COV-CHIM01: SARS-CoV-2 dose finding infection study_v1.0
A dose finding human experimental infection study with SARS-CoV-2 in healthy volunteers with previous, microbiologically confirmed, SARS-CoV-2 infection.
University of Oxford /Clinical Trials and Research Governance
Duration of Study in the UK
1 years, 6 months, 1 days
The purpose of this study is to evaluate the safety and human clinical response to SARS-CoV-2 challenge in previously SARS-CoV-2 infected people. We start by establishing the optimal challenge dose that causes re-infection. The study hopes to identify the lowest level of infectious dose necessary to produce viral replication in the upper respiratory tract of research volunteers while minimising risk of disease progression. Investigators aim to achieve an infection model which results in no symptoms, or symptoms no more severe than the common mild response of healthy people of the same age within the general population.
It is hoped that this study will enable us to determine whether immune responses to previous infection are protective and to define the levels of pre-existing immunity required for protection. If successful, this could help inform policy makers on issues, such as determining whether to allow return to unfettered travel and normal daily activities, as well as information to determine the need and timing of vaccination and re-vaccination in the context of previous infection. We aim to compare baseline and subsequent levels of humoral and cellular immunity in individuals who aren’t successfully re-infected, asymptomatically infected and (mild) symptomatic infection to identify correlates of protection. We hope to define viral shedding in the breath in both asymptomatic and mildly symptomatic patients, better informing Public Health infection control policy. Furthermore, with the recent identification of new variants that escape targeted treatments such as monoclonal antibody therapy and convalescent plasma, establishing a safe SARS-CoV-2 CHIM using wildtype virus could pave the way for future studies using variants. This could be an essential step in speeding the development pipeline of novel vaccines and therapeutics against new variants.
Specialist Adhoc REC
Date of REC Opinion
13 Apr 2021
Further Information Favourable Opinion