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CompletedNCT05572450Updated Sep 13, 2023

Dose, Safety, and Pathogenicity of a New Influenza H1N1 Challenge Strain

An interventional study of Infectious Titre 1 and Infectious Titre 2 in Influenza A H1N1, sponsored by Hvivo. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-13.

Sponsored by Hvivo · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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).

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)

02

Conditions studied

  • Influenza A H1N1

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Keywords

  • Influenza
  • Human Challenge Trial
  • H1N1
  • Flu
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Infectious Titre 1

    Dose Arm 1 (Part A): Approximately 10\^5.5 TCID50/mL (titre may be adjusted based on stock titre)

    Other: Infectious Titre 1

  • Experimental
    Infectious Titre 2

    Dose Arm 2 (Part A): Approximately 10\^4.5 TCID50/mL (titre may be adjusted based on stock titre)

    Other: Infectious Titre 2

  • Experimental
    Infectious Titre 3

    Optional Dose Arm 3 (Part B): to be determined (TBD), depending on outcome of Part A

    Other: Infectious Titre 3

  • Experimental
    Infectious Titre 4

    Optional Dose Arm 4 (Part B): TBD, depending on outcome of Part A

    Other: Infectious Titre 4

Interventions

  • OtherInfectious Titre 1

    Approximately 10\^5.5 TCID50/mL (titre may be adjusted based on stock titre)

  • OtherInfectious Titre 2

    Approximately 10\^4.5 TCID50/mL (titre may be adjusted based on stock titre)

  • OtherInfectious Titre 3

    To be determined (TBD), depending on outcome of Part A

  • OtherInfectious Titre 4

    TBD, depending on outcome of Part A

05

What researchers measure

Primary outcomes

  1. 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%).

    Time frame: Day 0 to Day 28

06

Study locations

1 site
  • hVIVO Services Ltd
    London, United Kingdom
07

Registry details

Key details

Study ID
NCT05572450
Lead sponsor
Hvivo
Collaborators
Pfizer
Responsible party
Sponsor
First posted
Oct 7, 2022
Start date
Sep 7, 2022
Primary completion
Dec 19, 2022
Completion
Dec 19, 2022
Last update
Sep 13, 2023

Study contacts

Alex Mann
study director · hVIVO Services Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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