Influenza BPhase 2NCT06254820
Dose, Safety, and Pathogenicity of a New Influenza B Strain
A Phase 2 study testing influenza B/Connecticut/1/21 virus part a dose arm 1, influenza B/Connecticut/1/21 virus part a dose arm 2 and influenza B/Connecticut/1/21 virus part b dose 1 in people with Influenza B, run by Hvivo at 1 site in United Kingdom.
Trial summary
This is an exploratory study of an influenza B challenge strain to determine the optimum infectious titer of challenge agent in healthy participants 18 to 55 years of age. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza B
- What is being tested?
- influenza B/Connecticut/1/21 virus part a dose arm 1, influenza B/Connecticut/1/21 virus part a dose arm 2 and influenza B/Connecticut/1/21 virus part b dose 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Oct 2023to 8 Feb 2024
- Phase
- Phase 2
- 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
- Written informed consent
- Adult male or female aged between 18 and 55 years
- A total body weight ≥50 kg and body mass index (BMI) ≥18 kg/m2 and ≤35kg/m2
- In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participant safety.
- Documented medical history
- Adherence to contraception requirements
- Serosuitable for the challenge virus.
Who cannot join
- History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract (LRT) infection within 4 weeks prior to the first study visit.
- Any history or evidence of any clinically significant or currently active disease.
- Any participants who have smoked ≥10 pack years at any time.
- Female participants who are breastfeeding, or have been pregnant within 6 months prior to the study, or have a positive pregnancy test at any point during screening or prior to inoculation.
- Lifetime history of anaphylaxis and/or a lifetime history of severe allergic reaction.
- Venous access deemed inadequate for the phlebotomy and cannulation demands of the study.
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- Significant abnormality of the nose, epistaxis, nasal or sinus surgery.
- Recent vaccinations or intention to receive vaccination before the final follow up visit.
- Receipt of blood or blood products, or loss (including blood donations) of 550 mL or more of blood during the 3 months prior to the planned inoculation or planned during the 3 months after the final visit.
- Recent receipt of investigational drugs or challenge viruses.
- Use or anticipated use during the conduct of the study of concomitant medications (prescription and/or non-prescription), including vitamins or herbal and dietary supplements within the specified windows.
- Positive drugs of abuse test or recent history or presence of alcohol addiction
- A forced expiratory volume in 1 second (FEV1) <80%.
- Positive HIV, hepatitis B virus, or hepatitis C virus test.
- Presence of fever, defined as participant presenting with a temperature reading of ≥37.9C on Day -2/-1 and/or pre-inoculation on Day 0.
- Those employed or immediate relatives of those employed at hVIVO or the sponsor.
- Any other reason, in the opinion of the investigator deems the participant unsuitable for the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
QMB
London, E1 2AX
Victoria Parker, MBBS, +442077561300, projectadmin@hvivo.com
Victoria Parker, MBBS
About this study
Official title: An Exploratory Study To Establish The Dose, Safety, And Pathogenicity Of A New Influenza B Challenge Strain In Healthy Participants 18 To 55 Years Of Age
This is an exploratory study of an influenza B challenge strain to determine the optimum infectious titer of challenge agent in healthy participants 18 to 55 years of age.
Read the detailed description
This is an exploratory study of an influenza B challenge strain to determine the optimum safe infectious titer of challenge agent in healthy participants 18 to 55 years of age. A total of up to 80 participants may be given influenza B challenge virus. The study will be conducted in 2 parts. In Part A, 40 participants will be randomly allocated to one of two groups to be given one of two virus doses (Virus Dose 1 or Virus Dose 2). Based on the outcome of Part A, participants in Part B, may be given Virus Dose 1, Virus Dose 2, or another virus dose (e.g., Virus Dose 3).
Each participant will remain in the study for approximately 1 month from admission to quarantine to the last clinic visit.
The study is divided into three phases:
- Screening phase: Screening will occur between Day -90 to Day -2/-1. has been signed by the participant.
- Quarantine phase: Participants will stay in the quarantine unit for approximately 11 days (from Day -2/-1 to Day 8). One or two days prior to the day of inoculation with the challenge virus, participants will be admitted to quarantine where their eligibility will be reassessed. If participants remain eligible for the study, they will receive the challenge virus on Day 0. Participants will undergo a range of clinical assessments and safety monitoring for the entirety of their stay in quarantine. Participants will be discharged from the quarantine unit on Day 8 (or may remain longer at the principal investigator's discretion).
