An Exploratory Study To Establish The Dose, Safety, And Pathogenicity Of A New Influenza B Challenge Strain In Healthy Participants 18 To 55 Years Of Age

HRD-vCS-002

This is an exploratory study of an influenza B challenge strain to determine the optimum infectious titer of challenge agent in healthy participants 18 to 55 years of age.

2023-10-03

2024-02-02

2024-02-08

Recruiting

Early phase I

60

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. * Lifetime history of anaphylaxis and/or a lifetime history of severe allergic reaction. * Venous access deemed inadequate for the phlebotomy and cannulation demands of the study. * Significant abnormality of the nose, epistaxis, nasal or sinus surgery. * Recent vaccinations or intention to receive vaccination before the final 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 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 ≥37.9C 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

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2024-02-12