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

NCT06254820 | Recruiting Phase 2

• 1 other identifier: HRD-vCS-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza B

Keywords

Influenza; Flu; Human Challenge Trials; Flu B

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0 - Day 28

Study Arms (4)

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)

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)

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

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

Biological: influenza B/Connecticut/1/21 virus part b dose 2

Interventions

influenza B/Connecticut/1/21 virus part a dose arm 1 BIOLOGICAL

Medium 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 1

influenza B/Connecticut/1/21 virus part a dose arm 2 BIOLOGICAL

High dose, expected to be approximately 10\^7 TCID50/ mL (titer may be adjusted based on stock titer)

Part A Dose Arm 2

influenza B/Connecticut/1/21 virus part b dose 1 BIOLOGICAL

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

Part B Dose Extension:

influenza B/Connecticut/1/21 virus part b dose 2 BIOLOGICAL

Addition of a 3rd dose, TBD depending on outcome of Part A

Part B Dose Arm 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hvivo: lead
• Pfizer: collaborator

Study Sites (1)

QMB

London, E1 2AX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Victoria Parker, MBBS

  hVIVO Services Ltd.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex Mann

CONTACT

+44(0)207 756 1300; projectadmin@hvivo.com

Victoria Parker, MBBS

CONTACT

+44(0)207 756 1300; projectadmin@hvivo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participant and Investigator. Investigator will be blinded in Part A of the study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: November 14, 2023
• First Posted: February 12, 2024
• Study Start: October 3, 2023
• Primary Completion: February 2, 2024
• Study Completion: February 8, 2024
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)