A phase 2/3 study to determine the efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19

Status: Open

Type: Interventional

IRAS-Number: 281904

CPMS-ID: 45551

Description:
A new virus causing respiratory disease emerged in Wuhan, China in December 2019 and has since rapidly spread to many other countries around the world, despite unprecedented containment efforts. The virus is part of the Coronavirus family which can cause respiratory infections ranging from the common cold to more severe diseases. This virus causes the disease known as COVID-19.

Common symptoms of COVID-19 include fever, tiredness, and dry cough. Whilst about 80% of infected people have no or mild symptoms and will recover from the disease without needing special treatment, 1 in every 6 people who gets COVID-19 becomes seriously ill. Older people and those with underlying medical problems are more likely to develop serious illness. Thousands of deaths have been reported so far.

The World health Organisation declared the COVID-19 epidemic a Public Health Emergency of International Concern on 30th January 2020. There are no currently licensed vaccines or specific treatments for COVID-19.

This study will enable us to assess how well people of all ages can be protected from COVID-19 with this new vaccine called ChAdOx1 nCoV-19. It will also give us valuable information on safety aspects of the vaccine and its ability to generate good immune responses against the virus.

We will enrol small numbers of older adults (56-70 years, then 70+ years) before expanding to large numbers of adults across all ages (18+ years). After this we will also assess the vaccine in a small cohort of children (5-12 years). In total we will enrol up to 5260 volunteers.