On Oct. 20, researchers at the Imperial College of London announced plans for the first human challenge study of COVID-19, which involves deliberately infecting volunteers with the virus that causes the disease, in order to test the effectiveness of vaccines.
Vaccines generally take a long time to produce.
Adair Richards, honorary associate professor at the University of Warwick who last May published guidelines on how to ethically conduct human challenge studies, notes that during a pandemic, the risk of delays in developing treatments should be considered alongside the risks to volunteers who are intentionally exposed to disease. The study would recruit volunteers between the ages of 18 and 30 with no previous history or symptoms of COVID-19, no underlying health conditions and no known adverse risk factors for COVID-19, such as heart disease, diabetes or obesity. The aim of the United Kingdom challenge studies will be twofold: firstly to ascertain the level of virus that causes an infection; and secondly to assess the efficacy of vaccine candidates. Forty-six potential vaccines are already in human testing, with 11 of them in late-stage trials - several are expected to report results later this year or in early 2021.
The Human Challenge Programme is a partnership between Imperial College London, the Department for Business, Energy and Industrial Strategy (BEIS), hVIVO, a leading clinical company with expertise in viral human challenge models, and the Royal Free London NHS Foundation Trust. As the prevalence of COVID-19 rises and falls in populations, it can make it hard for traditional vaccine trials to assess if vaccines work, because volunteers receiving the vaccine may not be naturally exposed to the virus. And if this vaccine trial could mean that this period of trauma for the whole world will be over sooner, I want to help. "It's important that we are getting better vaccines and learning from the science and challenge studies are going to be quite useful for that".
If approved by regulators and ethics committees, the UK's human challenge trials will be the first in the world for coronavirus.
The U.K. government ispreparing to invest $43.4 million (33.6 million pounds) in the study.
The research will be conducted at the Royal Free Hospital in London, which has a specially designed area to contain the disease. However, proponents say they can speed up vaccine development and, ultimately, save lives.
Chris Chiu, lead researcher on the upcoming challenge studies, suggests the project will move cautiously and with appropriate oversight from regulatory bodies to ensure volunteers are as safe as possible.
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.
Such studies are controversial because they raise ethical concerns.
Marcos and other young volunteers say they want to take part to help bring an end to the pandemic after seeing the havoc it has wreaked.
But scientists have warned that taking a vaccine that has not completed Phase 3 trials carries health risks. However, he does add these kinds of trials can sometimes be of limited value as they only evaluate vaccine response in the youngest, healthiest populations.