Influenza A H1N1NCT05572450
Dose, Safety, and Pathogenicity of a New Influenza H1N1 Challenge Strain
A study testing Infectious Titre 1, Infectious Titre 2 and Infectious Titre 3 in people with Influenza A H1N1, run by Hvivo at 1 site in United Kingdom.
Trial summary
A total of up to 90 participants may be given H1N1 influenza challenge virus. 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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza A H1N1
- What is being tested?
- Infectious Titre 1, Infectious Titre 2 and Infectious Titre 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Sep 2022to 19 Dec 2022
- Phase
- Interventional
- 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.
Show all 17Show fewer
- 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.
About this study
Official title: An Exploratory Study to Establish the Dose, Safety and Pathogenicity of a New Influenza H1N1 Challenge Strain in Healthy Participants 18 to 55 Years of Age
A total of up to 90 participants may be given H1N1 influenza challenge virus.
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)
Read the detailed description
Influenza viruses are associated with significant human disease and cause annual epidemics during autumn and winter. Although most people recover within 1 to 2 weeks without requiring medical attention, seasonal influenza yearly results in approximately 3 to 5 million cases of severe illness and up to 500,000 deaths worldwide, particularly among the very young, elderly, and chronically ill.
The H1N1 virus used for the challenge virus originated from a cell-culture derived candidate vaccine virus (ccCVV), provided by the Centers for Disease Control an Prevention (CDC) in the USA.
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)
- Conditions
- Influenza A H1N1
- Being tested
- Infectious Titre 1, Infectious Titre 2, Infectious Titre 3, Infectious Titre 4
- Keywords
- Influenza, Human Challenge Trial, H1N1, Flu
- Medical subject headings
- Orthomyxoviridae Infections, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infectious Titre 1Other
Approximately 10^5.5 TCID50/mL (titre may be adjusted based on stock titre)
Infectious Titre 2Other
Approximately 10^4.5 TCID50/mL (titre may be adjusted based on stock titre)
Infectious Titre 3Other
To be determined (TBD), depending on outcome of Part A
Infectious Titre 4Other
TBD, depending on outcome of Part A
| Study group | Role | What they receive |
|---|---|---|
| Infectious Titre 1 | Experimental | Dose Arm 1 (Part A): Approximately 10^5.5 TCID50/mL (titre may be adjusted based on stock titre) Receives: Other: Infectious Titre 1 |
| Infectious Titre 2 | Experimental | Dose Arm 2 (Part A): Approximately 10^4.5 TCID50/mL (titre may be adjusted based on stock titre) Receives: Other: Infectious Titre 2 |
| Infectious Titre 3 | Experimental | Optional Dose Arm 3 (Part B): to be determined (TBD), depending on outcome of Part A Receives: Other: Infectious Titre 3 |
| Infectious Titre 4 | Experimental | Optional Dose Arm 4 (Part B): TBD, depending on outcome of Part A Receives: Other: Infectious Titre 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safe and optimal titre of the influenza challenge virus
To identify a safe and infectious dose of wild-type influenza virus in healthy participants, suitable for future intervention studies that:
- Has an acceptable safety profile as measured by:
Occurrence of adverse events (AEs) related to the viral challenge
Occurrence of serious AEs (SAEs) related to the viral challenge
Induces laboratory-confirmed infection in ≥40% of inoculated participants (ideally between 50% and 80%).
Measured: Day 0 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start7 Sep 2022
- Primary completion19 Dec 2022
- Study completion19 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza A H1N1Studies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvivo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Alex Mann, Study director, hVIVO Services Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572450
- Sponsor's protocol ID
- HRD-vCS-001
- Status last verified
- Sep 2023
- First submitted
- 5 Oct 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. 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 H1N1 Challenge Strain in Healthy Participants 18 to 55 Years of Age
- ClinicalTrials.gov ID
- NCT05572450
- Acronym / sponsor ID
- HRD-vCS-001
- Conditions
- Influenza A H1N1
- Keywords
- Influenza, Human Challenge Trial, H1N1, Flu
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- HvivoIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 19 Dec 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 7 Oct 2022 (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.
A total of up to 90 participants may be given H1N1 influenza challenge virus.
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)
Detailed description
Influenza viruses are associated with significant human disease and cause annual epidemics during autumn and winter. Although most people recover within 1 to 2 weeks without requiring medical attention, seasonal influenza yearly results in approximately 3 to 5 million cases of severe illness and up to 500,000 deaths worldwide, particularly among the very young, elderly, and chronically ill.
The H1N1 virus used for the challenge virus originated from a cell-culture derived candidate vaccine virus (ccCVV), provided by the Centers for Disease Control an Prevention (CDC) in the USA.
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)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Infectious Titre 1 | Experimental | Other: Infectious Titre 1Dose Arm 1 (Part A): Approximately 10^5.5 TCID50/mL (titre may be adjusted based on stock titre) |
| Infectious Titre 2 | Experimental | Other: Infectious Titre 2Dose Arm 2 (Part A): Approximately 10^4.5 TCID50/mL (titre may be adjusted based on stock titre) |
| Infectious Titre 3 | Experimental | Other: Infectious Titre 3Optional Dose Arm 3 (Part B): to be determined (TBD), depending on outcome of Part A |
| Infectious Titre 4 | Experimental | Other: Infectious Titre 4Optional Dose Arm 4 (Part B): 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 |
|---|---|---|
| Infectious Titre 1Approximately 10^5.5 TCID50/mL (titre may be adjusted based on stock titre) | Other | Infectious Titre 1 |
| Infectious Titre 2Approximately 10^4.5 TCID50/mL (titre may be adjusted based on stock titre) | Other | Infectious Titre 2 |
| Infectious Titre 3To be determined (TBD), depending on outcome of Part A | Other | Infectious Titre 3 |
| Infectious Titre 4TBD, depending on outcome of Part A | Other | Infectious Titre 4 |
Primary outcome
To determine the safe and optimal titre of the influenza challenge virus
Time frame: Day 0 to Day 28
To identify a safe and infectious dose of wild-type influenza virus in healthy participants, suitable for future intervention studies that: • Has an acceptable safety profile as measured by: Occurrence of adverse events (AEs) related to the viral challenge Occurrence of serious AEs (SAEs) related to the viral challenge Induces laboratory-confirmed infection in ≥40% of inoculated participants (ideally between 50% and 80%).
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 13 Sep 2023.
Related trials for Influenza A H1N1
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
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.
Alex Mann study director
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 study testing Infectious Titre 1, Infectious Titre 2 and Infectious Titre 3 in people with Influenza A H1N1, 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: finished, as of the sponsor's last update on 13 Sep 2023. 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.
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?
To determine the safe and optimal titre of the influenza challenge virus (time frame: Day 0 to 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 13 Sep 2023.