Dose, safety and pathogenicity of SARS-CoV-2 omicron virus (BA.5)

• Research type

  Research Study

• Full title

  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 30 Years of Age

• IRAS ID

  338100

• Contact name

  Melissa Bevan

• Contact email

  m.bevan@hvivo.com

• Sponsor organisation

  hVIVO Services Ltd.

• Duration of Study in the UK

  1 years, 1 months, 0 days

• Research summary

  This study will recruit healthy male and female participants aged 18-30 years inclusive. Approximately 90 participants who meet all study inclusion and no exclusion criteria will be allocated to one of the three dose escalating cohorts, with 30 participants in each dose group, to receive one dose of SARS-CoV-2 omicron. If de-escalation or further escalation of the inoculum dose is required, lower or higher doses than those mentioned below may be tested.
  - Dose 1: Approximately 103 tissue culture infective dose 50% (TCID50)
  - Optional Dose 2: Approximately 104 TCID50
  - Optional Dose 3: Approximately 105 TCID50

  Participants are expected to be in the study for approximately 9 months from Screening through to their last clinic visit.

  The study will consist of 3 stages:
  1. Screening: Screening will occur between Day -90 to Day -2/-1. Historical generic screening data collected through the hVIVO generic screening process may be transferred to this study after the study-specific consent form has been signed by the participant.
  
  2. Eligible and available participants will be invited for a 17-day quarantine stay at the viral challenge unit on Day -2 where they will undergo further eligibility checks. Eligible participants will be randomised and will undergo nasal inoculation with the SARS-CoV-2 omicron virus on Day 0. They will be closely monitored for symptoms and adverse events for 14 further days before being discharged. Participants who do not have quantifiable viral load by qRT-PCR by Day 6 may be discharged early from quarantine from Day 8.

  3. 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.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  24/LO/0072

• Date of REC Opinion

  14 Mar 2024

• REC opinion

  Further Information Favourable Opinion