Background: The Oxford Vaccine Group at the University of Oxford are developing a new vaccine candidate for COVID-19, a chimpanzee adenovirus vaccine vector called AZD1222 (previously ChAdOx1). The team has previously developed a MERS vaccine.

In India, the candidate is being jointly developed by the Serum Institute of India and AstraZeneca, and goes by the name Covishield. Preclinical data in a paper on the pre-print server bioRxiv that showed a significantly reduced viral load and “humoral and cellular immune response.” The vaccine candidate also showed an immune response in mice and pigs, according to information in a pre-print paper.

Study Design: A Phase 1/2 (NCT04324606) single-blinded, multi-center study of 1,090 healthy adult volunteers aged 18-55 years with four treatment arms. Participants in two treatment arms will receive a single dose of AZD1222 or MenACWY, a meningococcal vaccine. A third treatment arm will receive AZD1222 and a booster at 4 weeks. In a fourth arm, participants will receive AZD1222 or MenACWY together with 1 g of paracetamol (acetaminophen) every 6 hours for 24 hours. The trial is active, but not currently recruiting.

Outcomes: Preliminary results from the trial published in The Lancet showed the vaccine candidate had an “acceptable safety profile” with most patients demonstrating an antibody response after one dose and all patients showing a response after two doses.

Status: On 21 May, AstraZeneca announced it has received $1 billion in funding from the Biomedical Advanced Research and Development Authority (BARDA) for “development, production and delivery of the vaccine,” beginning in September 2020. The agreement between AstraZeneca and BARDA includes a minimum of 400,000 doses of the vaccine, an upcoming Phase 3 trial of 30,000 participants, and a pediatric trial.

On 22 May, Oxford researchers announced that they had begun recruitment for a Phase 2/3 trial of approximately 10,000 healthy adult volunteers to assess how well people across a broad range of ages could be protected from COVID-19. A Phase 3 trial of AZD1222 is being funded by Operation Warp Speed. IQVIA announced they are partnering with AstraZeneca to advance clinical trials for the vaccine. Phase 2/3 trials are planned shortly in study sites in India.

Source:

https://www.ox.ac.uk/content/research-impact-oxford-launches-its-first-results-covid-19-vaccine-trial?innerWidth=90%25&innerHeight=90%25