The Phase III trial will assess the safety and efficacy of the vaccine candidate, ChAdOx1 nCoV-19.
The Federal University of Sao Paulo (Unifesp) will help conduct the study, which is set to begin this month and enrol 2,000 participants. Unifesp intends to enrol 1,000 front-line Covid-19 volunteers who have not been infected.
Anvisa was quoted by Reuters as saying: “This is a randomised controlled phase III study to determine the safety, efficacy … of the non-replicating ChAdOx1 nCoV-19 vaccine.
“Initial non-clinical studies in animals and Phase I clinical studies in humans to evaluate the safety of the vaccine were carried out in England and the results demonstrated that its safety profile was acceptable.”
Upon vaccination, the surface spike protein is generated, which induces the immune system to attack SARS-CoV-2 if the virus later infects the body.
The university started enrolment of healthy volunteers for a clinical trial of the vaccine in the UK in March this year. The trial is designed to enrol up to 510 participants aged 18 to 55 years.
During the study, the vaccine candidate’s safety and ability to induce an immune response will be assessed. Results from the trial are expected next month, with plans to start late-stage trials by the middle of this year.
AstraZeneca signed an agreement with the university in April to develop and distribute the vaccine candidate.
As part of the agreement, AstraZeneca will carry out the development and global manufacturing and distribution of the Covid-19 vaccine.