Clinical trial of a SARS-CoV-2 vaccine in healthy men and women [COVID-19] [UPH]
Research type
Research Study
Full title
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
IRAS ID
279315
Contact name
Katrina Pollock
Contact email
Sponsor organisation
Imperial College London
Eudract number
2020-001646-20
ISRCTN Number
ISRCTN17072692
Duration of Study in the UK
1 years, 1 months, 31 days
Research summary
COVAC1 is a study that looks at a new vaccine against the virus (SARS-CoV-2) which causes COVID-19. There are two parts to the study. One part is to assess the safety of this vaccine, since this will be the first time that it has been used in humans. The second part is to see how well, and for how long, the vaccine activates the immune system. This trial is NOT looking at whether the vaccine is effective in terms of protecting people against infection. It is just working out how well the immune system responds. Safety will be looked at in 15 healthy young adults aged 18-45. They will be given one of three different doses (0.1, 0.3 and 1 µg) by injection into the muscle, going slowly from the lowest to the highest dose over a period of several weeks. They will be carefully checked for any reactions to the vaccine. As long as there are no safety problems, the second part of the study will start. About 100 participants aged 18-45 will be given one of three doses (0.1, 0.3 and 1 µg). Chance will determine which dose each person is given. The vaccine is given by injection into the muscle of the upper arm. Two injections, four weeks apart, are needed. Participants will be asked to record any symptoms in an online diary. In order to see how well the immune system is responding, they will give blood samples several times during the first 6 weeks; then monthly for a few months; then at 6 months and 12 months. \nAs long as there are no serious adverse events after about 6 weeks a further 200 people or more, from multiple sites, will be assessed for safety using highest vaccine dose (1 µg). This part of the study will include people up to the age of 75. An independent committee will regularly review the information on safety and look at the immune responses to see which dose of the vaccine should be tested in future trials.
REC name
North East - York Research Ethics Committee
REC reference
20/NE/0169
Date of REC Opinion
11 Jun 2020
REC opinion
Favourable Opinion