Development of a Controlled Human Infection Model for Assessment of SARS-CoV-2 Omicron Subvariants

COVHIC003 is a human infection challenge study in which healthy adults aged 18-50 previously vaccinated with an approved COVID-19 vaccine will be administered a SARS-CoV-2 Omicron EG.5.1 variant given by drops in the nose. The aim is to achieve breakthrough upper-respiratory infection in a proportion of volunteers with mild or no illness, providing information on the course of Omicron infection and the immune response in vaccinated people. This study will establish an optimised challenge dose and model that can then be used to evaluate new vaccines and treatments in follow-on…

• : * The study informed consent form has been signed and dated by the participant and the Investigator * Adults age between 18 and 50 years inclusive (at the time of enrolment) * Evidence of having had at least one COVID-19 vaccine, with the last vaccination at least 3 months before enrolment * Positive serology for SARS-CoV-2 at (pre)screening * Sero-suitable as defined by having serum and/or nasal antibody titres less than a pre-defined cut-off of a defined assay(s) which will be specified in a separate SOP and based on accumulating antibody data * People of child-bearing potential (POCBP) must be willing and able to use contraception as described in the study protocol from 2 weeks before the scheduled date of viral challenge until the end discharge from quarantine. Negative urine pregnancy tests will be required at screening and on day 0 prior to inoculation. On admission to the quarantine unit a negative serum beta human chorionic gonadotropin (β-hCG) is required * Male participants who are willing to use one of the contraception methods described in the study protocol, from the time of the date of viral challenge until the end of quarantine * Agree to abstain from sexual…

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.