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Oxford to launch human problem trial to review immune response

Oxford to launch human challenge trial to study immune response

Caroline Nicolls will receive an injection of the Moderna Covid-19 vaccine administered by Nurse Amy Nash at Madejski Stadium in Reading, west of London, on April 13, 2021.

STEVE PARSONS | AFP | Getty Images

LONDON – Oxford University researchers announced the start of a Human Challenge study on Monday to better understand what happens when people who have already contracted the coronavirus become infected for the second time.

The researchers will investigate what kind of immune response can prevent people from becoming infected with Covid-19 again and examine how the immune system reacts to the virus a second time.

Little is currently known about what happens to people who had the virus the second time they were infected.

The experiment is carried out in two phases with different participants in each phase. The first phase is slated to begin this month and the second phase is slated to begin in summer.

In medical research, Human Challenge studies are controlled studies in which participants are intentionally exposed to a pathogen or beetle to study the effects.

“Challenge studies tell us things that other studies cannot because, unlike natural infections, they are tightly controlled,” said Helen McShane, chief investigator for the study and professor of vaccinology in the Department of Pediatrics at Oxford University.

“If we re-infect these participants, we will know exactly how their immune systems responded to the first COVID infection, when exactly the second infection occurs, and how much virus they have,” said McShane.

It is hoped that the study will help improve scientists’ basic understanding of the virus and develop tests that can reliably predict whether people will be protected.

What happens in each phase?

In the first phase, up to 64 volunteers between the ages of 18 and 30 who were previously infected naturally will be re-exposed to the virus under controlled conditions.

Researchers will oversee attendees’ care while they perform CT scans of the lungs and MRI scans of the heart while isolating in a specially designed suite for at least 17 days.

All participants must be fit, healthy and have fully recovered from their initial infection with Covid to minimize the risk.

Study participants will only be released from the quarantine unit if they are no longer infected and there is a risk of the disease spreading.

A view of the City of London on a clear day.

Vuk Valcic | SOPA pictures | LightRocket via Getty Images

In the second phase of the experiment, two different areas are examined.

“First we will very carefully define the basic immune response of the volunteers before we infect them. We will then infect them with the dose of virus selected from the first study and measure how much virus we can detect after infection. We will then.” to be able to understand what kind of immune responses protect against re-infection, “said McShane.

“Second, we will measure the immune response several times after infection so we can understand what immune response is being generated by the virus,” she added.

The entire study period is 12 months, including at least eight follow-up appointments after discharge.

“This study has the potential to change our understanding by providing high-quality data on how our immune systems react to a second infection with this virus,” said Shobana Balasingam, senior research advisor on vaccines at Wellcome, a nonprofit that funded the study.

“The results could have important implications for the future management of COVID-19, influencing not only vaccine development but research into the range of effective treatments that are also badly needed,” Balasingam said.

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Roche arthritis drug reduces loss of life in hospitalized sufferers with extreme Covid, Oxford researchers say

Roche arthritis drug reduces death in hospitalized patients with severe Covid, Oxford researchers say

A pharmacist shows a box of tocilizumab, which is used to treat rheumatoid arthritis, in the pharmacy of Cambrai Hospital in France on April 28, 2020.

Pascal Rossignol | Reuters

A drug used to treat people with rheumatoid arthritis appears to reduce the risk of death in hospitalized patients with severe Covid-19, especially when combined with the steroid dexamethasone, Oxford University researchers said Thursday.

Oxford researchers found that the drug tocilizumab, an intravenous drug of A department of the Swiss drug manufacturer Roche also shortened the length of stay for patients in hospitals and reduced the need for a ventilator. The study was part of the recovery study, which has tested a number of potential treatments for Covid-19 since March.

“Previous studies of tocilizumab had shown mixed results and it was unclear which patients might benefit from the treatment,” said Peter Horby, professor at Oxford University and co-investigator for the recovery study, in a statement. “We now know that tocilizumab benefits apply to all COVID patients with low oxygen levels and significant inflammation.”

A total of 2,022 patients were randomly selected to receive tocilizumab, sold under the brand name Actemra, by intravenous infusion and compared to 2,094 patients who were randomly selected to receive standard care alone. The researchers said 82% of patients were also taking a steroid like dexamethasone, another drug that was found to reduce deaths in the sickest Covid-19 patients.

