COVID-19 Clinical Trial
Official title:
A Phase 2 Trial of the Immunogenicity and Safety of CVXGA Intranasal COVID Vaccine in Healthy Adults
The purpose of this trial is to evaluate immunogenicity and safety of CVXGA administered as a single intranasal dose against SARS-CoV-2 S-protein in participants. The trial will enroll up to 400 healthy participants, age 18-80 years.
This is a randomized, placebo controlled, blinded study to evaluate the immunogenicity and safety of CVXGA. Trial Population: Up to 400 healthy adults (18-80 years) that may have had prior COVID vaccination or COVID infection at least 5 months prior to planned study vaccine receipt. Vaccine: CVXGA is a recombinant parainfluenza virus type 5 (PIV5) that carries the SARS-CoV-2 S protein. The vaccine will be administered as a single intranasal dose as a spray. Study visits: Participants will be asked to complete 3 clinic visits and 1 follow-up phone call. Participants >= 65 yrs of age will have an additional 2 clinic visits to test for vaccine shedding. Follow-up will be for 6 months after single vaccination. ;
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