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

Study acronym: AeroVax
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 1 to 2 Primary completion date: Jul 2026 to Dec 2026v6 Show 1 more changeShow less
    • Primary completion date: Jul 2026 to Dec 2026
  2. Re-verified, no change to tracked fieldsv5
  3. Trial status: Not Yet Recruiting to Recruiting Start date: Jan 2025 to Mar 25, 2025 · Site details revisedv4 Show 2 more changesShow less
    • Start date: Jan 2025 to Mar 25, 2025
    • Site details revised
  4. Primary completion date: Jul 2025 to Jul 2026 Start date: Jun 2024 to Jan 2025 · Completion date: Jul 2026 to Jan 2027v3 Show 2 more changesShow less
    • Start date: Jun 2024 to Jan 2025
    • Completion date: Jul 2026 to Jan 2027
  5. Eligibility criteria expanded, about 9 words Secondary endpoints revised (5) · Study description expanded, about 2 words · Study title shortened, about 2 wordsv2 Show 3 more changesShow less
    • Secondary endpoints revised (5)
    • Study description expanded, about 2 words
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06381739
Lead Sponsor McMaster University
Collaborators: Canadian Institutes of Health Research (CIHR)
Conditions COVID-19 Infection
Enrollment 350 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov