UK to Conduct World’s First Human Challenge COVID-19 Trials—Deliberate Infection of Volunteers

UK to Conduct World’s First Human Challenge COVID-19 Trials—Deliberate Infection of Volunteers TrialsiteN

Back in October 2020, the United Kingdom government announced an investment of 33.6 million pounds ($43.5 million) in what’s known as “human challenge” clinical trials involving a partnership including Imperial College London, hVIVO (a laboratory and clinical trials services venture), and the Royal Free London NHS Foundation Trust.  As part of these clinical trials, young and healthy volunteers step up to be intentionally infected by COVID-19 in a bid to accelerate the development of safe and ever more effective vaccines. The proposed research must now pass the muster of both regulators and an ethics committee. Now reports from the U.S. and UK report these studies are set to commence starting with a trial to include 90 volunteers aged 18 to 30—these young people will be exposed to COVID-19 in a “safe and controlled environment.”

With an aim to investigate what is the smallest amount of the novel coronavirus necessary to trigger infection, the researchers seek to not only accelerate vaccine development but also to better understand how the virus impacts its human hosts.

Are Human Challenge Trials Ethical?

According to the World Health Organization (WHO) Guidance, this class of research can in fact be deemed ethics assuming they meet select criteria. With protections in place and young and healthy participants coupled with the highest quality medical services and continuous monitoring, these trials are actually acceptable, reports Imperial College of London.

Combined with an ethical framework involving comprehensive informed consent, such studies must be executed with “abundant forethought, caution and oversight.”  Moreover, the risk profile must be considered for any given individual participant as well as the group in addition to overall societal benefits and risks.

Who is the lead chief  investigator on this human challenge study?

Dr. Chris Chiu, Department of Infectious Diseases, Imperial College London

What is the goal of this study?

According to a news release from Imperial College London, the initial study goal is to help participating scientists better understand how the immune system reacts to COVID-19 while also contributing to the collective knowledge as to how to identify factors that influence how the virus is actually transmitted. For example, how a person who is infected ‘sheds’ infectious virus particles into the environment.

How many participants will be exposed to the SARS-CoV-2 virus in this initial study?

Up to 90 carefully selected, healthy adult volunteers will be exposed to the virus in a safe and controlled environment. The investigators here encourage volunteers aged 18 to 30 as they are at low risk for complications from COVID-19.

What is an end goal here?

Well, this study will lead to more information and knowledge about how COVID-19 impacts people. The researchers hope that once this initial study is completed, actual vaccine candidates proven to be safe in clinical trials could actually be given to small numbers of volunteers who are then exposed to COVID-19 helping to identify the most effective vaccines and thus accelerate their development.

What agency reviewed and authorized this study?

The Health Research Authority in the UK. They have declared that the study meets the highest ethical standards.

Why are they doing this study when there are already safe and effective vaccines approved, at least on an emergency basis?

According to Kwasi Kwarteng, Business Secretary with the UK, there are quite a ways to go to fully understand what makes a highly effective COVID-19 vaccine, noting, “While there has been very positive progress in vaccine development, we want to find the best and most effective vaccines for use over the longer term. These human challenges studies—the world’s first—will take place here in the UK and will help accelerate scientists’ knowledge of how coronavirus affects people and could eventually further the rapid development of the vaccines.”

What is the trial site location?

The Royal Free Hospital—they house secure, specialized research facilities in London designed to specifically contain the virus. The researchers from Royal Free Hospital are also working with the North Central London (NCL) Adult Critical Care Network to ensure the study will not impact on the NHS’ ability to care for patients during the pandemic. The virus characterization study requires their sign off.

Background of hVIVO

hVIVO is an industry leader in providing viral challenge studies and laboratory services supporting product development for customers developing antivirals, vaccines and respiratory therapeutics. Founded back in 1988, the company has been through at least two rounds of funding and one acquisition (buying Activiomics). Once publicly traded, the company employs about 200. The firm is now backed by private equity with UK-based Aquarius Equity Partners

Lead Research/Investigator

Dr. Chris Chiu, Department of Infectious Diseases, Imperial College London

Call to Action: This is the world’s first Human Challenge study involving COVID-19, at least that has been disclosed in the West. What are your thoughts? For those interested in learning more, check out the study’s website.