A Trial of the Immunogenicity and Safety of CVXGA Intranasal COVID Vaccine in Healthy
Does a nasal vaccine for COVID protect healthy adults?
Basic Study Information
Purpose:Location: University of Rochester
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).
Study Reference #: STUDY00008674
Lead Researcher (Principal Investigator)
Study Contact InformationStudy Coordinator: Sharon Moorehead
Phone: (585) 273-3990
Additional Study Details
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