Within a few weeks, dozens of young and healthy volunteers in the UK will be deliberately exposed to the coronavirus as part of the world’s first COVID-19 human challenge test.
The project, which received ethics approval February 17 by the UK government, will study how much virus is needed to start an infection. Finally, researchers can address other questions, such as how well different vaccines work.
In human challenge trials, volunteers intentionally become infected with a pathogen in a controlled environment. Researchers can then closely study disease progression or possible treatments with a level of detail largely unavailable in traditional trials, which seek to expect participants to get the disease on their own.
The possibility of proving COVID-19 challenges has sparked controversy; some question the ethics of volunteering with a relatively young pathogen whose long-term consequences are not fully understood (SN: 27/5/20) For this test, the promise of expedited research outweighs the risks for participants, say UK regulators.
I think it could become a case where the risks are acceptable to young, healthy volunteers, says Seema Shah, a bioethicist at Northwestern University Medical School in Chicago who is not involved in the trial. People may disagree, she adds, especially with uncertainty about long-term illness.
Within a month, researchers hope to enroll up to 90 healthy volunteers aged 18 to 30 who have not received the coronavirus. People under the age of 30 are usually at a lower risk of hospitalization or death than older people, but serious illness can still occur (SN: 9/9/20)
In the isolated rooms of the hospital, volunteers will be exposed to different levels of an original variant of the coronavirus that has been circulating since March 2020. Volunteers will be monitored throughout the day, allowing researchers to determine the minimum dose of coronavirus. wanted to start the infection, Andrew Catchpole, chief scientific officer at hVIVO, a London-based pharmaceutical services clinical research organization that will help run the test, said in a press release. Imagining how much exposure leads to infection is one of the long-standing questions of the COVID-19 pandemic. Researchers can also track an immune response of volunteers during the course of the infection.
The answers to these basic research questions lay the groundwork for future studies. For example, knowing the minimum infectious dose may enable future trials, yet approved for challenges, which vaccine candidates try to test, or determine if new variants of the virus can circumvent naturally acquired immunity.
Such questions are important to answer, says Shah, but with coronavirus variants that are more contagious, and perhaps more deadly, now becoming dominant, raises the question of how much impact this trial may have (SN: 1/15/21) They may behave differently from the type used for this test, weakening the wider applicability of its results.
For example, an upcoming trial that makes face-to-face comparisons of vaccine candidates may be worthwhile, but, Shah asks, if you are doing a challenge test with a type that is ultimately no longer the dominant one, what does this tell you vaccine efficacy?
Exactly how this newly approved human challenge will work remains unclear, as details have not been made public. The researchers say they plan to publish the protocol and an explanation of the study model at some point in the future.
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