NCT04372719

A Study to Determine the Safety and Attack Rate of the Seasonal Flu in Healthy Volunteers

An Open-Label, Ascending Dose Study to Determine the Safety and Attack Rate of a Wild Type, Seasonal H3N2 Influenza Challenge Agent in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: SGS Life Sciences, a division of SGS Belgium NV · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a non-controlled, open-label, single-centre, dose-escalation study to determine the safety, infectivity and immunology of the potential novel influenza virus H3N2 challenge strain. The term 'challenge agent' used in this protocol refers to the Influenza virus H3N2 A/Belgium/4217/2015. The study utilises an adaptive study design and consists of 2 parts.

Detailed description

In Part 1, the primary objective is to determine the viral challenge strain dose that has an acceptable safety profile and an observed attack rate of \>60% (i.e., at least 8 out of 12 subjects should be infected). After Part 1, a formal interim analysis will be performed to select the viral challenge strain dose for Part 2 by evaluating the primary objective of Part 1. In case no viral challenge strain dose can be selected, the study will not proceed to Part 2. In Part 2, the primary objective is to determine the infectivity rate in healthy volunteers of the selected viral challenge strain dose for use in subsequent human challenge intervention studies. All subjects will be screened prior to viral inoculation to assess their suitability to enter the study. Eligible subjects will be admitted to the clinical centre for a single intranasal inoculation with influenza A (H3N2). In this study, up to 64 healthy subjects will receive the investigational challenge agent: 36 subjects in Part 1 and 18 or 28 subjects in Part 2.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
DRUG	H3N2

Timeline

• Start date: 2016-11-02
• Primary completion: 2016-12-28
• Completion: 2016-12-28
• First posted: 2020-05-04
• Last updated: 2020-05-04