NCT02525055

Characterisation of a New Wild-Type H3N2 Virus for the Human Viral Challenge Model

A Randomised, Double Blind Study To Characterise Influenza A/Perth/16/2009(H3N2) Virus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Hvivo · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The study will characterise Influenza A/Perth/16/2009(H3N2) virus in healthy participants using the viral challenge model. The study includes two cohorts. Cohort 1: A randomised, double-blind study of 4 titres of Challenge Virus to determine the optimum titre. Cohort 2: An open-label extension arm in which all participants will receive the 'optimum' titre as identified from Cohort 1.

Detailed description

Influenza and its associated diseases are a major cause of morbidity and mortality. The United States Advisory Committee on Immunization Practices recommends influenza vaccination for everyone over 6 months of age. The failure of the flu vaccine in 2014-2015 demonstrates the need for a model that allows the rapid development of novel antivirals, universal/intra-seasonal vaccines, immunomodulators, monoclonal antibodies and other novel treatments. Studies using experimental influenza virus infection in human participants have demonstrated that adult volunteers can be infected by nasal inoculation, and experimental infection is safe and not associated with transmission to contacts. The experimental virus is manufactured in compliance with Good Manufacturing Practice for use in the Human Viral Challenge Model. The investigators chose an H3N2 influenza subtype given that this strain has the most substantial impact in terms of morbidity or mortality annually as described by the Centre for Disease Control . The investigators first subjected the virus batch to rigorous adventitious agent testing, then confirmed the virus to be wild-type by Sanger sequencing and finally determined the virus titres appropriate for human use via the established ferret model. hVIVO team built on its previous experience with other H3N2 and H1N1 viruses to develop this unique model. The first part of study (Cohort 1) was to determine the safety and optimal virus titre in healthy adult volunteers using our unique clinical quarantine facility in London, UK. After the first part of the study was completed, the study was amended to add an older population group (45-64 years old) in order to characterise the course of infection in an age group better representing the at-risk population.

Conditions

• Influenza

Interventions

Type	Name	Description
OTHER	Infectious titre 1 (H3N2)	Infectious titre 1: 2.8 x 10\*3 TCID50/mL
OTHER	Infectious titre 2 (H3N2)	Infectious titre 2: 2.5 x 10\*4 TCID50/mL
OTHER	Infectious titre 3 (H3N2)	Infectious titre 3: 3.6 x 10\*5 TCID50/mL
OTHER	Infectious titre 4 (H3N2)	Infectious titre 4: 4.7 x 10\*6 TCID50/mL
OTHER	Infectious titre 5 (H3N2) (Subjects aged 18 to 45 years old)	Infectious titre 5: 3.5 x 10\*5 TCID50/mL
OTHER	Infectious titre 5 (H3N2) (Subjects aged 46 to 64 years old)	Infectious titre 5: 3.5 x 10\*5 TCID50/mL

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-08-11
• Completion: 2014-08-11
• First posted: 2015-08-17
• Last updated: 2020-01-27
• Results posted: 2020-01-27