Authors: Lucy Chard (Future Science Group)
The results of the Phase I/II trial on the Oxford coronavirus vaccine – ChAdOx1 nCoV-19 – have been published in The Lancet.
The randomized controlled trial consisting of over 1,000 healthy adult volunteers aged 18–55 years started in April 2020, with subjects receiving either the ChAdOx1 nCoV-19 vaccine or a placebo MenACWY vaccine.
The paper states that the vaccine incites a good immune response in patients and no serious adverse effects have been shown.
Both parts of the immune system was stimulated, with a T cell response apparent within 14 days of the Oxford vaccine being administered and an antibody response to neutralize the virus was induced within 28 days. The responses were strongest in those patients who had received a second booster dose of the vaccine, with neutralizing activity against coronavirus visible in 100% of patient blood samples.
“We saw the strongest immune response in the 10 participants who received two doses of the vaccine, indicating that this might be a good strategy for vaccination,” Andrew Pollard, of the Oxford Vaccine Group (University of Oxford, UK), stated.
The vaccine will continue tests in a Phase III trial to further assess its protective effects against COVID-19 in humans.
The University of Oxford is working alongside the biopharmaceutical company AstraZeneca (UK), to expedite the development, large-scale manufacture and distribution of the potential vaccine, including on a global scale. The project has received support of £84 million from the UK government to help accelerate the vaccine’s development.
“We are encouraged by the Phase I/II interim data showing AZD1222 was capable of generating a rapid antibody and T-cell response against SARS-CoV-2. While there is more work to be done, today’s data increases our confidence that the vaccine will work and allows us to continue our plans to manufacture the vaccine at scale for broad and equitable access around the world,” commented Mene Pangalos, Executive Vice President of BioPharmaceuticals Research and Development at AstraZeneca.
The partnership is part of a larger global program to facilitate the clinical trial phases of the Oxford vaccine, which includes a 30,000 patient study in the USA, a pediatric study and Phase III clinical trials in low-to-middle income countries including Brazil and South Africa.
Kate Bingham, Chair of the Vaccine Taskforce (UK Government) commented: “The UK is fortunate to have such outstanding academic innovators working alongside the highly experienced global team at AstraZeneca. This partnership is working at exceptional speed to demonstrate the safety and clinical effectiveness of the chadox vaccine in protecting people against COVID-19 infection.”
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Sources: Folegatti PM, Ewer KJ, Aley PK et al. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. The Lancet. doi:org/10.1016/S0140-6736(20)31604-4 (2020) (Epub ahead of print); www.ox.ac.uk/news/2020-07-20-new-study-reveals-oxford-coronavirus-vaccine-produces-strong-immune-response