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

Phase 1

Completed

• Conditions: Influenza, Human
• Interventions: Drug: H3N2

• Registration Number: NCT04372719
• Lead Sponsor: SGS Life Sciences, a division of SGS Belgium NV

Brief 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.

Study Timeline

• Study Start: 2016-11-02
• Primary Completion: 2016-12-28
• Study Completion: 2016-12-28
• Status Verified: 2020-04
• Study First Submitted: 2020-04-22
• Study First Submitted QC: 2020-04-29
• Last Update Submitted: 2020-04-29
• Study First Posted: 2020-05-04
• Last Update Posted: 2020-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
H3N2 10EXP5 TCID50/mL	H3N2	A/Belgium/4217/2015 (H3N2) (SGS Code: SGS 421-7), Wild-type, influenza A (H3N2) human challenge strain

Primary Outcome Measures

Name	Time	Method
Efficacy: observed attack rate	through study completion, an average of 3 months	Observed attack rate expressed in percentage
safety profile	through study completion, an average of 3 months	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.
Efficacy: Infectivity	through study completion, an average of 3 months	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

Secondary Outcome Measures

Name	Time	Method
Safety: Incidence of Related virus-emergent adverse events	through study completion, an average of 1 year	Safety: Incidence of Related virus-emergent adverse events