Another potential coronavirus vaccine has taken that next step to human trials this week in the UK.
Around 800 volunteers will be recruited for the study, according to a BBC report, with the first two volunteers already having been injected.
“There is an urgent need for reliable evidence on the best care for patients with COVID-19,” said Professor Peter Horby a chief investigator on the study.
“Providing possible new treatments through a well-designed clinical trial is the best way to get that evidence. Adults admitted to hospital with COVID-19 should be offered the opportunity to participate in this trial and contribute to improving care for everyone. All patients will receive the standard full medical care, regardless of which treatment group they are placed in.”
Half of the trial participants will receive the COVID-19 vaccine; the other half a control vaccine which protects against meningitis but not coronavirus.
Volunteers will not know which vaccine they are getting, but doctors will.
Elisa Granato is one of the first two to receive the jab.
“I’m a scientist, so I wanted to try to support the scientific process wherever I can,” she told the BBC.
Since January, Oxford University researchers have been working on a vaccine that targets the ‘spikes’ on the virus surface with antibodies that stick to them, so the immune system can then attack.
It has been created from adenovirus – a weakened version of a common cold virus from chimpanzees, modified so it cannot grow in humans.
The Oxford team has already developed a vaccine against a similar coronavirus, Middle East respiratory syndrome (MERS), which is a contagious, sometimes fatal respiratory illness. That vaccine already had promising results in clinical trials and this new vaccine uses the same approach.
Sarah Gilbert, professor of vaccinology at the Jenner Institute, is “very optimistic” the vaccine will work.
“Personally I have a high degree of confidence in this vaccine,” she said.
“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.”
Most vaccines targeting COVID-19 are still at the early phase one stage, including this UK-based trial.
Researcher are keen to get underway with human testing, because lockdown restrictions are rapidly closing a window of opportune conditions for testing a vaccine.
“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,” said Professor Andrew Pollard, director of the Oxford Vaccine Group, who is leading the trial.
The initial trial will comprise local healthcare workers as they are more likely than others to be exposed to the virus.
Then a larger trial of about 5000 volunteers will start in the coming months and will include people of all ages, first those aged 55-70, then those aged 70-plus.
Trials generally go through five stages, the first of which is the preclinical testing period, followed by three phases of different testing on humans before a final fourth phase, where the vaccine is monitored after rollout.
Trial groups are more likely to include high-risk groups, such as older people and target groups in the later stages of testing.
“Particularly in a pandemic or when it’s urgent, you select the high-risk group or the closest target group,” said Maximilian de Courten, a global public health expert at Victoria University’s Centre for Chronic Disease Prevention and Management, in an ABC report.
“To get the full vaccine available for everyone, that will certainly take 12 to 18 months if we are fast.
“If you want to develop an early version for the high-risk … then maybe the development is earlier.”
The trials are likely to take 12-18 months, but researchers are trying to speed up the process.
“In this pandemic, nobody wants or should wait for that,” said Prof. de Courten.
“More and more labs and groups are trying to do a parallel or staggered approach … to basically compress the timeline.”
Oxford University is already increasing production of its vaccine for later testing and a future, wider rollout, should testing be successful.
“By starting vaccine manufacturing scale-up immediately, the team can ensure that enough vaccine doses are available as soon as possible – especially for NHS (National Health Service) workers, the elderly, and those with underlying health conditions – if the trials prove that the vaccine is safe and effective,” the university said in a statement.
It is hoped that phase three testing will be underway by the end of the year.
Prof. de Courten says it’s possible to compress the timeline of normally two to three years to 12 months, “if not even less”.
But Dr Adam Stewart, from the University of Queensland’s Centre for Clinical Research, says even a 12-18 month timeline is quick for a vaccine.
“There are a lot of candidate vaccines that are showing promise out there, but certainly we shouldn’t wait and then in 18 months expect that this is all just going to be perfectly – like smallpox, it’s just going to be eradicated,” said Dr Stewart.
Human trials have so far begun in the UK, US and China. There are many vaccines in the works. The Coalition for Epidemic Preparedness Innovations (CEPI) says there were 115 potential vaccines for COVID-19 in various stages of development at the start of April.
In Australia, University of Queensland researchers have been working since January on a potential vaccine, with human trials expected between July and September.
Australia also has some human trials set to launch sooner, with phase one testing for a US company, Novavax, set to commence in Melbourne and Brisbane shortly.
Australia’s lower rate of community transmission may assist vaccine trials here, as people with no detectable exposure to COVID-19 are often what researchers want when testing vaccines.
“They’re the people you’re trying to target because, obviously, it is likely that if you’ve been exposed or even had an illness, you may have developed an immunological response,” said Dr Stewart.
Testing and trial periods would usually take much longer under normal circumstances, but the unprecedented pandemic has changed the way researchers are working towards a vaccine.
The next challenge will be to ensure that manufacturers can produce potentially billions of doses of the vaccine for the world’s population.
Prof. de Courten said while he foresees a staggered rollout, the problem of how the eventual vaccine is to be produced will have to be solved soon.
“Some of them, the influenza vaccine for instance, is produced using eggs,” he said.
“For COVID-19, there wouldn’t be enough eggs in the world.
“The production question is a very serious one. So there is one thing of finding an effective vaccine, then not being able to produce it, so you need to solve those problems.”
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