NCT02071329

Safety, Tolerability, Efficacy and Immunogenicity of an Influenza A Vaccine (FP-01.1) in Healthy Volunteers Following Virus Challenge

A Randomised, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Efficacy and Immunogenicity of an Influenza A Vaccine (Vaccine FP-01.1) in Healthy Volunteers Following Virus Challenge

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Immune Targeting Systems Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety, tolerability, efficacy, and immunogenicity of an influenza A vaccine (vaccine: FP-01.1), as compared to placebo, in healthy volunteers following a dose of influenza A virus.

Detailed description

This study is designed to further investigate the safety and tolerability of FP-01.1 in healthy subjects and to explore the effect of prior vaccination with Vaccine FP-01.1 (250 μg/peptide) or placebo on the incidence, severity and duration of the signs and symptoms of influenza and the magnitude of viral load in nasal secretions and duration of viral shedding, after challenge with an A/California/H1N1 2009 influenza virus, in healthy male and female subjects. The study will also be used to provide additional information on the immunological responses (both humoral and cell-mediated immune \[CMI\] responses) following Vaccine FP-01.1 treatment and to investigate potential markers for protection against influenza A infection.

Conditions

• Influenza A

Interventions

Type	Name	Description
DRUG	Vaccine FP-01.1
DRUG	Placebo
OTHER	Virus Challenge

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-02-25
• Last updated: 2016-10-05

Locations

1 site across 1 country: United Kingdom