The world’s first human trial (Human Challenge Trial-HCT) in which volunteers were deliberately exposed to the coronavirus to advance research in the field of covid-19 was found to be safe for healthy young adults, the study leaders announced today.
The data support the safety of this model and could lay the groundwork for future research into new coronavirus vaccines and drugs.
Open Orphan launched the test last February in collaboration with the University of London Imperial, the British government’s vaccine strike force and hVIVO.
Scientists have been using human trials for decades to learn more about diseases such as malaria, flu, typhoid and cholera, and to develop treatments and vaccines to fight them.
In April of last year, scientists at the University of Oxford began another human trial involving the re-infection of volunteers who had previously been infected with COVID-19 – instead of exposing volunteers to the virus for the first time – in an effort to better understand immunity.
The Imperial trial exposed 36 healthy volunteers – men and women – aged 18 to 29 years to the original strain of SARS-CoV-2 virus and placed them under close monitoring in a controlled quarantine environment.
After leaving the quarantine facility they will continue to be monitored for a year.
The company announced that no serious side effects were observed and the human test model appeared to be safe and well tolerated in healthy young adults.
“People in this age group are considered to be important factors in fueling the pandemic, and this research, which is representative of mild infection, allows a detailed investigation of the factors responsible for the infection and the spread of the pandemic,” said Chris Chiu. , the lead test researcher and professor of infectious diseases at Imperial.
With the model tested, Open Orphan has announced that it will be able to conduct or sign human trials for COVID-19 in 2022, following ethical and regulatory guidelines.
The results of Imperial’s research have not yet been evaluated by peers.
The researchers found that symptoms began to develop on average about two days after exposure to the virus, Imperial reported.
The infection first appears in the throat, about five days later the infection peaks and at that stage the symptoms are focused on the nose and throat.
The scientists also found that rapid tests are a reliable indicator of whether the infectious virus is present and therefore the infected person is likely to transmit the virus.
Eighteen of the volunteers became infected, 16 of whom then developed mild symptoms reminiscent of a cold such as a stuffy nose, runny nose, sneezing and sore throat, according to Imperial.
Some felt headaches, joint pains, myalgias, fatigue and fever. No one showed any serious symptoms.
Two of the participants were excluded from the final assay after developing antibodies in the interval between the initial screening and the vaccination.
Thirteen infected volunteers reportedly suffered transient immunity and tastelessness, but after 90 days both were fully recovered in all but three volunteers. The rest continue to show improvement after three months.
No changes in the condition of the lungs or any serious side effects were observed in any of them.
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