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Human Challenge Trials Will Deliberately Infect Dozens in the UK

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Young, healthy people will be intentionally exposed to the virus responsible for COVID-19 in a first-of-its kind ‘human challenge trial’, the UK government and a company that runs such studies announced on 20 October. The experiment, set to begin in January in a London hospital if it receives final regulatory and ethical approval, aims to accelerate the development of vaccines that could end the pandemic.

Human challenge trials have a history of providing insight into diseases such as malaria and influenza. The UK trial will try to identify a suitable dose of the virus SARS-CoV-2 that could be used in future vaccine trials. But the prospect of deliberately infecting people—even those at low risk of severe disease—with SARS-CoV-2, a deadly pathogen that has few proven treatments, is uncharted medical and bioethical territory.

Proponents of COVID-19 challenge trials have argued that they can be run safely and ethically, and that their potential to quickly identify effective vaccines outweighs the low risks to participants. But others have raised questions about the safety and value of these studies, pointing out that large-scale efficacy trials involving tens of thousands of people are expected to deliver results on several COVID-19 vaccines soon.

“Deliberately infecting volunteers with a known human pathogen is never undertaken lightly. However, such studies are enormously informative about a disease,” said Peter Openshaw, an immunologist at Imperial College London and investigator on the study, in a press statement. “It is really vital that we move as fast as possible towards getting effective vaccines and other treatments for COVID-19, and challenge studies have the potential to accelerate and de-risk the development of novel drugs and vaccines.”

Dose testing

The planned COVID-19 challenge study will be led by a Dublin-based commercial clinical-research organization called Open Orphan and its subsidiary hVIVO, which runs challenge trials on respiratory pathogens. It will take place in the high-level isolation unit of the Royal Free Hospital in north London, says Open Orphan executive chair Cathal Friel.

The UK government’s COVID-19 Vaccine Taskforce has agreed to pay the company up to £10 million (US$13 million) to conduct the trial, with the possibility of contracting Open Orphan to run several more to test various vaccines. The UK Medicines and Healthcare Regulatory Agency (MHRA), which regulates clinical trials in the United Kingdom, and an ethical review committee, still need to approve the initial trial and its design, and that of future studies.

The initial trial will involve an estimated 30–50 participants, says Andrew Catchpole, a virologist and the chief scientific officer at Open Orphan who is leading the work. It is open only to healthy adults aged 18–30.

The precise design of the study has not been finalized. But it is likely that a small number of participants will receive a very low dose of a SARS-CoV-2 ‘challenge strain’ derived from a currently circulating virus and grown under stringent conditions. If none or few of the participants become infected, the researchers will seek permission from an independent safety monitoring board to expose

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To Test Virus Vaccines, U.K. Study Will Intentionally Infect Volunteers

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LONDON — Scientists at Imperial College London plan to deliberately infect volunteers with the coronavirus early next year, launching the world’s first effort to study how vaccinated people respond to being intentionally exposed to the virus and opening up a new, uncertain path to identifying an effective vaccine.

The hotly contested strategy, known as a human challenge trial, could potentially shave crucial time in the race to winnow a number of vaccine candidates. Rather than conducting the sort of trials now underway around the world, in which scientists wait for vaccinated people to encounter the virus in their homes and communities, researchers would purposely infect them in a hospital isolation unit.

Scientists have used this method for decades to test vaccines for typhoid, cholera and other diseases, even asking volunteers in the case of malaria to expose their arms to boxes full of mosquitoes to be bitten and infected. But whereas the infected could be cured of those diseases, Covid-19 has few widely used treatments and no known cure, putting the scientists in charge of Britain’s study in largely uncharted ethical territory.

Starting with tiny doses, the scientists will first administer the virus to small groups of volunteers who have not been vaccinated at all, in order to determine the lowest dose of the virus that will reliably infect them. That process, scheduled to begin in January at a hospital in north London, will be followed by tests in which volunteers are given a vaccine and then intentionally exposed to this carefully calibrated dose of the virus.