- Outpatient phase: Final follow-up visit 28 days (±3 days) after the day they receive the virus. Their symptoms will be reassessed, and a complete safety examination performed.
- Conditions
- Influenza B
- Being tested
- influenza B/Connecticut/1/21 virus part a dose arm 1, influenza B/Connecticut/1/21 virus part a dose arm 2, influenza B/Connecticut/1/21 virus part b dose 1, influenza B/Connecticut/1/21 virus part b dose 2
- Keywords
- Influenza, Flu, Human Challenge Trials, Flu B
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
influenza B/Connecticut/1/21 virus part a dose arm 1Biological
Medium dose, expected to be approximately 10^6 tissue culture infective dose 50% (TCID50)/mL (titer may be adjusted based on stock titer)
influenza B/Connecticut/1/21 virus part a dose arm 2Biological
High dose, expected to be approximately 10^7 TCID50/ mL (titer may be adjusted based on stock titer)
influenza B/Connecticut/1/21 virus part b dose 1Biological
Extension of one of the Part A dose arms; which one is to be determined (TBD) depending on outcome of Part A, AND/OR Dose Arm 3
influenza B/Connecticut/1/21 virus part b dose 2Biological
Addition of a 3rd dose, TBD depending on outcome of Part A
| Study group | Role | What they receive |
|---|---|---|
| Part A Dose Arm 1 | Experimental | Medium dose, expected to be approximately 10^6 tissue culture infective dose 50% (TCID50)/mL (titer may be adjusted based on stock titer) Receives: Biological: influenza B/Connecticut/1/21 virus part a dose arm 1 |
| Part A Dose Arm 2 | Experimental | Dose Arm 2: High dose, expected to be approximately 10^7 TCID50/ mL (titer may be adjusted based on stock titer) Receives: Biological: influenza B/Connecticut/1/21 virus part a dose arm 2 |
| Part B Dose Extension: | Experimental | Extension of one of the Part A dose arms; which one is to be determined (TBD) depending on outcome of Part A, AND/OR Receives: Biological: influenza B/Connecticut/1/21 virus part b dose 1 |
| Part B Dose Arm 3 | Experimental | Addition of a 3rd dose, TBD depending on outcome of Part A Receives: Biological: influenza B/Connecticut/1/21 virus part b dose 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of AEs and SAEs
Measuring the occurrence of AEs and SAEs as assessed by CTCAE v4.0 during the first 28 days of treatment in >/=40% of participants with laboratory confirmed infection.
Measured: Day 0 - Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start3 Oct 2023
- Primary completion2 Feb 2024 (estimated)
- Study completion8 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza BStudies 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an exploratory study of an influenza B challenge strain to determine the optimum infectious titer of challenge agent in healthy participants 18 to 55 years of age
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvivo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Victoria Parker, MBBS, Principal investigator, hVIVO Services Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254820
- Sponsor's protocol ID
- HRD-vCS-002
- Status last verified
- Feb 2024
- First submitted
- 14 Nov 2023
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study To Establish The Dose, Safety, And Pathogenicity Of A New Influenza B Challenge Strain In Healthy Participants 18 To 55 Years Of Age
- ClinicalTrials.gov ID
- NCT06254820
- Acronym / sponsor ID
- HRD-vCS-002
- Conditions
- Influenza B
- Keywords
- Influenza, Flu, Human Challenge Trials, Flu B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- HvivoIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 2 Feb 2024 (estimated)
- Study completion
- 8 Feb 2024 (estimated)
- First posted
- 12 Feb 2024 (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 an exploratory study of an influenza B challenge strain to determine the optimum infectious titer of challenge agent in healthy participants 18 to 55 years of age.
Detailed description
This is an exploratory study of an influenza B challenge strain to determine the optimum safe infectious titer of challenge agent in healthy participants 18 to 55 years of age. A total of up to 80 participants may be given influenza B challenge virus. The study will be conducted in 2 parts. In Part A, 40 participants will be randomly allocated to one of two groups to be given one of two virus doses (Virus Dose 1 or Virus Dose 2). Based on the outcome of Part A, participants in Part B, may be given Virus Dose 1, Virus Dose 2, or another virus dose (e.g., Virus Dose 3).
