COVID-19 Omicron BA.5 Subvariant Dose Finding Infection Study
NCT06478420 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2026-04-24
Summary
A phase 1, dose-finding open label clinical infection, safety and viral detection optimization in healthy volunteers immunologically experienced against SARS-CoV-2.
Conditions
Interventions
- BIOLOGICAL
-
Omicron BA.5 SARS-CoV-2 challenge virus
The SARS-CoV-2 challenge virus strain was originally obtained from a nose/throat swab taken from a patient who developed respiratory symptoms consistent with Covid-19. All manufacturing steps are carried out in accordance with GMP by BioMARC, operating out of Colorado State University.
Sponsors & Collaborators
-
Imperial College Healthcare NHS Trust
collaborator OTHER -
Chelsea and Westminster Hospital, UK
collaborator UNKNOWN -
Royal Free London NHS Trust
collaborator UNKNOWN -
University of Oxford
lead OTHER
Principal Investigators
-
Helen McShane, MD PhD · University of Oxford
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-08-08
- Primary Completion
- 2028-10-31
- Completion
- 2028-10-31
Countries
- United Kingdom
Study Locations
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