The study will be led by scientists with Imperial College London and hVivo, a company specializing in human challenge trials. It still requires approval from Britain’s drug regulation agency, but the government said on Tuesday that it would allot 34 million pounds, or $44 million, in public funding.

The first round of volunteers, up to 90 healthy adults aged 18 to 30, will have the virus dripped into their noses without having been vaccinated. If not enough participants become infected, the scientists will try to expose these early-stage volunteers to a higher dose, repeating the process until they have identified the necessary exposure level of the virus.

Only once the scientists decide on a dose, which they intend to do by late spring, will they begin the process of comparing vaccine candidates by immunizing the next group of volunteers and then exposing them to the virus.

Some vaccine candidates now undergoing trials may already have received approval by then, but researchers hope a challenge trial will add direct evidence of efficacy and help them compare the performance of different vaccines.

“Deliberately infecting volunteers with a known human pathogen is never undertaken lightly,” said Professor Peter Openshaw, an immunologist and co-investigator on the study. “However, such studies are enormously informative about a disease, even one so well studied as Covid-19.”

Many important questions about the study remain unanswered. The British government’s vaccine task force, which will select the first vaccine candidates to include in

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UK plans COVID-19 ‘challenge’ trials that deliberately infect volunteers

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LONDON (Reuters) – Britain will help to fund trials using a manufactured COVID-19 virus to deliberately infect young healthy volunteers with the hope of accelerating the development of vaccines against it.

The government said on Tuesday it will invest 33.6 million pounds ($43.5 million) in the so-called “human challenge” trials in partnership with Imperial College London, laboratory and trial services company hVIVO and the Royal Free London NHS Foundation Trust.

If approved by regulators and an ethics committee, the studies will start in January with results expected by May 2021, the government said.

Using controlled doses of virus, the aim of the research team  will initially be to discover the smallest amount of virus it takes to cause COVID-19 infection in small groups of healthy young people, aged between 18 and 30, who are  at the lowest risk of harm, the scientists leading the studies said in a briefing.

Up to 90 volunteers could be involved at the initial stages, they said, and virus to be used will be manufactured in labs at London’s Great Ormond Street Hospital.

Chris Chiu, an Imperial College scientist on the team, said the experiments would rapidly increase understanding of COVID-19 and the SARS-CoV2 virus that causes it, as well as accelerating development of potential new treatments and vaccines.

Critics of human challenge trials say deliberately infecting someone with a potentially deadly disease for which there is currently no effective treatment is unethical.

Business Secretary Alok Sharma said the trials would be carefully controlled and marked an important next step in building understanding of the virus and accelerating vaccine development.

Chiu said the plan for initial studies – which are aimed at assessing how much virus it takes to infect someone with COVID-19 – is to immediately treat volunteers with the Gilead antiviral drug remdesivir as soon as they are infected.

He said that while studies have show remdesivir has little or no effect on severe COVID-19 cases, his team has a “strong belief” that it will be an effective treatment if given in the very earliest stages of infection.

A spokeswoman for the World Health Organization said that there are “very important ethical considerations” when approaching such human challenge trials.

“What is critical is that if people are considering this, it must be overseen by an ethics committee and the volunteers must have full consent. And they must select the volunteers in order to minimise their risk,” she told reporters in Geneva.

Chiu said his team’s “number one priority is the safety of the volunteers”.

“No study is completely risk free, but (we) will be working hard to ensure we make the risks as low as we possibly can,” he said.

Britain’s hVIVO, a unit of pharmaceutical services company Open Orphan, said last week it was carrying out preliminary work for the trials.

Reporting by Kate Kelland and Paul Sandle in London, with additional reporting by Stephanie Nebehay in Geneva, Editing by Michael Holden and Angus MacSwan

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Researchers Will Infect Healthy Volunteers with COVID to Test Potential Vaccines

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The U.K. government has announced plans for a COVID-19 vaccine trial where healthy volunteers will be intentionally infected with the novel coronavirus.

