Status:
COMPLETED
Dose, Safety and Pathogenicity of SARS-CoV-2 (COVID-19) Omicron Virus (BA.5)
Lead Sponsor:
Hvivo
Conditions:
SARS-CoV-2 Infection
Eligibility:
All Genders
18-40 years
Phase:
EARLY_PHASE1
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
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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%.
- Positive HIV, hepatitis B virus, or hepatitis C virus test.
- Presence of fever, defined as participant presenting with a temperature reading of ≥37.9°C on Day -2/-1 and/or pre-inoculation on Day 0.
- Those employed or immediate relatives of those employed at hVIVO or the sponsor.
- Any other reason, in the opinion of the investigator deems the participant unsuitable for the study
- Sensitivity to any of the study interventions, challenge agent or components thereof (including lactose), or drug or other allergy that, in the opinion of the PI/investigator, contraindicates participation in the study.
Key Trial Info
Start Date :
December 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06492564
Start Date
December 2 2024
End Date
October 16 2025
Last Update
November 21 2025
Active Locations (1)
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1
hVIVO Services Ltd, 40 Bank Street, Canary Wharf
London, United Kingdom, E14 5NR