protocolSection identificationModule nctId: NCT06381739, orgStudyIdInfo id: M011, briefTitle: A Trial of a Next Generation COVID-19 Vaccine Delivered by Inhaled Aerosol, acronym: AeroVax, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: McMaster University, class: OTHER, collaborators name: Canadian Institutes of Health Research (CIHR), descriptionModule briefSummary: 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)., conditionsModule conditions: COVID-19 Infection, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 350, type: ESTIMATED, armsInterventionsModule interventions name: ChAd-triCoV/Mac, interventions name: Control, outcomesModule primaryOutcomes measure: Antigen specific T cell responses in blood., primaryOutcomes measure: Antigen specific T cell responses in bronchoalveolar lavage (BAL)., primaryOutcomes measure: Any grade 3, 4, or 5 adverse events that are possibly or probably related to study vaccine., secondaryOutcomes measure: Confirmed COVID infection by reverse transcriptase polymerase chain reaction (RT-PCR), secondaryOutcomes measure: 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., secondaryOutcomes measure: Neutralizing and total antibody levels in BAL and blood, secondaryOutcomes measure: Any adverse events, including grade 1 or 2 or where relationship to vaccine/placebo administration or study procedures is judged not related or unlikely., secondaryOutcomes measure: Tissue-resident memory surface marker expression airway T cells, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Health Sciences Centre, city: Hamilton, state: Ontario, zip: L8S 4K1, country: Canada, geoPoint lat: 43.25011, lon: -79.84963, hasResults: False