Dose, Safety, and Pathogenicity of a New Influenza B Strain

February 9, 2024 updated by: Hvivo

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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:

  1. Screening phase: Screening will occur between Day -90 to Day -2/-1. has been signed by the participant.

  2. 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).

  3. 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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, E1 2AX
        • Recruiting
        • QMB
        • Contact:
        • Principal Investigator:
          • Victoria Parker, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A Dose Arm 1
Medium dose, expected to be approximately 10^6 tissue culture infective dose 50% (TCID50)/mL (titer may be adjusted based on stock titer)
Biological: influenza B/Connecticut/1/21 virus part a dose arm 1
Medium dose, expected to be approximately 10^6 tissue culture infective dose 50% (TCID50)/mL (titer may be adjusted based on stock titer)
Experimental: Part A Dose Arm 2
Dose Arm 2: High dose, expected to be approximately 10^7 TCID50/ mL (titer may be adjusted based on stock titer)
Biological: influenza B/Connecticut/1/21 virus part a dose arm 2
High dose, expected to be approximately 10^7 TCID50/ mL (titer may be adjusted based on stock titer)
Experimental: Part B Dose Extension:
Extension of one of the Part A dose arms; which one is to be determined (TBD) depending on outcome of Part A, AND/OR
Biological: influenza B/Connecticut/1/21 virus part b dose 1
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
Experimental: Part B Dose Arm 3
Addition of a 3rd dose, TBD depending on outcome of Part A
Biological: influenza B/Connecticut/1/21 virus part b dose 2
Addition of a 3rd dose, TBD depending on outcome of Part A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0 - Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvivo

Collaborators

Pfizer

Investigators

  • Principal Investigator: Victoria Parker, MBBS, hVIVO Services Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2023

Primary Completion (Estimated)

February 2, 2024

Study Completion (Estimated)

February 8, 2024

Study Registration Dates

First Submitted

November 14, 2023

First Submitted That Met QC Criteria

February 9, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRD-vCS-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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