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

Primary Purpose

Influenza A H1N1

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Infectious Titre 1

Infectious Titre 2

Infectious Titre 3

Infectious Titre 4

About this trial

This is an interventional basic science trial for Influenza A H1N1 focused on measuring Influenza, Human Challenge Trial, H1N1, Flu

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

hVIVO Services Ltd

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Infectious Titre 1

Infectious Titre 2

Infectious Titre 3

Infectious Titre 4

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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%).

Secondary Outcome Measures

Full Information

NCT ID

NCT05572450

First Posted

October 5, 2022

Last Updated

September 12, 2023

Sponsor

Hvivo

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT05572450

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

September 7, 2022 (Actual)

Primary Completion Date

December 19, 2022 (Actual)

Study Completion Date

December 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hvivo

Collaborators

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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)

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza A H1N1

Keywords

Influenza, Human Challenge Trial, H1N1, Flu

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Infectious Titre 1

Arm Type

Experimental

Arm Description

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

Arm Title

Infectious Titre 2

Arm Type

Experimental

Arm Description

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

Arm Title

Infectious Titre 3

Arm Type

Experimental

Arm Description

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

Arm Title

Infectious Titre 4

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Infectious Titre 1

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Infectious Titre 2

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Infectious Titre 3

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Infectious Titre 4

Intervention Description

TBD, depending on outcome of Part A

Primary Outcome Measure Information:

Title

To determine the safe and optimal titre of the influenza challenge virus

Description

Time Frame

Day 0 to Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alex Mann

Organizational Affiliation

hVIVO Services Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

hVIVO Services Ltd

City

London

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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