British Researcher Exploring COVID-19 Human Challenge Research | Imperial News

Researchers are ready to explore human challenges with the virus that causes COVID-19. This is the first such study in the world.

The Human Challenge Program is a partnership with Imperial College London, Department for Business, Energy and Industry Strategy (BEIS). hVIVO, A leading clinical company with expertise in viral human challenge models, and Royalty Free London NHS Foundation Trust..

Researchers hope that this study will ultimately help reduce the spread of the coronavirus, reduce its effects, and reduce COVID-19 mortality.

The first stage of the project explores the potential exposure of healthy volunteers to the SARS-CoV-2 coronavirus. This study enrolled volunteers aged 18-30 years with no history or symptoms of COVID-19, no underlying health status, and no known harmful risk factors for COVID-19 such as heart disease, diabetes, and obesity. We are recruiting.

UK experience and expertise in the Human Challenge Trial and the broader COVID-19 science will help us tackle the pandemic and benefit people in the UK and around the world. Dr. Chris Chiu Imperial College London

The purpose of this early stage is to find the minimum amount of virus that a person needs to develop COVID-19. This is known as a virus characterization study.

Once this first phase is complete, clinical researchers will use this human-challenge model to study how vaccines stop or prevent COVID-19 in the body, explore potential treatments, and study immune responses. I am aiming to do it.

Human Challenge studies help clinical researchers establish which vaccines are most likely to succeed. As the prevalence of COVID-19 increases and decreases in the population, vaccinated volunteers may not be naturally exposed to the virus, making it difficult to assess whether the vaccine works in traditional vaccine trials. There is a possibility. Human Challenge studies intentionally infect volunteers, so by testing whether vaccinated people are less likely to get the virus, scientists can begin to establish efficacy very quickly. You should be able to.

Human Challenge studies can also compare the effectiveness of vaccine candidates by having scientists test the vaccine candidates side-by-side to see which one is more effective. At this early stage, no specific vaccine candidates for the Human Challenge trial have been identified.

First step

First, researchers assess the amount of virus needed to cause an infection and elicit an immune response by slowly increasing the dose of virus to which a small group of volunteers are exposed. To better understand the course of the infection, the percentage of participants infected and the amount of virus released thereafter are tracked.

These groundbreaking but carefully managed studies show important next steps to build on an understanding of the virus … and ultimately help to begin a return to normal life. Masu Alok Sharma UK Business Secretary

Higher virus doses may be associated with more serious consequences, so researchers should infect volunteers at the lowest possible doses to induce virus replication but minimize symptoms. I am aiming for.

Before leaving a residential clinical facility, volunteers should be tested negative for the presence of SARS-CoV-2 in two separate laboratory tests that are very sensitive to the presence of the virus.

Dr. Chris Chiu, Department of Infectious Diseases, Imperial College London, is a Principal Investigator in Human Challenge Research, saying: 19 treatments and vaccines.

“Our top priority is volunteer safety. My team has been safely conducting human challenge studies with other respiratory viruses for over a decade. No studies are completely risk-free. However, Human Challenge Program partners strive to minimize risk.

“UK’s experience and expertise in the Human Challenge Trial and the broader COVID-19 science will help us tackle the pandemic and benefit people in the UK and around the world.”

Human Challenge studies were reviewed by a specially convened ethics committee prior to volunteer enrollment, and the Medicines and Healthcare Products Regulatory Agency (MHRA), a global example of drug and device regulation, conducted studies prior to implementation. You will be asked for approval. ..

Virus insights

Since the onset of the pandemic, doctors have learned a lot about how the SARS-CoV-2 virus spreads and which groups are at high risk, reducing the severity of the disease and its severity. Gain clinical insight into treatments. complications.

However, despite these advances, there are few treatments to treat patients with COVID-19 and no effective vaccine. Human challenge research can be an important factor in advancing research into the treatment and prevention of illness.

Professor Peter Openshaw, research collaborator and MRC-funded director Human Challenge Consortium (HIC-Vac) At Imperial College London, he said: “Intentionally infecting volunteers with known human pathogens is never lightly done, but such studies, even those that are well-studied like COVID-19, are very much about the disease. It is beneficial to.

“It is very important to act as quickly as possible to obtain effective vaccines and other treatments for COVID-19. Challenge studies accelerate the development of new drugs and vaccines and reduce risk. It is possible. These studies form part of a global effort and demonstrate our unique strengths in the Imperial and UK. “

Secretary-General Alok Sharma said:

“The funding announced today for these groundbreaking but carefully managed studies builds on the understanding of the virus and ultimately initiates our return to normal life. Here are some important next steps to accelerate the development of the most promising vaccines that will help. “

The study is scheduled to begin early next year, and volunteer recruitment and study design details will be announced in the coming months.

Future COVID-19 Human Challenge Research Anyone interested in registering interest in research should visit www.UKCovidChallenge.com