Researchers said 596 patients in the tocilizumab group died within 28 days, compared with 694 patients in the standard care group. That means that for every 25 patients treated with tocilizumab, “an extra life would be saved,” said Oxford researchers.

The drug increased the chances of being discharged from 47% to 54% within 28 days, the researchers said. The benefits have been seen in all patients, including those who need mechanical ventilators in an intensive care unit, they added. In patients who were not given a ventilator prior to the start of the study, tocilizumab reduced the chance of getting invasive mechanical ventilation or death from 38% to 33%, the researchers said.

The researchers said that using tocilizumab in combination with dexamethasone reduced mortality by about a third in patients who require oxygen and by almost half in patients who require a ventilator.

The results of the Oxford study have not yet been published in a peer-reviewed journal.

Public health officials and infectious disease experts say world leaders will need a range of drugs and vaccines to end the pandemic that, according to Johns, will infect more than 107.4 million people in just over a year and has killed at least 2.3 million people at Hopkins University.

In the US, the Food and Drug Administration has approved Gilead Sciences’ antiviral drug Remdesivir for the treatment of Covid-19 patients who are 12 years or older and require hospitalization.

The FDA has approved the use of two monoclonal antibody treatments as well as two vaccines – from Pfizer and Moderna. A third vaccine from Johnson & Johnson is expected to receive FDA approval as early as this month.

The Covid-19 Therapy Randomized Evaluation, or Recovery Study, was launched in March by researchers at Oxford University to find treatments for Covid-19. The study previously showed that hydroxychloroquine, lopinavir ritonavir, azithromycin, and convalescent plasma had no benefits for patients hospitalized with Covid-19.

The study is currently investigating aspirin, the anti-inflammatory drugs baricitinib and colchicine, and Regeneron’s antibody cocktail.

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Oxford researcher says future strains might be protected towards

Oxford researcher says future strains can be protected against

Sir John Bell, a professor at Oxford University in the UK, told CNBC on Wednesday that he was confident that Covid-19 vaccines could be upgraded to provide effective protection against future coronavirus mutations.

Bell’s comments on “Closing Bell” come as global attention is focused on a strain of the virus that is widespread in the UK and that may spread more easily than previous variants. It has since been discovered in Colorado and California.

“This is going to be a game of cat and mouse,” said Bell, who worked with AstraZeneca to oversee vaccine development at Oxford. The UK government approved emergency vaccine use on Wednesday after granting limited approval for Pfizer and BioNTech’s vaccine earlier this month.

Studies are currently underway to officially determine whether Oxford-AstraZeneca’s vaccine will protect against the new strain of the virus, Bell said. “We think they probably can, but we just want to be absolutely sure.”

“Given the level of disease in the UK with the new variant … we will have many examples of people who have had the vaccine and are exposed to the virus and we will be able to report fairly quickly on whether the vaccine actually protects against this strain,” added Bell added.

In addition to the coronavirus variant found in Great Britain, a separate strain has come into focus, which was first found in South Africa. Officials at the U.S. Centers for Disease Control and Prevention said Wednesday it may also be floating around in America.

Bell told CNBC that he believes the variant discovered in South Africa has mutations that make it “a little more worrying” than the UK’s predominant strain. Still, Bell expressed confidence in how scientists will deal with virus mutations that escape the protection of existing vaccines.

“If we need to make new vaccines, now that we’ve done the first work, we can make them. I’m sure our friends can do the same with the RNA vaccines,” said Bell. Pfizer-BioNTech and Moderna vaccines were developed using messenger RNA technology, a new approach that uses genetic material to trigger an immune response. Oxford-AstraZeneca’s viral vector vaccine uses a weakened version of a cold virus that causes infections in chimpanzees.

“We are ready if we need to make another vaccine to get closer,” added Bell. He also noted that the vaccine update development process is unlikely to require the same large-scale clinical trials conducted this year, just immunogenicity studies to ensure that an immune response is elicited.

According to Dr. It is not uncommon for viruses to mutate, Scott Gottlieb, a former Food and Drug Administration commissioner who serves on Pfizer’s Board of Directors. “Some viruses like the flu develop their surface proteins very quickly, so we need a different flu vaccine every season,” he told CNBC earlier this month.

Gottlieb said at the time that he also believed the vaccines in place will protect against the strain of virus transmitted in the UK, as the vaccines target the entire spike protein of the coronavirus.

