microbiologist has become the first human to be injected for the human trial phase of a vaccine in the UK against the novel coronavirus being developed by a group of scientists at the University of Oxford.
Elisa Granato is the first volunteer in an initial group of 800 to be part of the ground-breaking trial, which is hoped will be the answer for immunisation against the deadly virus and help with the easing of lockdown measures in place to curb its rapid transmission.
“I’m a scientist, so I wanted to try to support the scientific process wherever I can,” Granato told the BBC as she was injected in Oxford, where the trial began this week.
“Since I don’t study viruses I felt a bit useless these days, so I felt like this is a very easy way for me to support the cause,” she said, as she was injected on her 32nd birthday on Thursday.
Granato is joined by cancer researcher Edward O’Neill as the first two candidates – one of whom has been injected with the Covid-19 vaccine being trialled and the other a control vaccine which protects against meningitis.
They will now be monitored for 48 hours to observe the impact of each. Scientists will then gradually start injecting further volunteers, healthy individuals aged between 18 and 55, in a similar half-and-half process – with none of the participants aware which vaccine they have been injected with.
“Personally I have a high degree of confidence in this vaccine,” said Sarah Gilbert, professor of vaccinology at the University of Oxford’s Jenner Institute, who is leading the research.
“Of course, we have to test it and get data from humans. We have to demonstrate it actually works and stops people getting infected with coronavirus before using the vaccine in the wider population,” she said, adding that she remains “very optimistic” about the outcome.
The team will know if the Covid-19 vaccine works by comparing the number of people who get infected with coronavirus in the months ahead from those in the trial.
Professor Andrew Pollard, director of the Oxford Vaccine Group, who is leading the trial, said: “We’re chasing the end of this current epidemic wave. If we don’t catch that, we won’t be able to tell whether the vaccine works in the next few months.
“But we do expect that there will be more cases in the future because this virus hasn’t gone away.”
The researchers started screening healthy volunteers in March for the “ChAdOx1 nCoV-19” vaccine trial in the Thames Valley Region of England. ChAdOx1 nCoV-19 is made from a virus (ChAdOx1), which is a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees, that has been genetically changed so that it is impossible for it to grow in humans.
The aim of the human trial is to assess whether healthy people can be protected from Covid-19 with this new vaccine called ChAdOx1 nCoV-19. It will also provide valuable information on safety aspects of the vaccine and its ability to generate good immune responses against the deadly virus.
By vaccinating with ChAdOx1 nCoV-19, the Oxford University team is hoping to make the body recognise and develop an immune response to the spike protein that will help stop the SARS-CoV-2 or Covid-19 virus from entering human cells and therefore prevent infection.
Vaccines made from the ChAdOx1 virus have been given to more than 320 people to date and have been shown to be safe and well tolerated, although they can cause temporary side effects, such as a temperature, headache or sore arm.
Trial participants will be given an e-diary to record any symptoms experienced for seven days after receiving the vaccine. They will also record if they feel unwell for the following three weeks.
Following vaccination, participants will attend a series of follow-up visits. During these visits, the team will check participants’ observations, take a blood sample and review the competed e-diary. These blood samples will be used to assess the immune response to the vaccine.
There is a theoretical risk that the virus could induce a serious reaction to coronavirus, but the scientists say that their data suggests the risk of the vaccine producing an enhanced disease is minimal.
The team has already developed a vaccine against Mers, another type of coronavirus, using the same approach – and that had promising results in clinical trials.
The researchers are prioritising the recruitment of local healthcare workers into the trial as they are more likely than others to be exposed to the virus. A larger trial, of about 5,000 volunteers, will start in the coming months and will have no age limit. The Oxford University team is also considering a vaccine trial in Africa, possibly in Kenya, where the rates of transmission are growing from a lower base.
The optimistic time-frame being looked at for around a million doses is by September. Deals have been done with UK and overseas manufacturers to make the vaccine at scale, should it prove effective.
The UK government has pumped in an extra 20 million pound into the University of Oxford trials and said that it is “throwing everything” at finding a vaccine against coronavirus, a crucial step to start lifting the strict social distancing lockdown measures in place to suppress the spread of the deadly virus.