A first-in-human clinical trial to assess the safety and immunogenicity of a self-amplifying ribonucleic acid (saRNA) vaccine encoding the S glycoprotein of SARS-CoV-2, the causative agent of COVID 19
A COVID-19 vaccine trial investigating two self-amplifying RNA vaccine candidates for the first time in humans
What is this study about?
COVAC1 is a study that is looking at the use of two new types of vaccine against the virus (SARS-CoV-2) which causes COVID-19.
There are two parts to the study. The first part is to assess the safety of these vaccines, since this will be the first time that they have been used in humans. The second part is to see how well, and for how long, the vaccines activate the immune system. Activation of immune responses may provide protection.
This trial is not looking at whether or not the vaccines are effective in terms of preventing COVID-19. It is just assessing whether and how well the immune system responds.
Patient Information Sheet & Consent Form V5.0
Patient Information Sheet & Consent Form V7.0
Who is funding the study?
NIHR, UKRI and Philanthropists
When is it taking place?
June 2020 - June 2022
Where is it taking place?
At seven clinical research centres in London and the South East of England. Recruitment is currently taking place at Imperial College Clinical Research Facility.
Who is included?
Healthy HIV and hepatitis C negative adults age 18-75 at no greater risk of SARS-CoV-2 infection than the general population, using highly effective methods to avoid a pregnancy in self or partner with no history of anaphylaxis, severe allergy or exposure to immunosuppressants or an experimental COVID-19 vaccine.
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