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

NCT06492564 | Completed Early Phase 1

• 1 other identifier: HRD-vCS-003
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

SARS-CoV-2 Infection

Keywords

SARS-CoV-2; Omicron; COVID-19; Human Challenge Trials

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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).

  Day 1 to Day 14

Study Arms (3)

Dose 1

EXPERIMENTAL

Low dose, expected to be approximately 10\^4 tissue culture infective dose 50% (TCID50)/mL (titer may be adjusted based on stock titer)

Biological: SARS-CoV-2 omicron virus dose arm 1

Dose 2

EXPERIMENTAL

Medium dose, expected to be approximately 10\^5 tissue culture infective dose 50% (TCID50)/mL (titer may be adjusted based on stock titer)

Biological: SARS-CoV-2 omicron virus dose arm 2

Dose 3

EXPERIMENTAL

High dose, expected to be approximately 10\^6 tissue culture infective dose 50% (TCID50)/mL (titer may be adjusted based on stock titer)

Biological: SARS-CoV-2 omicron virus dose arm 3

Interventions

SARS-CoV-2 omicron virus dose arm 1 BIOLOGICAL

Low dose, approximately 10\^4 TCID50/mL

Dose 1

SARS-CoV-2 omicron virus dose arm 2 BIOLOGICAL

Medium dose, approximately 10\^5 TCID50/mL

Dose 2

SARS-CoV-2 omicron virus dose arm 3 BIOLOGICAL

High dose, approximately 10\^6 TCID50/mL

Dose 3

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent
• Adult male or female aged between 18 and 40 years
• A total body weight ≥50 kg and body mass index (BMI) ≥18 kg/m2 and ≤28kg/m2. The upper limit of BMI may be increased to ≤30kg/m2 at the PI's discretion, in the case of physically fit muscular individuals.
• In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participant safety.
• Documented medical history
• Adherence to contraception requirements
• Serosuitable for the challenge virus
• Participants must have been previously vaccinated with a COVID-19 vaccine licensed for use in the UK and completed the course

You may not qualify if:

• History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract (LRT) infection within 4 weeks prior to the first study visit.
• Any history or evidence of any clinically significant or currently active disease.
• Any participants who have smoked ≥5 pack years at any time.
• Female participants who are breastfeeding, or have been pregnant within 6 months prior to the study, or have a positive pregnancy test at any point during screening or prior to inoculation.
• Any history of anaphylaxis and/or a any history of severe allergic reaction.
• Venous access deemed inadequate for the phlebotomy and cannulation demands of the study.
• History of severe COVID-19 or severe complication of any other viral disease.
• Participants with no knowledge of their family history, as deemed appropriate by the PI
• Significant abnormality of the nose, includes loss of or alterations in smell or taste,nasal polyps, epistaxis, nasal or sinus surgery.
• Recent vaccinations or intention to receive vaccination before the Day 28 follow up visit. Receipt of COVID-19 vaccine in the last 3 months prior to inoculation and/or a diagnosis of COVID 19 confirmed by a physician within the last 6 months prior to screening or at any time between screening and quarantine admission.
• Receipt of blood or blood products, or loss (including blood donations) of 550 mL or more of blood during the 3 months prior to the planned inoculation or planned during the 3 months after the final visit.
• Recent receipt of investigational drugs or challenge viruses.
• Use or anticipated use during the conduct of the study of concomitant medications (prescription and/or non-prescription), including vitamins or herbal and dietary supplements within the specified windows.
• Positive drugs of abuse test or recent history or presence of alcohol addiction
• A forced expiratory volume in 1 second (FEV1) \<80%.

Sponsors & Collaborators

• Hvivo: lead

Study Sites (1)

hVIVO Services Ltd, 40 Bank Street, Canary Wharf

London, E14 5NR, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Melissa Bevan, MBBS

  hVIVO Services Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 9, 2024
• Study Start: December 2, 2024
• Primary Completion: October 16, 2025
• Study Completion: October 16, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)