Challenging the status quo?
- Compliance Insight
- Feb 18, 2021
- 2 min read
World's First Covid-19 Human Challenge Study
The first COVID-19 human challenge study has received ethics approval this week in the U.K. and is in place to start within a month. A challenge study differs from vaccine studies in that participants are purposefully dosed with the virus being targeted rather than being given a vaccine and researchers assuming that some, if not all, will be exposed to the virus eventually. Challenge trials have been used to study cholera, typhoid, malaria, and influenza. They are typically performed when the reward outweighs the risk brought to participants who are healthy, consenting adults who have been made aware of all possible outcomes.
The COVID-19 challenge study will be open to as many as 90 volunteers who are healthy and aged 18-30 years old. They will be exposed to a strain of the virus that has been present since March 2020 based on its proven “low risk in young healthy adults.” The goal of the trial is to monitor how the virus affects people and continue to “[develop] effective COVID-19 vaccines and treatments.” This trial gives researchers an advantage of knowing exactly when a person was exposed and can gather a more accurate timeline for the virus to base potential new treatments. Two concerns have been presented at the news of this study: 1) “there is no fail-safe treatment” and 2) the study participants are not representative of the world population.
Once the initial trial is completed, a portion of the volunteers will receive vaccines proven safe in clinical trials “to help identify the most effective vaccines.” The hope is that with more safe treatments and vaccines available, the sooner this pandemic will be over.
Sources:
Comments