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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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6 May 2024 |
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Main ID: |
NCT06381739 |
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Date of registration:
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23/04/2024 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Trial of a Next Generation COVID-19 Vaccine Delivered by Inhaled Aerosol
AeroVax |
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Scientific title:
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A Phase 2 Trial to Evaluate Safety and Immunogenicity of a Next-generation COVID-19 Vaccine Delivered by Inhaled Aerosol to Humans |
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Date of first enrolment:
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June 2024 |
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Target sample size:
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350 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT06381739 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Contacts
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Name:
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Fiona Smaill |
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Address:
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Telephone:
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Email:
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Affiliation:
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McMaster University |
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Name:
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Marilyn Swinton |
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Address:
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Telephone:
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289-244-3997 |
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Email:
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swinton@mcmaster.ca |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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COVID-19 Infection
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Intervention(s)
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Other: Control
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Biological: ChAd-triCoV/Mac
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Primary Outcome(s)
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Antigen specific T cell responses in blood.
[Time Frame: 2 weeks]
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Antigen specific T cell responses in bronchoalveolar lavage (BAL).
[Time Frame: 4 weeks]
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Any grade 3, 4, or 5 adverse events that are possibly or probably related to study vaccine.
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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Any adverse events, including grade 1 or 2 or where relationship to vaccine/placebo administration or study procedures is judged not related or unlikely.
[Time Frame: 24 weeks]
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Tissue-resident memory surface marker expression airway T cells
[Time Frame: 4 weeks]
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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.
[Time Frame: 4 and 8 weeks]
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Neutralizing and total antibody levels in BAL and blood
[Time Frame: 2, 4 and 8 weeks]
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Confirmed COVID infection by reverse transcriptase polymerase chain reaction (RT-PCR)
[Time Frame: 24 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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