Back to resultsA Study to Determine the Safety and Attack Rate of the Seasonal Flu in Healthy Volunteers
Primary Purpose
Influenza, Human
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
H3N2
Sponsored by
About this trial
This is an interventional other trial for Influenza, Human
Eligibility Criteria
Inclusion criteria:
- Male or female, between 18 and 55 years old (extremes included) at screening.
- In good physical and mental health as determined on the basis of medical history and general physical examination performed at screening.
- Absent or low levels of detectable pre-existing antibodies to influenza virus subtypes, including as a minimum the challenge strain, as determined by a MNT titre of ≤ 20 at screening.
- Negative urine test for selected drugs of abuse at screening and upon check-in at the clinical site.
- Negative alcohol breath test
Female subjects should fulfil one of the following criteria:
- At least 1 year post-menopausal (amenorrhea >12 months and/or follicle-stimulating hormone (FSH) > 30 mIU/mL) prior to screening;
- Surgically sterile (bilateral oophorectomy, hysterectomy, or tubal ligation);
- Will use contraceptives as outlined in inclusion criterion 8 from screening to discharge.
- Female subjects of childbearing potential and male subjects who are sexually active with a female partner of childbearing potential must agree to the use of an effective method of birth control from screening to discharge.
Exclusion criteria:
- Subjects who have received any vaccination within the last 3 months prior to screening or influenza vaccine within the last 12 months prior to screening or who anticipate receiving this during the study.
- Subjects with a diagnosis of influenza or influenza-like illness confirmed by a physician within the last 6 months prior to screening.
- Subjects with a positive result for adventitious agent screening (qualitative PCR testing) for any respiratory virus or bacteria on Day -2.
- Haematology and chemistry parameters, pulse rate and/or blood pressure, and ECG outside the reference range for the population studied and considered as clinical significant by the Investigator.
- Has an acute or chronic medical condition
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
H3N2 10EXP5 TCID50/mL
Arm Description
A/Belgium/4217/2015 (H3N2) (SGS Code: SGS 421-7), Wild-type, influenza A (H3N2) human challenge strain
Outcomes
Primary Outcome Measures
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.
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
Efficacy: observed attack rate
Observed attack rate expressed in percentage
Secondary Outcome Measures
Safety: Incidence of Related virus-emergent adverse events
Safety: Incidence of Related virus-emergent adverse events
Full Information
NCT ID
NCT04372719
First Posted
April 22, 2020
Last Updated
April 29, 2020
Sponsor
SGS Life Sciences, a division of SGS Belgium NV
1. Study Identification
Unique Protocol Identification Number
NCT04372719
Brief Title
A Study to Determine the Safety and Attack Rate of the Seasonal Flu in Healthy Volunteers
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 2, 2016 (Actual)
Primary Completion Date
December 28, 2016 (Actual)
Study Completion Date
December 28, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SGS Life Sciences, a division of SGS Belgium NV
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
single group
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
H3N2 10EXP5 TCID50/mL
Arm Type
Experimental
Arm Description
A/Belgium/4217/2015 (H3N2) (SGS Code: SGS 421-7), Wild-type, influenza A (H3N2) human challenge strain
Intervention Type
Drug
Intervention Name(s)
H3N2
Primary Outcome Measure Information:
Title
safety profile
Description
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
Title
Efficacy: Infectivity
Description
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
Title
Efficacy: observed attack rate
Description
Observed attack rate expressed in percentage
Time Frame
through study completion, an average of 3 months
Secondary Outcome Measure Information:
Title
Safety: Incidence of Related virus-emergent adverse events
Description
Safety: Incidence of Related virus-emergent adverse events
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Male or female, between 18 and 55 years old (extremes included) at screening.
In good physical and mental health as determined on the basis of medical history and general physical examination performed at screening.
Absent or low levels of detectable pre-existing antibodies to influenza virus subtypes, including as a minimum the challenge strain, as determined by a MNT titre of ≤ 20 at screening.
Negative urine test for selected drugs of abuse at screening and upon check-in at the clinical site.
Negative alcohol breath test
Female subjects should fulfil one of the following criteria:
At least 1 year post-menopausal (amenorrhea >12 months and/or follicle-stimulating hormone (FSH) > 30 mIU/mL) prior to screening;
Surgically sterile (bilateral oophorectomy, hysterectomy, or tubal ligation);
Will use contraceptives as outlined in inclusion criterion 8 from screening to discharge.
Female subjects of childbearing potential and male subjects who are sexually active with a female partner of childbearing potential must agree to the use of an effective method of birth control from screening to discharge.
Exclusion criteria:
Subjects who have received any vaccination within the last 3 months prior to screening or influenza vaccine within the last 12 months prior to screening or who anticipate receiving this during the study.
Subjects with a diagnosis of influenza or influenza-like illness confirmed by a physician within the last 6 months prior to screening.
Subjects with a positive result for adventitious agent screening (qualitative PCR testing) for any respiratory virus or bacteria on Day -2.
Haematology and chemistry parameters, pulse rate and/or blood pressure, and ECG outside the reference range for the population studied and considered as clinical significant by the Investigator.
Has an acute or chronic medical condition
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Determine the Safety and Attack Rate of the Seasonal Flu in Healthy Volunteers
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