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“Human challenge” trials of possible COVID-19 vaccines, where volunteers are deliberately infected with the disease, could become a reality after a British biotech firm signed a contract with the government to create and provide strains of this virus.
Preliminary work for the trials, which aim to accelerate the process of determining the efficacy of a vaccine candidate, has been carried out by hVIVO, a unit of pharmaceutical services firm Open Orphan, hVIVO said on Friday.
This involves creating a human challenge study version that could be utilized should such trials gain ethical and safety approval from regulators.
“The model development involves the manufacture of the challenge virus and the first-in-human characterisation research for this virus,” the firm said.
Supporters of human challenge trials say they’re a fantastic way to cut short the often lengthy process of testing potential vaccines on tens of thousands of volunteers in the real world who go about normal life and are tracked to see if they contract the disease or are shielded from it.
In these tightly-controlled trials, volunteers receive a vaccine and then about a month after are deliberately infected with the disease under controlled conditions. They are subsequently isolated in a quarantine centre and monitored to determine if they get sick or if the vaccine protects them.
Critics say intentionally infecting someone with a potentially fatal disease for which there is currently no effective treatment is unethical.
Any human challenge trials conducted in Britain would have to be approved by the Medicines and Healthcare products Regulatory Agency, the health care regulator that looks into security, integrity and protocol. Any assessment would be carried out after hVIVO completes its preliminary work.
The characterisation research – the initial step towards finding the right form and dose of the virus which could be used to intentionally infect participants in prospective trials – is endorsed by Imperial College London and will be run by hVIVO at a specialist research unit at London’s Royal Free Hospital.