The human challenge trial, led by scientists at Imperial College London, is scheduled to begin in January at a quarantine facility in London with 34 million pounds ($44 million) of funding from the British government, The New York Times and ABC News reported.

Volunteers will be vaccinated and then intentionally inhale a diluted dose of the virus while being closely monitored by scientists and doctors. The overall goal of the study is to test several vaccine candidates in a controlled environment.

Trial participants will include up to 90 healthy volunteers from 18 to 30 years old. They are including younger volunteers to minimize the risk of health complications. Once the volunteers have the virus, they will be monitored in a quarantine ward of the Royal Free Hospital. There, they will undergo daily, even hourly, tests over two to three weeks, the Washington Post reported.

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According to ABC News, Dr. Chris Chiu, from the Department of Infectious Disease at Imperial College London and lead researcher on the human challenge study, said that the human challenge trial will be able to determine within 10 weeks how effective a COVID-19 vaccine is.

The study is expected to be complete in 2021 and is still subject to ethical and regulatory approval, CNBC reported. Experts are divided on whether the study is ethical, since there is no highly effective treatment for Covid-19.

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Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, revealed last week that a coronavirus vaccine for the respiratory illness may be available next year.

“[A vaccine] will likely be [available] within the first quarter of 2021, by let’s say April of 2021,” he told CBS Evening News. “But that would be predicated on the fact that all of the vaccines that are in clinical trials have proven to be safe and effective.”

As information about the coronavirus pandemic rapidly changes, PEOPLE is committed to providing the most recent data in our coverage. Some of the information in this story may have changed after publication. For the latest on COVID-19, readers are encouraged to use online resources from CDC, WHO, and local public health departments. To help provide doctors and nurses on the front lines with life-saving medical resources, donate to Direct Relief here.

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UK Plans COVID-19 ‘Challenge’ Trials That Deliberately Infect Volunteers | Top News

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LONDON (Reuters) – Britain will help to fund trials using a manufactured COVID-19 virus to deliberately infect young healthy volunteers with the hope of accelerating the development of vaccines against it.

The government said on Tuesday it will invest 33.6 million pounds ($43.5 million) in the so-called “human challenge” trials in partnership with Imperial College London, laboratory and trial services company hVIVO and the Royal Free London NHS Foundation Trust.

If approved by regulators and an ethics committee, the studies will start in January with results expected by May 2021, the government said.

Using controlled doses of virus, the aim of the research team  will initially be to discover the smallest amount of virus it takes to cause COVID-19 infection in small groups of healthy young people, aged between 18 and 30, who are  at the lowest risk of harm, the scientists leading the studies said in a briefing.

Up to 90 volunteers could be involved at the initial stages, they said, and virus to be used will be manufactured in labs at London’s Great Ormond Street Hospital.

Chris Chiu, an Imperial College scientist on the team, said the experiments would rapidly increase understanding of COVID-19 and the SARS-CoV2 virus that causes it, as well as accelerating development of potential new treatments and vaccines.

Critics of human challenge trials say deliberately infecting someone with a potentially deadly disease for which there is currently no effective treatment is unethical.

Business Secretary Alok Sharma said the trials would be carefully controlled and marked an important next step in building understanding of the virus and accelerating vaccine development.

Chiu said the plan for initial studies – which are aimed at assessing how much virus it takes to infect someone with COVID-19 – is to immediately treat volunteers with the Gilead antiviral drug remdesivir as soon as they are infected.

He said that while studies have show remdesivir has little or no effect on severe COVID-19 cases, his team has a “strong belief” that it will be an effective treatment if given in the very earliest stages of infection.

A spokeswoman for the World Health Organization said that there are “very important ethical considerations” when approaching such human challenge trials.

“What is critical is that if people are considering this, it must be overseen by an ethics committee and the volunteers must have full consent. And they must select the volunteers in order to minimise their risk,” she told reporters in Geneva.

