New research aims to help doctors and scientists to further understand how immune system reacts to Sars-CoV-2
The UK has approved a first-of-its-kind study that will expose young and healthy volunteers to Covid-19 as part of efforts to further understand the virus, the government has announced.
Due to begin in the next few weeks, the study will recruit up to 90 carefully-selected participants aged between 18 and 30 – who are at the lowest risk of complications from coronavirus – and expose them to the pathogen in a safe and controlled environment.
The researchers will initially use the coronavirus that was first introduced to the UK in March 2020, as opposed to the more transmissible variant that was detected in Kent late last year.
After exposure, the volunteers will be closely assessed by medics and scientists for 24 hours a day throughout the study.
It’s hoped the research, which has received £33.6 million in government funding, will help doctors to further understand how the immune system reacts to Sars-CoV-2, identify factors that influence how the virus is transmitted and aid the development of treatments and vaccines.
Known as a Human Challenge study, it also aims to establish the smallest amount of virus needed to cause infection.
Once the first stage of the research is completed – and depending on the outcomes – additional volunteers will then be recruited, vaccinated and exposed to the virus to help identify the most effective jabs and accelerate their development.
The Human Challenge study is being delivered by a partnership between the government’s Vaccines Taskforce, Imperial College London, the Royal Free London NHS Foundation Trust and the clinical company hVIVO.
It will be conducted at the Royal Free Hospital’s specialist and secure clinical research facilities in London, which are specifically designed to contain the virus and prevent it from being spread beyond the volunteers, who will be examined for a minimum of 14 days.
Participants will only be allowed to leave the study and return home once they are no longer deemed infectious.
The researchers are working closely with the Royal Free Hospital and the North Central London (NCL) Adult Critical Care Network to ensure the study will not affect the NHS’s ability to care for patients during the pandemic.
The study will not begin without their go-ahead, the Department for Business, Energy and Industrial Strategy (Beis) has said.
Commenting on the new study, business secretary Kwasi Kwarteng said: “While there has been very positive progress in vaccine development, we want to find the best and most effective vaccines for use over the longer term.
“These Human Challenge studies will take place here in the UK and will help accelerate scientists’ knowledge of how coronavirus affects people and could eventually further the rapid development of vaccines.”
Dr Chris Chiu, from Imperial College London and the chief investigator of the study, has called on volunteers aged between 18 and 30 to come forward and “join this research endeavour”.
“Our eventual aim is to establish which vaccines and treatments work best in beating this disease, but we need volunteers to support us in this work,” he added.
The virus being used in the research has been produced by a team at Great Ormond Street Hospital, in collaboration with virologists at Imperial College London.
These Human Challenge studies have been implemented before to accelerate the development of treatments for a number of diseases, including malaria, typhoid, cholera, norovirus and flu.
The trials have also helped researchers establish which possible vaccine is most likely to succeed in phase three clinical trials that would follow, usually involving thousands of volunteers.
The Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA) are the UK’s regulators responsible for providing ethics and regulatory approval, respectively for all human clinical trials.
Research Ethics Committees (RECs) are formed by the HRA as part of the approval process.
A specially-appointed independent REC has approved the study, and after reviewing the protocol, the MHRA concluded the virus characterisation study did not require its approval because the study does not involve an investigational medicinal product.
Source: Independent by Samuel Lovett