Exploring a new influenza A H3N2 virus challenge
An Exploratory Study to Establish the Dose, Safety and Pathogenicity of a New Influenza a H3N2 Challenge Strain in Healthy Participants 18 to 55 Years of Age
This study is testing a new strain of the flu virus in healthy adults aged 18 to 55 to see how safe it is and what dose works best.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Hvivo Industry-sponsored |
| Locations | 1 site (London) |
| Trial ID | NCT06613737 on ClinicalTrials.gov |
What this trial studies
This exploratory study aims to establish the dose, safety, and pathogenicity of a new influenza A H3N2 challenge strain in healthy participants aged 18 to 55. The study consists of two parts: Part A will randomly allocate up to 40 participants to receive one of two virus doses, while Part B may involve additional participants receiving one of the established doses or a new dose based on Part A's outcomes. Participants will undergo a series of clinical assessments and safety monitoring during their stay in a quarantine unit for approximately 8 days following inoculation.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 55 with a body weight of at least 50 kg and a BMI between 18 and 35.
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 lead to improved understanding and management of influenza A H3N2 infections.
How similar studies have performed: Other studies have shown success with similar human challenge approaches in understanding influenza viruses.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent * Adult male or female aged between 18 and 55 years * A total body weight ≥50 kg and body mass index (BMI) ≥18 kg/m2 and ≤35kg/m2. * 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 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 ≥10 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. * Lifetime history of anaphylaxis and/or a lifetime history of severe allergic reaction. * 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 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, recent history or presence of alcohol addiction, excessive consumption of xanthine containing substances or a presence of significant signs and symptoms of nicotine withdrawal on first study visit. * 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
Where this trial is running
London
- hVIVO Services Ltd, 40 Bank Street — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Alexandre Lima, MD-PhD — 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.