“We are developing antibodies against many different regions of this protein. Even if part of this protein were mutated and some antibodies no longer recognized it, there would be antibodies against other parts of this protein,” he said. “That probably won’t bypass our vaccines that easily, but at some point we’ll have to update the vaccines.”

Disclosure: Scott Gottlieb is a CNBC employee and a member of the boards of directors of Pfizer, the genetic testing startup Tempus, and the biotech company Illumina. Gottlieb is also co-chair of Norwegian Cruise Line Holdings and Royal Caribbean’s Healthy Sail Panel.

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U.Okay. Authorizes Covid-19 Vaccine From Oxford and AstraZeneca

U.K. Authorizes Covid-19 Vaccine From Oxford and AstraZeneca

LONDON – The UK on Wednesday became the first country to approve the emergency coronavirus vaccine developed by AstraZeneca and Oxford University, clearing the way for a cheap and easy-to-store shot that much of the world will rely on to help the pandemic.

In a bold departure from prevailing global strategies, the UK government also decided to give as many people as possible a first dose of coronavirus vaccines rather than holding back supplies for quick second shots, significantly increasing the number of people vaccinated.

That decision has put Britain at the forefront of a far-reaching and unsafe experiment to speed up vaccination that some scientists believe will contain the suffering of a pandemic that kills hundreds of people in the UK and thousands around the world every day.

The effects of delaying the second dose to allow more people to receive partial protection from a single dose are not fully known. The UK, viewed by experts as the first country to implement such a plan, will also delay the second dose of the Pfizer BioNTech vaccine, which has been used there for several weeks and is in clinical trials after a single dose.

Some participants in the Oxford AstraZeneca vaccine clinical trial received the two doses several months apart. UK regulators said Wednesday that the first dose of the vaccine had 70 percent effectiveness against Covid-19 between the time that shot was taken and a second shot was administered, although those numbers apply to a limited subset of study participants, and so do also done have not been published.

Together, the UK’s two steps – getting the Oxford-AstraZeneca vaccine approved and extending the dose gap – provided the clearest signal yet of how countries still infected with the virus could speed up the pace of vaccination programs.

The Oxford-AstraZeneca shot is expected to be the world’s dominant form of vaccination. At $ 3 to $ 4 per dose, this is a fraction of the cost of some other vaccines. It can also be shipped and stored in regular refrigerators for six months instead of the ultra-cold freezers required for Pfizer-BioNTech and Moderna vaccines. This makes it easier to administer to people in poorer and hard-to-reach parts of the world.

“This is very good news for the world – it greatly facilitates the global approach to a global pandemic,” said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine. Regarding the decision to postpone the second dose, he said, “In a pandemic, it is better to provide some level of protection to more people than that all people who are vaccinated have full protection.”

Instead of giving the two shots of the coronavirus vaccines within a month as originally planned, clinicians in the UK will wait up to 12 weeks to give people a second dose, the government said. Matt Hancock, the health secretary, said people would get the AstraZeneca vaccine early next week.

For the UK, where hospitals are overwhelmed by cases of a new, contagious variant of the virus, the drug agency’s decision offered hope of redress. Healthcare is preparing to vaccinate almost a million people a week in makeshift locations in soccer stadiums and racetracks.

At two full-strength doses, AstraZeneca’s vaccine showed 62 percent effectiveness in clinical trials – significantly less than Pfizer and Moderna’s roughly 95 percent effectiveness. For reasons scientists don’t yet understand, AstraZeneca’s vaccine showed 90 percent effectiveness in a smaller group of volunteers given a starting dose of half strength.

UK regulators approved the vaccine in two full strength doses, saying the other regime’s more promising results were not confirmed by a full analysis. They warned that the promising results for efficacy after a single dose of the vaccine were only true in a limited number of study participants.

Updated

Dec. 30, 2020, 7:16 am ET

In the past few days, the Oxford scientists who developed the vaccine have expressed some support for delaying the second dose. Andrew Pollard, the director of the Oxford Vaccine Group, said in a radio interview Monday that it “makes a lot of sense to start with as many people as possible” by delaying the second dose.

The UK healthcare sector now needs to figure out how to get people to take a vaccine that appears less effective than other vaccines available, but which could hasten the end of the pandemic.

The approval was based on data from late-stage clinical trials in the UK and Brazil. The Indian Medicines Agency is also expected to soon decide whether to approve the vaccine, which is made there by a local vaccine manufacturer, the Serum Institute.

