Sponsorship of the Human Challenge Characterisation Study

Exhibition Road
SW7 2AZ
GB

Companies House number: 04465125

£1,812,899.22

No

No

• Services Agreement - [REDACTED].pdf
• Signed contract

This contract is for research services. The benefits of the contract do not accrue exclusively to HMG but to the scientific and academic communities more widely. It is excluded from the requirements of the Public Contracts Regulations 2015 by application of regulation 14.

The contractor was identified by a selection process that concluded that Imperial was the most qualified and technically capable contractor capable of delivering the authority's requirements in the time required. The authority considered and approached a number of alternative suppliers with experience in conducting human challenge studies, clinical experience with Covid-19, and the capability to meet the responsibilities of study sponsor and provide the key roles of Chief Investigator/Principle Investigator. The organisations identified were then assessed against their capability to conduct studies within good clinical practice guidelines, their knowledge of viral challenge studies and experience with Covid-19 related studies and their network that would support the conduct of the study.

Following this evaluation, Imperial was identified as the only institution that had all of the relevant experience to act as study sponsor. Particular areas of expertise include the breadth of scientific COVID experience required to make the necessary safety decisions during the study, its involvement in a number of COVID trials and in the development the virus isolates, and its experience in running clinical trials with respect to the reporting requirements. In addition, Imperial is also the home of HICVAC, has been leading the Clinical Advisory Network and development of the study protocol. It also has senior, experienced physicians who can take on the role of Chief or Principle Investigator.

There is an urgent requirement to establish the efficacy of a number of vaccine candidates to expedite the end of the significant public health and economic consequences of the Covid-19 pandemic. The establishment of a human challenge model relating to SARS-CoV-2 is an essential element of the Vaccine Task Force's strategy for achieving this because it will allow VTF to conduct vaccine challenge studies to obtain rapid efficacy data, which will allow it to expedite its access to a portfolio of efficacious vaccines that can be administered to the UK population at large. The Sponsor role is critical to the conduct of the characterisation study and the human challenge programme could not commence without a Sponsor being appointed.