Dose, Safety and Pathogenicity of SARS-CoV-2 (COVID-19) Omicron Virus (BA.5)
NCT06492564 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2025-11-21
Summary
An Exploratory Study to Establish the Dose, Safety and Pathogenicity of a SARS-CoV-2 Omicron Challenge Strain (BA.5) in Healthy Participants 18 to 40 Years of Age
Conditions
Interventions
- BIOLOGICAL
-
SARS-CoV-2 omicron virus dose arm 1
Low dose, approximately 10\^4 TCID50/mL
- BIOLOGICAL
-
SARS-CoV-2 omicron virus dose arm 2
Medium dose, approximately 10\^5 TCID50/mL
- BIOLOGICAL
-
SARS-CoV-2 omicron virus dose arm 3
High dose, approximately 10\^6 TCID50/mL
Sponsors & Collaborators
-
Hvivo
lead INDUSTRY
Principal Investigators
-
Melissa Bevan, MBBS · hVIVO Services Ltd.
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
- 2024-12-02
- Primary Completion
- 2025-10-16
- Completion
- 2025-10-16
Countries
- United Kingdom
Study Locations
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