In the US, where the Food and Drug Administration is waiting for data from a separate clinical trial, a decision is further away. The study was canceled in September and delayed by nearly seven weeks – much longer than other countries – when regulators looked at whether a vaccine-related disease in a participant in the UK was carried out. The American regulators ultimately allowed the process.

AstraZeneca has more ambitious manufacturing goals than other vaccine manufacturers and expects to manufacture up to three billion doses over the next year. With two doses per person, this would be enough to vaccinate almost one in five people worldwide. The company has committed to offering it worldwide at cost until at least July 2021 and in poorer countries on a permanent basis.

However, the company has also been haunted by communication errors that have damaged its relationship with U.S. regulators and cast doubt on whether the vaccine will stand up to intense public and scientific scrutiny. These mistakes have shifted the vaccine timeline in the United States, where key FDA officials were baffled when they learned about the break in their clinical trials in September from the news media rather than AstraZeneca.

These setbacks have not dampened the UK craze for the country’s leading homegrown vaccine. According to analysts, this could correct the course of Prime Minister Boris Johnson’s career if introduced quickly.

The UK has made AstraZeneca the linchpin of its vaccination strategy by ordering 100 million doses, 40 million of which should be available by March. The UK has vaccinated hundreds of thousands of people since the Pfizer vaccine was approved on December 2nd. However, the country has struggled to manage it beyond hospitals and doctor’s offices, and some of its highest priority recipients, like nursing home residents, are still at risk.

“We think we’ve figured out the formula for success and figured out how to get the effectiveness that everyone else has after two doses,” Pascal Soriot, managing director of AstraZeneca, told The Times of London in an interview published on Saturday. The company has not released any evidence of efficacy rates as high as Pfizer or Moderna. “I can’t tell you more because we will eventually publish,” Soriot told the Times.

Oxford scientists published interim results from clinical trials of the vaccine in The Lancet this month. The upcoming final results of these studies are not expected to differ significantly from the interim data, as is typical in clinical research.

AstraZeneca’s US study had more than 27,000 enrolled participants last week, which was just below the target of 30,000. The study could have results and, if positive, lead to an emergency clearance in the US in February or March, Moncef Slaoui, head of Operation Warp Speed, the US federal effort to expedite coronavirus vaccines, said in a news conference last week.

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Britain Authorizes Covid-19 Vaccine From Oxford and AstraZeneca

Britain Authorizes Covid-19 Vaccine From Oxford and AstraZeneca

These setbacks have not dampened the UK craze for the country’s leading homegrown vaccine. According to analysts, this could improve Prime Minister Boris Johnson’s tenure if rolled out quickly.

The UK has made AstraZeneca the linchpin of its vaccination strategy by ordering 100 million doses, 40 million of which should be available by March. The UK has vaccinated hundreds of thousands of people since the Pfizer vaccine was approved on December 2nd. However, the country has struggled to manage it beyond hospitals and doctor’s offices, and some of its highest priority recipients, like nursing home residents, are still at risk.

A small number of volunteers in the UK clinical trial received their first dose at half strength due to a measurement problem. Oxford had hired an outside manufacturer to manufacture the vaccine for the trial. When the researchers received a sample of the vaccine, they found that its strength was twice what the manufacturer had found using a different measuring technique. Unsure of which measurement to trust, the researchers decided to cut the dose in half to make sure the volunteers didn’t get double the intended dose. The Oxford researchers later confirmed their reading was too high and switched back to the originally planned dose for the second shot.

In the smaller group of 2,741 people who received the first half-strength dose or a meningococcal vaccine as a control, the vaccine was found to be 90 percent effective. However, none of these participants were over 55 years of age, making it difficult to know if these results would apply to the elderly.

Scientists at AstraZeneca and Oxford have said they don’t know why the half-strength starting dose was so much more effective. However, they have expressed confidence in their results, particularly in finding that no one who received the vaccine in the clinical trials has developed severe Covid-19 or has been hospitalized.

“We think we’ve figured out the formula for success and figured out how to get the effectiveness that everyone else has after two doses,” Pascal Soriot, managing director of AstraZeneca, told The Times of London in an interview published on Saturday. The company has not released any evidence of efficacy rates as high as Pfizer or Moderna. “I can’t tell you more because we will eventually publish,” Soriot told the Times.

The Oxford scientists published interim results from clinical trials of the vaccine in The Lancet earlier this month. The upcoming final results of these studies are not expected to differ significantly from the interim data, as is typical in clinical research.