NCT01265914

A Study to Evaluate the Safety, Tolerability and Immunogenicity of a Universal Influenza A Vaccine

A Randomised, Double-Blind, Placebo-Controlled, Ascending Dose Study to Assess the Safety, Tolerability and Immunogenicity of Repeated Intramuscular Administration of an Influenza A Vaccine (FP-01.1)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Immune Targeting Systems Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the safety, tolerability and immunogenicity of ascending doses of a novel, universal flu vaccine, in healthy volunteers.

Detailed description

FP-01.1 is composed of a mixture of synthetic peptides, modified with a fluorocarbon vector, which is anticipated to enhance the immune properties of the drug, and allows differentiation from recent investigational interventions by avoiding the use of adjuvant. The peptide sequences, derived from internal influenza-A proteins, were selected based on the presence of CD4+ and CD8+ T cell epitopes and a high degree of conservation across all influenza strains, using a proprietary bioinformatics approach, and, it is proposed, will enable FP-01.1 to universally treat influenza-A -infected populations. This study is the initial exploration of the safety, tolerability and immunogenicity response of FP-01.1 in healthy volunteers. Ascending doses of FP-01.1 will be assessed.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	FP-01.1	Ascending doses of FP-01.1 will be administered
BIOLOGICAL	placebo

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-03-01
• Completion: 2011-08-01
• First posted: 2010-12-23
• Last updated: 2012-03-26

Locations

1 site across 1 country: United Kingdom