The world’s first human challenge trial in which volunteers were deliberately exposed to Covid-19 to advance research into the disease was found to be safe in healthy young adults, one of the companies running the study said on Wednesday.
The data supports the safety of this model which could theoretically provide a “plug and play” platform for testing therapies and vaccines using the original Covid-19 strain as well as variants of the virus, Open Orphan, which carried out the study, said in a statement.
Open Orphan is running the project, launched a year ago, with Imperial College London, the UK government’s vaccines task force and the clinical company hVIVO.
The trial infected 36 healthy male and female volunteers aged 18-29 years with the original SARS-CoV-2 strain of the virus and closely monitored them in a controlled quarantined setting. They will be followed up for 12 months after discharge from the quarantine facility.
No serious adverse events occurred, and the human challenge study model was shown to be safe and well tolerated in healthy young adults, the company said.
With the model established, it said it should be able to contract or conduct Covid-19 human challenge studies in 2022, subject to individual ethics and regulatory approvals.
