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A Trial of the Immunogenicity and Safety of CVXGA Intranasal COVID Vaccine in Healthy Adults

Research Question:
Does a nasal vaccine for COVID protect healthy adults?

Basic Study Information

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is responsible for coronavirus disease 2019 (COVID-19) and the current pandemic. The mortality and long-term illness resulting from the spread of the virus and the consequences for society and the economy has created an urgent need for effective vaccines. A number of vaccines are now authorized or approved for use. However, there is still a need for the development of novel vaccines which will contribute to and complement the available strategies for reducing the spread of the virus. This trial is testing an investigational vaccine called CVXGA which is given into the nose as a spray into each nostril, meaning it is needle-free. An investigational vaccine is one that is not approved by the United States Food and Drug Administration (FDA). The main purpose of the trial is to understand if (1) a single dose of CVXGA is safe in up to 400 healthy adults aged 18 to 80 years, and (2) if it can make or increase (if previously vaccinated or infected) antibodies or immune responses in your body to potentially prevent COVID infection and illness. Participants should not have received a COVID-19 vaccine dose or have had a COVID infection in the 150 days (5 months) preceding planned receipt of the CVXGA trial vaccine in this trial. All participants will receive a single dose of trial vaccine at Visit 1 (Day 1).

Location: University of Rochester
Study Reference #: STUDY00008674

Lead Researcher (Principal Investigator)

Lead Researcher:  Angela Branche

Study Contact Information

Study Coordinator: Sharon Moorehead
Phone: (585) 273-3990

Additional Study Details

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