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

September 12, 2023 updated by: Hvivo

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

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

18 years to 55 years (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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Approximately 10^5.5 TCID50/mL (titre may be adjusted based on stock titre)
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
Approximately 10^4.5 TCID50/mL (titre may be adjusted based on stock titre)
Experimental: Infectious Titre 3
Optional Dose Arm 3 (Part B): to be determined (TBD), depending on outcome of Part A
Other: Infectious Titre 3
To be determined (TBD), depending on outcome of Part A
Experimental: Infectious Titre 4
Optional Dose Arm 4 (Part B): TBD, depending on outcome of Part A
Other: Infectious Titre 4
TBD, depending on outcome of Part A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the safe and optimal titre of the influenza challenge virus
Time Frame: Day 0 to Day 28

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

Collaborators and Investigators

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

Sponsor

Hvivo

Collaborators

Pfizer

Investigators

  • Study Director: Alex Mann, 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)

September 7, 2022

Primary Completion (Actual)

December 19, 2022

Study Completion (Actual)

December 19, 2022

Study Registration Dates

First Submitted

October 5, 2022

First Submitted That Met QC Criteria

October 6, 2022

First Posted (Actual)

October 7, 2022

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRD-vCS-001

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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