University of Oxford
A phase I, experimental dose finding, open label, clinical infection, safety and viral detection optimisation in previously SARS-CoV-2 infected (unvaccinated or vaccinated) or uninfected vaccinated volunteers.
Coronavirus
SARS-CoV-2 virus
PHASE1
This is a phase I dose escalation challenge study in which increasing titres of wild-type SARS-CoV-2 (1x10\^1 TCID_50, 1x10\^2TCID_50, 1x10\^3TCID_50, 1x10\^4TCID_50 and 1x10\^5TCID_50) will be administered intranasally to different groups of volunteers in order to achieve a 50% (+/-10%) attack rate as determined by quantitative live viral detection and/or qPCR detection in naso-pharyngeal secretions at two consecutive 12 hourly time points (at least 24 hours after inoculation). Dose escalation will be capped at 10\^5 TCID50 and we will proceed to dose confirmation, following DSMB safety review, even if we do not meet our target attack rate of 50% +/- 10%, to enable a larger sample size to assess the dynamic range of protection at that dose and ensure confidence in the negative infection rate at that dose. A Data Safety Monitoring Board (DSMB) will review safety and quantitative virology at each dose level and will recommend continuation based on emergent data. Rescue treatment with a single course of oral Paxlovid will commence immediately after any warning symptoms or signs of COVID-19 disease beyond mild disease. Once the optimal dose of wildtype SARS-CoV-2 has been identified for previously infected volunteers and uninfected vaccinated volunteers (dose escalation groups 1 and 3), further challenge infections in groups 2 and 4 may proceed. Volunteers will remain in isolation rooms within the clinical trials unit for a minimum of 14 days post inoculation and until demonstration of the absence of live virus in two sequential samples. All 4 groups will together enrol up to 132 volunteers. This study will be funded by the Wellcome Trust and Department of Health and Social Care (DHSC).
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 132 participants |
Masking : | NONE |
Masking Description : | This is an open-label trial, however in order to minimise volunteer adverse event reporting bias by volunteers, study participants will be kept blinded to swab results for as long as possible. |
Primary Purpose : | OTHER |
Official Title : | A Dose Finding Human Experimental Infection Study With SARS-CoV-2 in Healthy Volunteers With Immunologically Sensitised With Either Previous, SARS-CoV-2 Infection and/or Vaccination Against SARS-CoV2 |
Actual Study Start Date : | 2021-05-27 |
Estimated Primary Completion Date : | 2024-03 |
Estimated Study Completion Date : | 2024-03 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years to 30 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Oxford Clinical Research Facility (OxCRF)
Oxford, Oxon, United Kingdom, Cough solution
RECRUITING
Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxon, United Kingdom, He scooped a gin
RECRUITING
Oxford University Hospital NHS Trust
Oxford, Oxon, United Kingdom, Ksaa may