With input from Dr Monica Vasudev

Human Challenge study approved in the UK

1.   Britain will be the first nation in the world to conduct a COVID-19 human challenge study. The trial has been approved by the UK’s clinical trials ethics body.

2.   Researchers urge healthy young individuals to volunteer for the study. The study is expected to play a crucial role in developing effective vaccines and treatments for COVOD-19.

3.   Up to 90 volunteers, 18 - 30 years of age, will be exposed to COVID-19 under safe and controlled environment, in a bid to better understand how the virus affects people.

4.   The UK government has invested £33.6 million in this first-of-its-kind study. The study will determine the smallest amount of virus needed to cause infection, and will enable doctors have a better understanding of the infection and will also assist with the pandemic response by facilitating vaccine and treatment development.

5.    The study is set to start in the next few weeks.

6.    Initially, the version of the virus that has been circulating in the country since March 2020 and appears to be of low risk in young healthy adults will be employed. The effect of the virus will be closely assessed.

7.    Following the initial study, vaccine candidates found to be safe in clinical trials, could be given to small numbers of volunteers who will be exposed to the virus, to determine the most effective vaccines and eventually hasten their development.

8. Volunteers will be given compensation for the time they spend in the study.

9. Over decades, several human challenge studies have been safely done and have played vital roles in expediting the development of treatment for malaria, typhoid, cholera, norovirus and flu. The trials were also helpful in determining the vaccine most likely to succeed in phase 3 clinical trials that would follow.

10. Through this initial study, doctors will be able to develop a better understanding of how the immune system reacts to the virus and identify factors affecting transmission, such as how an individual infected with COVID-19 transmits infectious virus particles into the environment.

11. Ethical review of the research plan is important for conducting clinical studies and approval from the Ethics Committee is a critical milestone in the development of the COVID-19 challenge model. COVID-19 Human Challenge studies can be vital in providing data and information for development of vaccines.

12.  Data from this study will enable the challenge model to be used for vaccine efficacy testing and provide answers to several fundamental scientific questions that are not possible with traditional field trials. People can express an interest in participating in this research at https://ukcovidchallenge.com/

 [Source: https://www.gov.uk/government/news/worlds-first-coronavirus-human-challenge-study-receives-ethics-approval-in-the-uk] 

Dr KK Aggarwal

President CMAAO, HCFI and Past National President IMA