INDIANAPOLIS (WISH) — Time is of the essence and while dozens of clinical trials for a COVID-19 vaccine are underway, infectious disease experts are pushing for a controversial study design. The design is called a “human challenge study.”
A human challenge study is a way of speeding up the discovery process. Instead of waiting for people to become infected with the coronavirus and test a potential vaccine, study participants who have not yet been infected are able to voluntarily be infected with COVID-19.
If successful, antibodies against the virus will develop and immunity will follow.
Over 16,000 people have signed up for the study. Half will be injected with the coronavirus and the other half will be injected with a placebo. That is, if the study gets FDA approval.
Human challenge studies are controversial. Scientists have to decide the risks versus the rewards. But the method is considered ethical if done properly.
For participants to qualify, they would have to complete a medical history questionnaire, have no underlying conditions or be considered a vulnerable population.
Human challenge studies have been done before and were successful. Typhoid, malaria and flu vaccines all came as a result of a human challenge study.