Scientists deliberately infect volunteers with omicron to study COVID-19
NCT ID NCT06492564
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study involved 36 healthy adults aged 18 to 40 who were given a controlled dose of the Omicron BA.5 virus. The goal was to find a safe dose that causes infection in at least 40% of people, while monitoring side effects. This type of research helps scientists better understand the virus and could speed up development of new vaccines and treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SARS-CoV-2 Omicron BA.5 virus (live virus for controlled infection)
- What this could lead to
- If successful, this study could help researchers safely test new vaccines and treatments for COVID-19 using a controlled human infection model.
- What could go wrong
- This is a very early, small study (36 people) designed to understand the virus, not to treat or prevent disease. The results may not apply to the general population.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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36 people
The number who actually took part.
- Started
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Dec 2024
- Finished
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Oct 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 40 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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hVIVO Services Ltd, 40 Bank Street, Canary Wharf
London, E14 5NR, United Kingdom
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Other studies related to the condition(s) this trial covers.
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