A coronavirus vaccine created by the University of Oxford appears safe and induces a strong immune response within the body, the first phase of human trials have revealed.
Doses of the vaccine were given to 1,077 healthy adults aged between 18 and 55 in five UK hospitals in April and May as part of the phase one clinical trial and results, published in the 'Lancet' medical journal. The results show they induced strong antibody and T-cell immune responses for up to 56 days after they were given.T-cells are crucial for maintaining protection against the virus for years.
The findings are seen as promising, but experts feel it is too soon to know if this is enough to offer protection as larger trials get underway.
"There is still much work to be done before we can confirm if our vaccine will help manage the Covid-19 pandemic, but these early results hold promise,” said Professor Sarah Gilbert, co-author of the study.
"As well as continuing to test our vaccine in phase 3 trials, we need to learn more about the virus - for example, we still do not know how strong an immune response we need to provoke to effectively protect against SARS-CoV-2 infection. If our vaccine is effective, it is a promising option as these types of vaccine can be manufactured at large scale," she said.
Booster dose
Scientists behind the trials found the response could be even greater after a second dose.
“The Phase I/II data for our coronavirus vaccine shows that the vaccine did not lead to any unexpected reactions and had a similar safety profile to previous vaccines of this type. The immune responses observed following vaccination are in line with what previous animal studies have shown are associated with protection against the SARS-CoV-2 virus, although we must continue with our rigorous clinical trial programme to confirm this in humans,” said Professor Andrew Pollard, Chief investigator of the Oxford Vaccine Trial at Oxford University and co-author of the study.
“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,” he said.
More work to be done
The project has been bolstered by £84 million of government funding to help accelerate the vaccine's development and the University of Oxford is working with the UK-based global biopharmaceutical company AstraZeneca for the further development, large-scale manufacture and potential distribution of the Covid-19 vaccine, with plans for clinical development and production of the Oxford vaccine progressing globally.
As part of the global collaboration of this important mission, the Pune-based Serum Institute of India will produce 1 billion doses of this vaccine to make it as widely available as possible.
Human trials for the vaccine candidate in India are set to start in August. The Indian company is now applying for its licence for trials and in addition, the company will start manufacturing the vaccine in large volumes with the hope of its being rolled out by the end of the year if all goes to plan.
by Nadia Hatink