Target Health Blog

New Vaccine Development

May 4, 2020

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Quiz
Source:

Aerial panorama of Oxford University.
A vaccine developed by academic scientists at the University of Oxford is moving quickly into large clinical trials, giving investors a dose of optimism amid a grim landscape.
Graphic credit: by Chensiyuan - Own work, CC BY-SA 4.0,
https://commons.wikimedia.org

The University of 1) _____ is a collegiate research university in Oxford, England, with evidence of teaching as early as 1096. This would make it the oldest university in the English-speaking world and the world's second-oldest university in continuous operation. Oxford grew rapidly from 1167 when Henry II banned English students from attending the University of Paris. After disputes between students and Oxford townsfolk in 1209, some academics fled north-east to Cambridge where they established what became the University of Cambridge. These two “ancient universities“ are frequently jointly called “Oxbridge“. The history and influence of the University of Oxford has made it one of the most prestigious universities in the world.

The current COVID-19 vaccine effort, is being run out of the British university's 2) _____ Institute, which focuses on vaccine development. The Edward Jenner Institute for Vaccine Research is an infectious disease vaccine research center, also the Jenner Institute part of the University of Oxford. The laboratory began Phase 1 trials of the experimental vaccine on April 23, and said on April 24 that it planned to vaccinate 800 volunteers over the course of a month.

In the worldwide race for a vaccine to stop the coronavirus, the laboratory sprinting fastest is at Oxford University. Most other teams have had to start with small clinical trials of a few hundred participants to demonstrate safety. But scientists at the university's Jenner Institute had a head start on a vaccine, having proved in previous trials that similar inoculations - including one last year against an earlier coronavirus - appeared to be safe. That has enabled them to leap ahead and schedule tests of their new coronavirus vaccine involving more than 6,000 people by the end of next month, hoping to show not only that it is safe but also that it is effective. The Oxford group now have stated that, the first few million doses of their vaccine could be available by September.

Scientists at the National Institutes of Health's 3) _____ Mountain Laboratory in Montana last month inoculated six rhesus macaque monkeys with single doses of the Oxford vaccine. The animals were then exposed to heavy quantities of the virus that is causing the pandemic - exposure that had consistently sickened other monkeys in the lab. But more than 28 days later all six were healthy. However, Immunity in monkeys is no guarantee that a vaccine will provide the same degree of protection for humans. A Chinese company, SinoVac, that recently started a clinical trial with 144 participants, has also said that its vaccine was effective in rhesus macaques.

More than one vaccine would be needed in any case. Some may work more effectively than others in groups like children or older people, or at different costs and dosages. Having more than one variety of vaccine in production will also help avoid bottlenecks in manufacturing. But as the first to reach such a relatively large scale, the Oxford trial, even if it fails, will provide lessons about the nature of the coronavirus and about the immune system's responses that can inform governments, donors, drug companies and other scientists hunting for a vaccine.

Ethics rules, as a general principle, forbid seeking to infect human test participants with a serious disease. Thus, the only way to prove that a vaccine works is to inoculate people in a place where the virus is spreading naturally around them. If social distancing measures or other factors continue to slow the rate of new infections in Britain, the trial might not be able to show that the vaccine makes a difference: Participants who received a placebo might not be infected any more frequently than those who have been given the vaccine.

The Jenner Institute's coronavirus efforts grew out of a so-far unsuccessful pursuit of a vaccine against malaria. Professor Adrian Hill, the Jenner Institute's director and one of five researchers involved in the vaccine effort developed a fascination with malaria and other tropical diseases as a medical student in Dublin in the early 1980s, when he visited an uncle who was a priest working in a hospital during the civil war in what is now Zimbabwe. So after training in tropical medicine and a doctorate in molecular genetics, Hill, helped build Oxford's institute into one of the largest academic centers dedicated to nonprofit vaccine research, with its own pilot manufacturing facility capable of producing a batch of up to 1,000 doses.

The Jenner Institute's effort against the coronavirus uses a technology that centers on altering the genetic code of a familiar virus. A classic vaccine uses a weakened version of a virus to trigger an immune response. But in the technology that the institute is using, a different virus is modified first to neutralize its effects and then to make it mimic the one scientists seek to stop - in this case, the virus that causes 4) _____. Injected into the body, the harmless impostor can induce the immune system to fight and kill the targeted virus, providing protection. Hill has worked with that technology for decades to try to tweak a respiratory virus found in chimpanzees to elicit a human immune response against malaria and other diseases. Over the last 20 years, the institute has conducted more than 70 clinical trials of potential vaccines against the parasite that causes malaria. None have yet yielded a successful inoculation. In 2014, however, a vaccine based on the chimp virus that Hill had tested was manufactured in a large enough scale to provide 1 million doses. That created a template for mass production of the coronavirus vaccine, should it prove effective.

A longtime colleague, professor Sarah Gilbert, 58, modified the same chimpanzee virus to make a vaccine against an earlier coronavirus, Middle East respiratory syndrome 5. (_____). After a clinical trial in Britain demonstrated its safety, another test began in December in Saudi Arabia, where outbreaks of the deadly disease are still common. Other scientists involved in the project are working with a half-dozen drug manufacturing companies across Europe and Asia to prepare to churn out billions of doses as quickly as possible if the vaccine is approved. None have been granted exclusive marketing rights, and one is the giant Serum Institute of India, the world's largest supplier of vaccines.

Donors are currently spending tens of millions of dollars to start the manufacturing process at facilities in Britain and the Netherlands even before the vaccine is proven to work. But the team has not yet reached an agreement with a North American manufacturer.

The Jenner Institute's vaccine effort is not the only one showing promise. Two U.S. companies, 6) _____ and Inovio, have started small clinical trials with technologies involving modified or otherwise manipulated genetic material. They are seeking both to demonstrate their safety and to learn more about dosing and other variables. Neither technology has ever produced a licensed drug or been manufactured at scale. A Chinese company, 7) _____, has also started clinical trials in China using a technology similar to the Oxford institute's, using a strain of the same respiratory virus that is found in humans, not chimps. But demonstrating the effectiveness of a vaccine in China may be difficult because COVID-19 infections there have plummeted.

Based on the safety data from their human trials of similar vaccines for 8) _____, MERS and malaria, though, the Oxford institute has persuaded British regulators to allow unusually accelerated trials while the epidemic still is active The institute last week began a Phase I clinical trial involving 1,100 people. Crucially, next month it will begin a combined Phase 9) _____ and Phase III trial involving another 5,000. Unlike any other vaccine project now underway, that trial is designed to prove effectiveness as well as safety.

The study would declare victory if as many as a dozen participants who are given a placebo become sick with COVID-19 compared with only one or two who receive the inoculation. If too few participants are infected in Britain, the institute is planning other trials where the coronavirus may still be spreading, possibly in 10) _____ or _____.

Source: Marketwatch.com; The New York Times; Wikipedia

ANSWERS: 1) Oxford; 2) Jenner; 3) Rocky; 4) COVID-19; 5) MERS; 6) Moderna; 7) CanSino; 8) Ebola; 9) II; 10) Africa or India

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