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

NCT05572450 | Completed

• 1 other identifier: HRD-vCS-001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Influenza A H1N1

Keywords

Influenza; Human Challenge Trial; H1N1; Flu

Outcome Measures

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%).

  Day 0 to Day 28

Study Arms (4)

Infectious Titre 1

EXPERIMENTAL

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

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)

Other: Infectious Titre 2

Infectious Titre 3

EXPERIMENTAL

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

Other: Infectious Titre 3

Infectious Titre 4

EXPERIMENTAL

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

Other: Infectious Titre 4

Interventions

Infectious Titre 1 OTHER

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

Infectious Titre 1

Infectious Titre 2 OTHER

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

Infectious Titre 2

Infectious Titre 3 OTHER

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

Infectious Titre 3

Infectious Titre 4 OTHER

TBD, depending on outcome of Part A

Infectious Titre 4

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)

hVIVO Services Ltd

London, United Kingdom

Location

MeSH Terms

Conditions

Orthomyxoviridae Infections; Influenza, Human

Condition Hierarchy (Ancestors)

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

Study Officials

• Alex Mann

  hVIVO Services Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 7, 2022
• Study Start: September 7, 2022
• Primary Completion: December 19, 2022
• Study Completion: December 19, 2022
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

GB (1)