral load (\>20 copies/mL), self-reported or confirmed.
9. Administration of monoclonal antibodies for treatment of COVID-19 infection within 3 months.
10. 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).
11. History of severe reaction to previous COVID vaccination (e.g. hives, difficulty breathing, high fever, seizures, myocarditis, pericarditis)).
12. 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).
13. Known allergy to vaccine components or previous receipt of any experimental adenovirus-vector vaccine by the aerosol route.
14. Enrolment in any clinical trial of experimental treatment for COVID infection within 90 days.
15. For participants in the BAL sub-study, any health-related condition for which study bronchoscopy is contraindicated.
16. For participants in the BAL sub-study, current use of anticoagulants.

Where this trial is running

Halifax, Nova Scotia and 1 other locations

• Canadian Center for Vaccinology, Dalhousie University — Halifax, Nova Scotia, Canada (Recruiting)
• Health Sciences Centre — Hamilton, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Fiona Smaill — McMaster University
• Study coordinator: Marilyn Swinton

Conditions COVID-19 Infection