Influenza, HumanPhase 1NCT04372719
A Study to Determine the Safety and Attack Rate of the Seasonal Flu in Healthy Volunteers
A Phase 1 study testing H3N2 in people with Influenza, Human, run by SGS Life Sciences, a division of SGS Belgium NV.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- H3N2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2016to 28 Dec 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
- 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
About this study
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
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.
Read the 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
- Being tested
- H3N2
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H3N2Drug
| Study group | Role | What they receive |
|---|---|---|
| H3N2 10EXP5 TCID50/mL | Experimental | A/Belgium/4217/2015 (H3N2) (SGS Code: SGS 421-7), Wild-type, influenza A (H3N2) human challenge strain Receives: Drug: H3N2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: through study completion, an average of 3 months
Efficacy: observed attack rate
Observed attack rate expressed in percentage
Measured: through study completion, an average of 3 months
Secondary outcomes (1)
Safety: Incidence of Related virus-emergent adverse events
Safety: Incidence of Related virus-emergent adverse events
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start2 Nov 2016
- Primary completion28 Dec 2016
- Study completion28 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- SGS Life Sciences, a division of SGS Belgium NV
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372719
- Sponsor's protocol ID
- CHAMP-H3N2
- Status last verified
- Apr 2020
- First submitted
- 22 Apr 2020
- Last updated
- 4 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04372719
- Acronym / sponsor ID
- CHAMP-H3N2
- Conditions
- Influenza, Human
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- SGS Life Sciences, a division of SGS Belgium NVUniversity, hospital or other
- Study start
- 2 Nov 2016 (actual)
- Primary completion
- 28 Dec 2016 (actual)
- Study completion
- 28 Dec 2016 (actual)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single group
| Arm | Type | Receives |
|---|---|---|
| H3N2 10EXP5 TCID50/mL | Experimental | Drug: H3N2A/Belgium/4217/2015 (H3N2) (SGS Code: SGS 421-7), Wild-type, influenza A (H3N2) human challenge strain |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H3N2 | Drug | H3N2 10EXP5 TCID50/mL |
Primary outcome
safety profile
Time frame: 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
Time frame: 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
Efficacy: observed attack rate
Time frame: through study completion, an average of 3 months
Observed attack rate expressed in percentage
1 secondary outcome
Safety: Incidence of Related virus-emergent adverse events
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2020.
- Individual participant dataSharing planned: No
Related trials for Influenza, Human
Active, not recruitingObservational study
SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
Spinal Cord Injuries, Traumatic Spinal Cord Injury
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
RecruitingPhase 1
A Trial to Evaluate the Effect of CD388/MK1406 on the Immunogenicity of Fluzone® HD Vaccine (CD388.SQ.1.08/MK-1406-007)
Healthy Participants
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Active, not recruiting
Conversational AI for Adult Flu Vaccination Decisions
Influenza, Human, Vaccine Hesitancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing H3N2 in people with Influenza, Human, run by SGS Life Sciences, a division of SGS Belgium NV.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety profile (time frame: through study completion, an average of 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2020.