The
University of Oxford and the AstraZeneca laboratory are expected to soon start
recruiting volunteers in Peru for Phase III clinical trials of their COVID-19 candidate vaccine, the academic institution headquartered in the United Kingdom has reported.
On its website, the University of Oxford stated that trial centers across the U.S. are recruiting up to 30,000 adults aged 18 years or over from diverse ethnic and geographic groups.
These volunteers must be healthy or have stable underlying medical conditions, including those living with HIV, and who are at increased risk of infection from the SARS-CoV-2 virus.
In this sense, the university reports that sites in
Peru and Chile are planned to initiate recruitment shortly.
According to the higher education institution, participants are being randomized to receive two doses of either ChAdOx1 nCoV-19 or a saline control, four weeks apart, with twice as many participants receiving the potential vaccine than the saline control.
The trial is assessing efficacy and safety of the vaccine in all participants. In addition, local and systemic reactions and immune responses will be assessed in 3,000 participants.
Clinical development of ChAdOx1 nCoV-19 is progressing globally with late-stage clinical trials ongoing in the UK, Brazil and South Africa, led by Professor Pollard of Oxford University, and trials are planned to start in Japan and Russia, led by AstraZeneca.
These trials, together with the U.S. Phase III clinical trial will enroll up to 50,000 participants globally.
Results from the late-stage trials are anticipated later this year, depending on the rate of infection within the clinical trial communities.
In July 2020, interim results from the ongoing Phase I/II COV001 trial were published in The Lancet and showed ChAdOx1 nCoV-19 was tolerated and generated robust immune responses against the SARS-CoV-2 virus in all evaluated participants.
"We are pleased that AZD1222 demonstrated safety and immunogenicity across all adult age groups and are proud to be collaborating with BARDA and NIAID to accelerate the development of this vaccine," said Mene Pangalos, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca.
"Should clinical trials demonstrate the vaccine protects against COVID-19 disease and is approved for use, we will work hard to make it globally available in a fair and equitable manner as rapidly as possible," he added.
Oxford's partner for manufacture and supply of the vaccine, AstraZeneca, continues to engage with governments, multilateral organizations and partners around the world to ensure broad and equitable access to the vaccine, should clinical trials prove successful.
Their recent supply announcements with Russia, South Korea, Japan, China, Latin America and Brazil take the global supply capacity towards three billion doses of the vaccine.
AstraZeneca Director for Andean Countries Allan Aldana has confirmed that Peru is included in the Phase III studies.
Published: 9/3/2020