Each participant will remain in the study for approximately 1 month from admission to quarantine to the last clinic visit.
The study is divided into three phases:
- Screening phase: Screening will occur between Day -90 to Day -2/-1. has been signed by the participant.
- Quarantine phase: Participants will stay in the quarantine unit for approximately 11 days (from Day -2/-1 to Day 8). One or two days prior to the day of inoculation with the challenge virus, participants will be admitted to quarantine where their eligibility will be reassessed. If participants remain eligible for the study, they will receive the challenge virus on Day 0. Participants will undergo a range of clinical assessments and safety monitoring for the entirety of their stay in quarantine. Participants will be discharged from the quarantine unit on Day 8 (or may remain longer at the principal investigator's discretion).
- Outpatient phase: Final follow-up visit 28 days (±3 days) after the day they receive the virus. Their symptoms will be reassessed, and a complete safety examination performed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- This is an exploratory study of an influenza B challenge strain to determine the optimum infectious titer of challenge agent in healthy participants 18 to 55 years of age
| Arm | Type | Receives |
|---|---|---|
| Part A Dose Arm 1 | Experimental | Biological: influenza B/Connecticut/1/21 virus part a dose arm 1Medium dose, expected to be approximately 10^6 tissue culture infective dose 50% (TCID50)/mL (titer may be adjusted based on stock titer) |
| Part A Dose Arm 2 | Experimental | Biological: influenza B/Connecticut/1/21 virus part a dose arm 2Dose Arm 2: High dose, expected to be approximately 10^7 TCID50/ mL (titer may be adjusted based on stock titer) |
| Part B Dose Extension: | Experimental | Biological: influenza B/Connecticut/1/21 virus part b dose 1Extension of one of the Part A dose arms; which one is to be determined (TBD) depending on outcome of Part A, AND/OR |
| Part B Dose Arm 3 | Experimental | Biological: influenza B/Connecticut/1/21 virus part b dose 2Addition of a 3rd dose, TBD depending on outcome of Part A |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Written informed consent
- Adult male or female aged between 18 and 55 years
- A total body weight ≥50 kg and body mass index (BMI) ≥18 kg/m2 and ≤35kg/m2
- In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participant safety.
- Documented medical history
Key exclusion criteria (17 listed)
- History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract (LRT) infection within 4 weeks prior to the first study visit.
- Any history or evidence of any clinically significant or currently active disease.
- Any participants who have smoked ≥10 pack years at any time.
- Female participants who are breastfeeding, or have been pregnant within 6 months prior to the study, or have a positive pregnancy test at any point during screening or prior to inoculation.
- Lifetime history of anaphylaxis and/or a lifetime history of severe allergic reaction.
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 |
|---|---|---|
| influenza B/Connecticut/1/21 virus part a dose arm 1Medium dose, expected to be approximately 10^6 tissue culture infective dose 50% (TCID50)/mL (titer may be adjusted based on stock titer) | Biological | Part A Dose Arm 1 |
| influenza B/Connecticut/1/21 virus part a dose arm 2High dose, expected to be approximately 10^7 TCID50/ mL (titer may be adjusted based on stock titer) | Biological | Part A Dose Arm 2 |
| influenza B/Connecticut/1/21 virus part b dose 1Extension of one of the Part A dose arms; which one is to be determined (TBD) depending on outcome of Part A, AND/OR Dose Arm 3 | Biological | Part B Dose Extension: |
| influenza B/Connecticut/1/21 virus part b dose 2Addition of a 3rd dose, TBD depending on outcome of Part A | Biological | Part B Dose Arm 3 |
Primary outcome
Occurrence of AEs and SAEs
Time frame: Day 0 - Day 28
Measuring the occurrence of AEs and SAEs as assessed by CTCAE v4.0 during the first 28 days of treatment in >/=40% of participants with laboratory confirmed infection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Victoria Parker, MBBS principal investigator
hVIVO Services Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing influenza B/Connecticut/1/21 virus part a dose arm 1, influenza B/Connecticut/1/21 virus part a dose arm 2 and influenza B/Connecticut/1/21 virus part b dose 1 in people with Influenza B, run by Hvivo at 1 site in United Kingdom.
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 7 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alex Mann (+44(0)207 756 1300, projectadmin@hvivo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of AEs and SAEs (time frame: Day 0 - Day 28). 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 12 Feb 2024.