Testing ChAd-triCoV/Mac against a placebo for COVID-19 infection

Exclusion

• −Known allergy to vaccine components or previous receipt of any experimental adenovirus-vector vaccine by the aerosol route.
• −Persons with HIV and a detectable HIV viral load (\>20 copies/mL), self-reported or confirmed.
• −Failure to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
• −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.
• −Administration of monoclonal antibodies for treatment of COVID-19 infection within 3 months.
• −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).
• −EnrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more → in any clinical trialInterventional studyA study where participants are given something to see what happens.Read more → 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.
• −For participants in the BAL sub-study, current use of anticoagulants.
• −Women who are pregnant or breastfeeding.
• −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).