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
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
36
Low dose, approximately 10\^4 TCID50/mL
Medium dose, approximately 10\^5 TCID50/mL
High dose, approximately 10\^6 TCID50/mL
hVIVO Services Ltd, 40 Bank Street, Canary Wharf
London, United Kingdom
Occurrence of Adverse Events related to the viral challenge
Number of participants with challenge Agent-emergent adverse events (AEs) at least possibly related to the viral challenge from viral challenge (Day 0) up to the Day 28 follow-up
Time frame: Day 0 to Day 28
Occurrence of Serious Adverse Events and Medically Attended Adverse Events, related to the viral challenge
Occurrence of serious AEs (SAEs) and Medically Attended Adverse Events (MAAEs) related to the viral challenge from viral challenge (Day 0) up to the Day 180 follow-up
Time frame: Day 0 to Day 180
Induces laboratory-confirmed infection in ≥40% of inoculated participants
Quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR)-confirmed SARS-CoV-2 omicron infection, defined as 2 quantifiable (≥ lower limit of quantification \[LLOQ\]) qRT-PCR measurements (reported over 4 planned consecutive assessments within 48 hours), from Day 1 pm to planned discharge from quarantine (Day 14 am).
Time frame: Day 1 to Day 14
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