NCT04106817

Single Ascending Dose Challenge Study to Determine Safety and Reactogenicity of an Influenza Challenge Virus

A Phase I, Open-label, Ascending Dose Study to Determine the Safety and Reactogenicity of a Wild Type Seasonal A/California/ H1N1 2009 Influenza Challenge Virus in Healthy Volunteers, Following a Single Intranasal Administration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: WCCT Global · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a non-controlled, open-label, single-center, dose-escalation study to determine the safety, infectivity, and immune responses elicited from of the potential influenza virus challenge strain. The study objective is to determine the dose with the optimal safety profile and infectivity rate of the viral challenge strain in healthy volunteers for use in subsequent challenge intervention studies to test potential influenza vaccines and/or therapeutics.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Live, wild-type A/California/H1N1 2009 influenza virus	Live, wild type influenza A virus that was inoculated and manufactured in allantoic fluid of SPF embryonated hen eggs

Timeline

• Start date: 2015-01-19
• Primary completion: 2015-08-10
• Completion: 2015-08-10
• First posted: 2019-09-27
• Last updated: 2020-01-14
• Results posted: 2019-11-19

Regulatory

• FDA-regulated drug study