The government of the United Kingdom has agreed to carry out the first coronavirus human challenge trials with a company that carries out such trials. In such trials, young and healthy people will be deliberately infected with the coronavirus, and after that, some of them will be given the coronavirus vaccine candidate. The aim of these trials is to increase the speed of the development of vaccines.
The human challenge trials, which according to the experts are controversial, essentially injects the volunteers with a disease that is infectious. The main purpose of these trials is to recruit young, healthy people and then infect them with the virus to determine the effectiveness of the vaccine. Some experts believe that these types of trials are against ethics, while its supporters believe that it can speed up the development of vaccines.
A Dublin based clinical organization named Open Orphan and one of its subsidiaries hVIVO will lead the planned coronavirus human challenge trials. Open Orphan Executive Chairperson Cathal Friel said that the trials will be done in an isolation unit of the Royal Free Hospital (North London). The Coronavirus vaccine task force of the government of the UK has agreed to a deal worth 13million dollars with the company for carrying out the trials, and there is a possibility that several more trials of these kinds will be carried out to check different vaccines. The initial trials and future studies of such kind still need to be approved by the Medicines and Healthcare Regulatory Agency (MHRA) of the UK and a review committee.
Around 30 to 50 people will be involved in the initial trials who are healthy adults aged between 18 and 30, said Andrew Catchpole who is the chief scientific officer and a virologist at Open Orphan and is leading these Coronavirus human challenged trials. The exact plan of the trials has not yet finalized. However, the probability is that few of the volunteers will be given a small dose of the strain causing coronavirus. If only a few or none of the volunteers become infected with the virus, the researchers will ask for the permission of higher doses from an independent safety monitoring board. Catchpole said that these processes will be done again and again until a dose that infects most of the volunteers is identified.
Open orphan might run several trials of this kind to test various vaccines, once the researchers are successful in identifying the suitable dose. Catchpole said that the team is yet to determine the design of the trials and to include which of the vaccines. He thinks that some of the volunteers will be given a placebo injection instead of the vaccine, however, according to him, head-to-head trials can also be done to compare two or more vaccines. Other vaccine trials carried out by the company usually enrolls around 40 to 50 volunteers.
According to Catchpole, every possible precaution will be taken by his team in the initial trials for the volunteers. They will be given remdesevir, once they are tested positive for the virus. Besides the health and age of the volunteers, they will also be tested for any underlying symptoms that will make them more vulnerable to severe illness from the coronavirus.