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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
36
safety profile
Number of subjects with SAEs considered by the Investigator to be related to the challenge agent, moderate or severe lower respiratory symptoms as indicated on the symptom score card, or confirmed cytokine-related AEs.
Time frame: through study completion, an average of 3 months
Efficacy: Infectivity
Attack rate defined as number of inoculated subjects with any of the following: * Fever * At least one other (i.e., not fever) influenza symptom At least 2 consecutive swabs positive for H3N2
Time frame: through study completion, an average of 3 months
Efficacy: observed attack rate
Observed attack rate expressed in percentage
Time frame: through study completion, an average of 3 months
Safety: Incidence of Related virus-emergent adverse events
Safety: Incidence of Related virus-emergent adverse events
Time frame: through study completion, an average of 1 year
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