NCT02014870

Safety and Reactogenicity of a H1N1 Influenza Challenge Virus in Healthy Volunteers

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: 29 (actual)
• Sponsor: Immune Targeting Systems Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objective is to determine the dose level of live, wild-type A/California/ H1N1 2009 virus that has an appropriate safety and illness/infectivity profile to be used as an influenza virus, challenge strain in future intervention studies. Illness parameters were collected by subject symptom scores as well as by physical examination. Virus parameters were measured by PCR and cell culture assay (performed by VisMederi srl).

Conditions

• Influenza A

Interventions

Type	Name	Description
OTHER	1:1000 Live wild-type A/California/H1N1 2009	1:1000 dilution of neat virus
OTHER	1:100 Live wild-type A/California/H1N1 2009	1:100 dilution of neat virus
OTHER	1:10 Live wild-type A/California/H1N1 2009	1:10 dilution of neat virus

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2013-12-18
• Last updated: 2013-12-18

Locations

1 site across 1 country: Belgium