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Oxford Covid-19 vaccine enters advanced human trials
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IANS | 22 May, 2020
The University of Oxford said on Friday that its researchers have begun
recruiting adults and children for advanced human trials of a Covid-19
vaccine that will involve up to 10,260 volunteers across the UK.
The
initial human trials which began in April involved more than 1,000
volunteers. The immunisations in the initial trials have been completed
and the follow-up is currently underway. The advanced study will involve
Phase 2 and Phase 3 trials.
The Phase 2 part of the study
involves expanding the age range of the people the vaccine is assessed
in to include a small number of older adults and children -- aged
between 5-12 years, 56-69 years, and those over 70 years.
For
these groups, researchers will be assessing the immune response to the
vaccine in people of different ages, to find out if there is variation
in how well the immune system responds in older people or children.
The Phase 3 of the study involves assessing how the vaccine works in a large number of people over the age of 18.
This group will assess how well the vaccine works to prevent people from becoming infected and unwell with Covid-19.
Adult
participants in both Phase 2 and Phase 3 groups will be randomised to
receive one or two doses of either the ChAdOx1 nCoV-19 vaccine or a
licenced vaccine (MenACWY) that will be used as a "control" for
comparison, the University of Oxford said.
The Oxford vaccine is
made from a virus (ChAdOx1), which is a weakened version of a common
cold virus (adenovirus) that causes infections in chimpanzees, which has
been genetically changed so that it is impossible for it to replicate
in humans.
"The clinical studies are progressing very well and we
are now initiating studies to evaluate how well the vaccine induces
immune responses in older adults, and to test whether it can provide
protection in the wider population," Andrew Pollard, head of the Oxford
Vaccine Group, said in a statement.
"We are very grateful to the
huge support of the trial volunteers in helping test whether this new
vaccine could protect humans against the pandemic coronavirus," Pollard
added.
Drugmaker AstraZeneca recently joined forces with the UK government to support the Oxford University's vaccine programme.
AstraZeneca
on Thursday said that it received support of more than $1 billion from
the US Health Departments's Biomedical Advanced Research and Development
Authority (BARDA) for the development, production and delivery of
University of Oxford's upcoming Covid-19 vaccine, starting this autumn.
To
assess whether the vaccine works to protect the volunteers from
Covid-19 in the advanced trails, statisticians in the Oxford team will
compare the number of infections in the control group to the number of
infections in the vaccinated group.
"For this purpose, it is
necessary for a small number of study participants to develop Covid-19.
How quickly we reach the numbers required will depend on the levels of
virus transmission in the community," the University of Oxford said.
"If
transmission remains high, we may get enough data in a couple of months
to see if the vaccine works, but if transmission levels drop, this
could take up to 6 months," it added.
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