Exploring the safety and dosage of the Omicron COVID-19 virus in healthy adults
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 study is testing different safe doses of the Omicron COVID-19 virus in healthy adults aged 18 to 40 to see how they respond and to ensure it's safe.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Hvivo Industry-sponsored |
| Locations | 1 site (London) |
| Trial ID | NCT06492564 on ClinicalTrials.gov |
What this trial studies
This exploratory study aims to determine the optimal safe dose of the SARS-CoV-2 Omicron (BA.5) challenge strain in healthy participants aged 18 to 40 years. Up to 90 participants will be divided into three cohorts, each receiving different doses of the virus to assess safety and pathogenicity. Participants will undergo a screening phase followed by a quarantine phase where they will be monitored closely for approximately 17 days after receiving the challenge virus. The study will last about 9 months, including follow-up assessments.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 40 who have been vaccinated against COVID-19 and meet specific health criteria.
Not a fit: Patients with a history of respiratory infections or significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help establish safe dosing guidelines for future COVID-19 challenge studies and improve understanding of the Omicron variant.
How similar studies have performed: Other studies involving challenge strains of viruses have shown success, but this specific approach with the Omicron variant is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
London
- hVIVO Services Ltd, 40 Bank Street, Canary Wharf — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Melissa Bevan, MBBS — hVIVO Services Ltd.
- Study coordinator: Alex Mann
- Email: projectadmin@hvivo.com
- Phone: +44(0)207 756 1300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.