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A Dose Finding Human Experimental Infection Study With SARS-CoV-2 Omicron BA.5 Subvariant in Healthy Volunteers Immunologically Experienced Against SARS-CoV-2
A phase 1, dose-finding open label clinical infection, safety and viral detection optimization in healthy volunteers immunologically experienced against SARS-CoV-2.
Details
| Lead sponsor | University of Oxford |
|---|---|
| Phase | Phase 1 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 45 |
| Start date | 2024-08-08 |
| Completion | 2028-10-31 |
Conditions
- SARS-CoV-2 Infection
Interventions
- Omicron BA.5 SARS-CoV-2 challenge virus
Primary outcomes
- Occurrence of solicited and unsolicited adverse events, including severe adverse events — Day 180
Safety and human clinical response to SARS-CoV-2 Omicron BA.5 subvariant intranasal challenge in participants who are immunologically experienced against SARS-CoV-2 will be measured by solicited and unsolicited adverse events, including severe adverse events, post viral challenge and other objective parameters such as vital signs, physical examination, smell test, spirometry, ECG, and clinical laboratory results. - Selection of the optimal SARS-CoV-2 dose(s) — Day 14 or until discharge criteria is met
The optimal dose is the dose required to induce laboratory confirmed upper respiratory tract infection in 50%-75% of immunologically experienced, healthy volunteers following intranasal challenge. Laboratory confirmed infection is defined as two or more quantifiable SARS-CoV-2 qRT-PCR from mid-turbinate or throat swab samples, at two consecutive time points starting from D2 post challenge and up to discharge from quarantine.
Countries
United Kingdom