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A vaccine ChAdOx1 nCoV-19 (AZD1222) designed by researchers at the University of Oxford based on a virus (ChAdOx1) that is a weakened form of an adenovirus (Latin: Adenoviridae) that causes infections in chimpanzees, which has been genetically modified to lack the ability to replicate in humans.

Genetic material from SARS-CoV-2 has been added to the virus, which causes the production of a protein called S-glycoprotein (Spike glycoprotein (S)). This protein is normally found on the surface of the SARS-CoV-2 virus and plays an important role in the SARS-CoV-2 virus infection pathway.

When inoculated with ChAdOx1 nCoV-19, the researchers aim to make the body recognise and develop an immune response against the S-glycoprotein, thus helping to stop the SARS-CoV-2 virus from entering human cells and thereby preventing infection.

Preclinical studies of the forthcoming vaccine have been conducted by Rocky Mountain Laboratories (NIAID / NIH), who performed a rapid but thorough study confirming the good safety and efficacy profile of a single dose of ChAdOx1 nCoV-19 in an animal model of royal macaques (Latin Macaca mulatta). Additional work is currently underway in preclinical studies by research teams from Australia and the UK. Nevertheless, the results obtained have allowed the planning of a Phase 1 clinical trial.

A Phase I/II clinical trial to demonstrate the safety and efficacy of the investigational ChAdOx1 nCoV-19 vaccine in a population of 1,090 healthy English volunteers aged 18 to 55 years has commenced in April 2020 (NCT04324606). Recruitment for the clinical trial has now closed. If the results of the study prove positive, up to 10,260 participants will be recruited in the Phase II clinical trial. In addition, the participant selection criteria will be amended by extending the age ranges.

A licensing agreement between the University of Oxford and multinational biotech company AstraZeneca for the development and global distribution of the ChAdOx1 nCoV-19 vaccine, known as AZD1222, has also included an agreement in which AstraZeneca has agreed to support the establishment of a joint research centre at the University of Oxford for pandemic preparedness research.

Most recently, it has been reported that AstraZeneca has received more than $1bn from the US Biomedical Advanced Research and Development Authority (BARDA) for the development, manufacture and delivery of the AZD1222 vaccine, starting in autumn 2020. The development programme also includes a Phase III clinical trial involving 30,000 adults and children.

Material was prepared by: Andrzej Jamkowy

Source:

1. http://www.ox.ac.uk

2. Preclinical study results https://www.biorxiv.org

3. Phase I/II clinical trial https://clinicaltrials.gov/

4. https://www.astrazeneca.com/

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