NCT06492564

Dose, Safety and Pathogenicity of SARS-CoV-2 (COVID-19) Omicron Virus (BA.5)

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Hvivo · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Detailed description

This is an exploratory study of an SARS-CoV-2 Omicron (BA.5) challenge strain to determine the optimum safe infectious titer of challenge agent in healthy participants 18 to 40 years of age. Up to 90 participants who meet all study inclusion and no exclusion criteria will be allocated to one of the three dose escalating cohorts (Dose 1, Dose 2 or Dose 3), with up to 30 participants in each dose group, to receive one dose of SARS-CoV-2 omicron. Based on the outcome of each cohort the next cohort may receive a high or lower dose than the previous cohort. Each participant will remain in the study for approximately 9 months from screening to the last clinic visit. The study is divided into three phases: 1. Screening phase: Screening will occur between Day -90 to Day -2/-1. 2. Quarantine phase: Participants will stay in the quarantine unit for approximately 17 days (from Day -2/-1 to Day 14). One or two days prior to the day of inoculation with the challenge virus, participants will be admitted to quarantine where their eligibility will be reassessed. If participants remain eligible for the study, they will receive the challenge virus on Day 0. Participants will undergo a range of clinical assessments and safety monitoring for the entirety of their stay in quarantine. Participants will be discharged from the quarantine unit on Day 14 (or may remain longer at the principal investigator's discretion). If participants do not become infected with the virus they may be discharged earlier on Day 8. 3. Outpatient phase:Following the conclusion of the quarantine phase, participants will receive telephone follow up calls every 3 days between quarantine discharge and the day 28 follow up visit. Participants will also attend additional Follow-Up visits, approximately 28 days, 90 days, and 180 days after they received the study virus. Their symptoms will be reassessed, and a complete safety examination performed.

Conditions

• SARS-CoV-2 Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-12-02
• Primary completion: 2025-10-16
• Completion: 2025-10-16
• First posted: 2024-07-09
• Last updated: 2025-11-21

Locations

1 site across 1 country: United Kingdom