A Phase 1 interventional study of H3N2 in Influenza, Human, sponsored by SGS Life Sciences, a division of SGS Belgium NV. Completed. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-04.
Sponsored by SGS Life Sciences, a division of SGS Belgium NV · Phase 1, Interventional, and Other
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.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 36 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →This is the only study on the registry with SGS Life Sciences, a division of SGS Belgium NV as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Female subjects should fulfil one of the following criteria:
Exclusion criteria:
A/Belgium/4217/2015 (H3N2) (SGS Code: SGS 421-7), Wild-type, influenza A (H3N2) human challenge strain
Drug: H3N2
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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