Study of mRNA Vaccine Formulation against COVID-19 in Healthy Adults 18 Years of Age and Older

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Study Overview

Why is the study being done?
COVID-19 is a new contagious disease that has quickly infected many people all over the world. Common symptoms usually include fever, cough, and shortness of breath, among others. The symptoms can last from several days to 2 or more weeks. Some people may have no symptoms. Older adults and people with long-term health problems, especially of the lungs and heart, are at higher risk of having complications if infected than young healthy children and adults. COVID-19 may sometimes cause severe problems such as pneumonia (lung infection) and serious trouble breathing, which can lead to a hospital stay and may possibly cause death.

There are currently several vaccines that have been shown to protect against COVID-19 that have been approved/authorized and are being given to people in many countries. However, the best protection still includes maintaining social distancing, avoiding large groups of people, and practicing good hygiene.

This study will test a SARS-CoV-2 vaccine that uses a new technology called messenger ribonucleic acid (mRNA). The mRNA carries a set of temporary instructions for a cell to make an important viral protein, called an antigen. Within the vaccine, the mRNA is surrounded by a lipid nanoparticle (LNP) which protects the mRNA from being broken down in the body before it reaches the target cell. After vaccination, the LNP encourages the human target cells to accept these instructions. Once inside the human cells, the instructions in the mRNA are 'read' by the cell to produce an amount of the viral antigen corresponding to the vaccine dose given. Antigens are substances that can trigger the body's defenses to produce antibodies that fight against the disease. People who receive a vaccine may develop antibodies. These are substances in the blood which could help protect against future infection.

The purpose of this study is to determine which SARS-CoV-2 mRNA amount is safe and produces the desired immune response and antibody level for future investigations.

Study Description

  • Participation lasts for about a year with 7 to 8 study visits
  • You will be compensated for your time
  • You cannot get COVID-19 from the vaccine

  • Study Identifier: 844768

Recruitment Status

Closed
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