NCT05572450

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Hvivo · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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)

Conditions

• Influenza A H1N1

Interventions

Type	Name	Description
OTHER	Infectious Titre 1	Approximately 10\^5.5 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)
OTHER	Infectious Titre 3	To be determined (TBD), depending on outcome of Part A
OTHER	Infectious Titre 4	TBD, depending on outcome of Part A

Timeline

• Start date: 2022-09-07
• Primary completion: 2022-12-19
• Completion: 2022-12-19
• First posted: 2022-10-07
• Last updated: 2023-09-13

Locations

1 site across 1 country: United Kingdom