Chiu said his team’s “number one priority is the safety of the volunteers”.

“No study is completely risk free, but (we) will be working hard to ensure we make the risks as low as we possibly can,” he said.

Britain’s hVIVO, a unit of pharmaceutical services company Open Orphan, said last week it was carrying out preliminary work for the trials.

(Reporting by Kate Kelland and Paul Sandle in London, with additional reporting by Stephanie Nebehay in Geneva, Editing by Michael Holden and Angus MacSwan)

Copyright 2020 Thomson Reuters.

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UK to infect healthy volunteers in vaccine research trial

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LONDON (AP) — U.K. researchers are preparing to infect healthy young volunteers with the virus that causes COVID-19, becoming the first to announce plans to use the controversial technique to study the disease and potentially speed up development of a vaccine that could help end the pandemic.

This type of research, known as a human challenge study, is used infrequently because some consider the risk involved in infecting otherwise healthy individuals to be unethical. But researchers racing to combat COVID-19 say that risk is warranted because such studies have the potential to quickly identify the most effective vaccines and help control a disease that has killed more than 1.1 million people worldwide.

“Deliberately infecting volunteers with a known human pathogen is never undertaken lightly,″ said Professor Peter Openshaw, co-investigator on the study. “However, such studies are enormously informative about a disease, even one so well studied as COVID-19.”

Human challenge studies have been previously used to develop vaccines for diseases including typhoid, cholera and malaria.


Imperial College London said Tuesday that the study, involving volunteers aged 18 to 30, would be conducted in partnership with the government’s Department for Business, Energy and Industrial Strategy, the Royal Free London NHS Foundation Trust and hVIVO, a company that has experience conducting challenge studies. The government plans to invest 33.6 million pounds ($43.4 million) in the research.

Governments around the world are funding efforts to develop a vaccine in hopes of ending the pandemic that has pummeled the international economy, shutting businesses and putting millions of people out of work. Forty-six potential vaccines are already in human testing, with 11 of them in late-stage trials — several expected to report results later this year or in early 2021.

The Imperial College partnership expects to begin work in January, with results expected by May. Before any research begins, the study must be approved by ethics committees and regulators.

While one or more vaccines are likely to be approved before then, the study will still be relevant because the world may need multiple vaccines to adequately protect different groups within the population, as well as treatments for those who continue to get sick, said Dr. Michael Jacobs, a consultant in infectious diseases at the Royal Free London NHS Foundation Trust who will take part in the research.

“I don’t think many people think that what we’re doing as scientists is searching for a silver bullet,” Jacobs said. “We’re going to need a whole raft of interventions in order to control this pandemic.”

Tens of thousands of volunteers around the world have already signed up to participate in more traditional trials of COVID-19 vaccines. Critics of challenge studies question the need to expose healthy people to the virus when the disease remains widespread and vaccine development is moving quickly.

In the first phase of the U.K. challenge study, researchers will expose 90 paid volunteers to the virus using nasal drops in an effort to determine the smallest level of exposure needed to cause COVID-19. Ultimately, the

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UK to infect volunteers with coronavirus in bid to speed up vaccine development

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Researchers in the U.K. are looking for healthy volunteers who are willing to be infected with the novel coronavirus in a bid to speed up vaccination development. The approach, called a human challenge trial (HCT), is not unheard of, as similar trials take place in the U.S. each year involving the influenza virus. In fact, U.S.-based non-profit 1Day Sooner has already had over 38,000 people sign up for a potential coronavirus human challenge trial.

However, the U.K. trial is being conducted in conjunction with the government, which according to a press release posted Tuesday is prepared to put over $43 million into the study. Imperial College London, the Department for Business, Energy and Industrial Strategy, the Royal Free London NHS Foundation Trust and hVivo are all prepared to play a role in the study.

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The researchers are looking for up to 90 healthy volunteers between the ages of 18 and 30, and hope to determine the smallest level of exposure to coronavirus needed to cause the disease. According to a press release, the volunteers will be compensated for the time they spend in the study and followed for up to one year after it ends to ensure long-term well-being.

The second phase will follow the same model to study how potential coronavirus vaccines work in the body, the body’s immune response to the illness and potential treatments.

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If the trial is approved by regulators and an ethics committee, the work could begin as early as January with results expected by May.

“We are doing everything we can to fight coronavirus, including backing our best and brightest scientists and researchers in their hunt for a safe and effective vaccine,” Business Secretary Alok Sharma said in the press release. “The funding announced today for these ground-breaking but carefully controlled studies marks an important step in building on our understanding of the virus and accelerating the development of our most promising vaccines which will ultimately help in beginning our return to normal life.”

Dr. Chris Chiu, of the department of infectious disease at Imperial College London, will lead the study and said his team has been safely conducting such trials involving respiratory viruses for the last 10 years.

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“No study is completely risk-free, but the Human Challenge Programme partners will be working hard to ensure we make the risks as low as we possibly can,” he said. “The U.K.’s experience and expertise in human challenge trials as well as in wider coronavirus science will help us tackle the pandemic, benefiting people in the U.K. and worldwide.”

As of Tuesday, the Johns Hopkins University coronavirus map reported more than 744,120 confirmed cases in the U.K., and nearly 44,000 deaths.

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Covid-19 challenge trials to infect healthy volunteers in U.K.

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The United States is moving more cautiously, with leading government researchers saying human challenge trials might be too risky or unnecessary. But the British scientists say the potential payoff is massive — that accelerating vaccine development by even three months could save 100,000s of lives globally.

The British experiment is scheduled to begin in January. Volunteers will be given a laboratory-grown strain of the live virus while quarantined in a secure unit at the Royal Free Hospital in London, where they will undergo daily, even hourly, tests.

The initial phase of the study, involving 50 to 90 healthy young adults, between ages 18 and 30, will seek to determine the minimal amount of virus necessary to cause an active, measurable infection.

Later in the spring, the scientists hope to enlist more volunteers, who will be inoculated with promising vaccines and then exposed to the virus to see how well the vaccines protect them.

Andrew Catchpole, chief science officer for hVIVO, a commercial pharmaceutical company that will recruit the volunteers, manufacture the challenge strain of the virus and conduct the tests, said the human challenge study will be reviewed by a specially convened ethics committee and Britain’s Medicines and Healthcare products Regulatory Agency, its version of America’s Food and Drug Administration.

Catchpole told The Washington Post it is not yet known which vaccines may be tested. He said possible candidates include those vaccines that have proven themselves in large-scale Phase 3 trials or they may be earlier in their development but potentially more effective.

Hedging its bets, the British government has signed an agreement for 100 million doses of a vaccine being trialed by Oxford University and AstraZeneca, as well as inking deals with Pfizer, Sanofi and Valneva.

The safety data gained from large, Phase 3 trials will still be essential to show the vaccines are ready to be deployed in large populations. But the British government hopes challenge trials will help accelerate the study of vaccines in mid-stages of development.

Catchpole said the major advantage is “you get efficacy data so much sooner” than trials that rely on chance exposure. If there is not much virus circulating in a population, it could take months and tens of thousands of inoculations to prove efficacy.

Challenge experiments have a long history in biomedical research, dating back to Edward Jenner’s development of a smallpox vaccine in 1796. In the modern era, challenge trials have been used extensively to study and find treatments for influenza, malaria, typhoid, dengue fever and cholera.

Covid-19, though, is different. Without a medication to reliably “rescue” volunteers from the disease, many scientists are hesitant to infect people.

Although physicians have more treatments for hospitalized patients than they did at the beginning of the pandemic, there isn’t yet an approved drug to stop recently infected people from developing a severe case.

The challenge trial participants will be given the antiviral drug remdesivir, which President Trump took when hospitalized for covid-19 and which has been approved or authorized for temporary use

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